MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

New Technique Could Lead to Enhanced Biomedical Imaging

Researchers from MIT are designing a new imaging system that uses terahertz waves to penetrate deeper into surfaces to provide new high resolution imaging. 

Kristopher Sturgis

MIT Terahertz ScanningMIT researchers have created a prototype for a new imaging system that has the ability to image and identify the printed pages of a closed book, thanks to a system based on a band of electromagnetic waves known as terahertz radiation. Barmak Heshmat, a research scientist at MIT and one of the corresponding authors on the work, says that terahertz waves have shown real promise when it comes to exploring new imaging techniques.

"Terahertz waves have been under research for medical studies for several years now," he said. "Some of the studies have shown promise in detection of skin cancer using terahertzwater profilometry. Other studies have shown promise in the inspection of the coatings of drugs to see if the coating of a pill has been done correctly."

In their new study, Heshmat and his colleagues explored a range of different frequencies from 100 gigahertz to three terahertz, and found that these waves could penetrate through paper and many other materials. They also have begun sampling these pulses of light with very high time resolution, which can provide enough spatial resolution to separate between different surfaces -- allowing them to image surfaces with unprecedented clarity.

"Such high time resolution provides space resolution of about 20 microns, which is high enough to separate the pages of a closed book," Heshmat says. "We have developed an extended algorithm to enable this modality of imaging to be able to not only image, but also read through densely layered structures. As of now the resolution that is dictated by these frequencies is too coarse to beat any microscopy technique, however we are working to improve that resolution in some future studies. Having said that, because some of the chemicals can show contrast in this frequency range, terahertz radiations could be used to detect specific features of a disease."

Of course this wouldn't be the first attempt at using computational techniques to enhance medical imaging. Earlier this year IBM announced preparations to retool imaging software that could enable its supercomputer Watson to "see" and "read" images to interpret patient data. However, unlike IBM's efforts, Heshmat and his colleagues are working to create a whole new imaging system that can use algorithms that can gauge distance, and help penetrate deeper into surfaces. If the technique proves successful, we could see similar technologies crop up as imaging techniques advance.

"Terahertz technologies have been rising with a steady pace in the last decade," he says. "Terahertz waves are expected to take the lead in future communications where TBit per second channels are needed, and also as a complementary technology in inspection and biomedical imaging. For example, a new terahertz endoscope was demonstrated by a group of Korean researchers five years ago."

As they continue with their research, the group plans to continue exploring the different ways that terahertz waves can be used and exploited in various imaging techniques. Heshmat says that terahertz imaging is still a fairly new technology, and researchers will continue to work to improve the power and accuracy of the radiation sources so they can penetrate even deeper into surfaces.

"Right now we are focused on improving the spatial resolution of these types of systems," he says. "We also want to have a better signal to noise ratio, which is what our colleagues at MIT and around the world are working on."

Kristopher Sturgis is a contributor to Qmed.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of MIT]

Former J&J Sales Rep Convicted in Stolen Devices Scheme

U.S. federal prosecutors have netted convictions and $5 million in restitution in more than 20 cases through "Operation Miami Device."

Nancy Crotti

Judge gavel

A former sales representative at Johnson & Johnson's Ethicon Endosurgery subsidiary was convicted last week on charges of conspiring to transport stolen medical devices in interstate commerce, money laundering, and other charges.

A federal judge in Miami convicted Kerri L. Kaley, 50, of Cold Spring Harbor, NY, on seven felony counts in a criminal case arising out of a Miami-based FDA investigation. "Operation Miami Device" has led to convictions in more than 20 cases of medical device theft and has resulted in forfeitures, fines, and restitution totaling more than $5 million, according to a statement by the U.S. Attorney's office for the Southern District of Florida and the FDA Office of Criminal Investigations.

Kerri Kaley was employed at Ethicon Endosurgery between about 1989 and 2005, according to a report in the South Florida Business Journal. She and her husband Brian K. Kaley, and Ethicon, Inc. sales representative Jennifer Gruenstrass were indicted in February 2007, the report said. Gruenstrass worked for Ethicon from about July 1990 through May, 2005, according to the indictment. Charges remain pending against Brian Kaley, but no trial date has been set.

Product Development Models Driving Innovation

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapolis on September 21. Qmed readers get 20% off with promo code Qmed16.

From approximately 1995 through February 2005, Kerri Kaley participated in a conspiracy with a Long Island, NY-based group of other medtech salespeople from J&J subsidiaries, according to court records and testimony presented at trial. Kaley and others working with her obtained, through theft or fraud, "significant quantities of prescription medical devices" from nonprofit New York hospital customers, "which were then forwarded to a conspirator" who maintained F&S Medical Inc., in Delray Beach, FL, according to the indictment in the case. These devices were often state-of-the-art equipment used for minimally invasive surgery and the suture materials used throughout hospitals.

Kerri Kaley laundered over $2.2 million in payments through two sham construction corporations owned by Brian Kaley and used the funds to pay the co-conspirators, a home mortgage, home-renovation expenses, and child care, the statement and indictment say. A Miami-based conspirator solicited sales representatives and other employees of medical device manufacturers, seeking to purchase medical devices for re-sale. Three of Kaley's co-conspirators testified at her trial.

Kaley is scheduled for sentencing on December 2.  She faces up to five years in prison on the conspiracy charge, a maximum sentence of up to 10 years on each of the five substantive counts of transporting stolen property, and up to 20 years on the money-laundering conviction.  Kaley is also subject to fines on each of the seven counts of up to $250,000 per count.  Kaley agreed to forfeit $500,000 to the federal government, payable before her sentencing date, the statement said. Kaley also faces sentencing based on a November 2014 conviction arising in the same matter for obstruction of justice, which carries a potential sentence of 10 years' imprisonment and a fine of $250,000, the statement noted.

Nancy Crotti is a contributor to Qmed.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Salvatore Vuono on]

Are St. Jude Medical's Devices Secure? FDA Wants to Know

FDA is promising a "thorough investigation" of Muddy Waters's allegations against St. Jude Medical.

Maureen Kingsley

HackersIt is the latest in the unfolding story involving medical device manufacturer St. Jude Medical, activist investment-research firm Muddy Waters, and cybersecurity firm MedSec Holdings: FDA plans a "thorough investigation" of allegations Muddy Waters and MedSec have made about security vulnerabilities in St. Jude's cardiac devices.

"Regardless of the way a vulnerability comes to our attention, we take those allegations very, very seriously," Suzanne Schwartz, FDA's official responsible for cybersecurity, recently told Reuters. "We are putting all of our focus on making sure that we have an understanding of what these allegations are and do a thorough investigation of the claims."

An FDA spokesperson adds to Qmed that the agency is working with the Department of Homeland Security to investigate the findings of the report. As for patients with the cardio devices, they should talk with their doctors if they have questions or concerns.

Muddy Waters Research on August 25 announced its prediction that St. Jude Medical's shares would fall, claiming that "close to half of [the medical device company's] revenue is about to disappear for approximately two years," based on information provided to the research firm by cybersecurity company MedSec Holdings. "[St. Jude Medical's] pacemakers, ICDs, and CRTs might--and in our view, should--be recalled and remediated," Muddy Waters announced on its website and in a downloadable report, explaining that the cardiac devices in question collectively made up 46% of St. Jude Medical's 2015 revenue.

"Based on conversations with industry experts, we estimate remediation would take at least two years," the online statement reads.

Those aforementioned "industry experts," individuals at MedSec Holdings, believe that St. Jude Medical's pacemakers and defibrillators have cybersecurity flaws that hackers could potentially exploit to harm patients. Muddy Waters even posted a MedSec video that allegedly demonstrates cybersecurity vulnerabilities of a St. Jude Medical pacemaker.

St. Jude Medical's stock fell about 5% in value after the accusations were made; the stock has yet to fully recover. 

TAVR and TMVR are among the hottest technologies in medtech right now. Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21. Qmed readers get 20% off with promo code Qmed16.

For its part, St. Jude Medical has filed a lawsuit against Muddy Waters, MedSec Holdings, and three individual defendants who are principals in these firms for "false statements, false advertising, conspiracy, and the related manipulation of the public markets in connection with St. Jude Medical's implantable cardiac management devices," according to a press statement released by the company. "With this action, St. Jude Medical seeks to hold these firms and individuals accountable for their false and misleading tactics, to set the record straight about the security of its devices, and to help cardiac patients and their doctors make informed medical decisions about products that enhance and save lives every day," the press statement adds.

St. Jude Medical officials are pointing to a University of Michigan study that failed to reproduce Muddy Waters and MedSec's findings.

FDA Joins the Fray

FDA began its investigation of the matter in late August. It was reportedly unprecedented for a cybersecurity researcher to publicize claims about cyber bugs as part of a short-selling strategy; this approach also goes against advice that FDA issued in January in draft guidelines for dealing with cybersecurity vulnerabilities in medical devices. "It's important to note that FDA encourages cybersecurity researchers to work directly with manufacturers and the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) when potential vulnerabilities are identified," a spokesperson for FDA told Qmed. "In fact, a key component of our draft guidance on postmarket medical device cybersecurity is establishing and supporting formal policies for coordinated vulnerability disclosure, in which manufacturers and cybersecurity researchers work together openly in a trusted environment to identify, assess and remediate cybersecurity vulnerabilities before they can harm patients. This collaborative information sharing, disclosure and risk assessment enables all stakeholders to better address device safety."

FDA's Schwartz told Reuters that she hoped others would not follow the approach taken by Muddy Waters and MedSec.

Maureen Kingsley is a contributor to Qmed

Like what you're reading? Subscribe to our daily e-newsletter.

[Sinister hands on keybord image by User:Colin / Wikimedia Commons, CC BY-SA 4.0]

How Medical Technology Is Revolutionizing Combat Casualty Care

How Medical Technology Is Revolutionizing Combat Casualty Care

Former Navy SEAL medic David Rutherford says these advances in medical technology have saved countless lives on the battlefield.

In eight years as a Navy SEAL student, combat paramedic, and SEAL qualification trainer in locations ranging from Guam and Southeast Asia to Afghanistan, David Rutherford witnessed a significant evolution in battlefield medicine.

Beginning in the late 1970s, he said, the focus was on the so-called "golden hour," a tactic that sought to evacuate injured service members from the battlefield to a military hospital out of harm's way as quickly as possible in order to increase their chances of survival. But as military engagements shifted to remote locations such as Iraq and Afghanistan and troop numbers have scaled down, the thinking has changed.

"Nowadays, we've got units that are going into the field and staying in the field, and we simply don't have the assets that can pick them up," Rutherford said.

To adapt, he said, the military has put an increased focus on treating injured service members on the battlefield--a strategy that has relied in large part on advances in medical technology.

"It used to be that if you suffered a major arterial injury, you were going to die," Rutherford explained.

That was due in part, he said, to the military adhering to civilian physicians' advice that tourniquets, constricting devices used to stem bleeding from injuries to the extremities, should be avoided. The thinking was that the nerve damage that can sometimes result from use of a tourniquet could be worse than the original injury--advice that might have been sound in the civilian world but didn't always hold up in combat.

"During the Somalia incident portrayed in [the movie] Black Hawk Down, where we were still practicing under civilian-based guidelines, we lost personnel we believe unnecessarily because of not using tourniquets," Rutherford said.

Following that episode, research by a military physician supported employing these life-saving devices on the battlefield. Advances in the design of tourniquets--including better materials, Velcro, and a ratcheting system that allows individuals to apply a tourniquet to themselves--followed.

"Before, they were bulky, they were a lot heavier, and they weren't really user-friendly," Rutherford said. "Now, they're a lot more lightweight and user-friendly for the operator, so we've started employing them on a regular basis."

Today, he said, every service member that goes into combat carries a minimum of two tourniquets, and that has helped drive fatalities down.

Another technology Rutherford said has helped save the lives of military men and women is blood clotting agents. If a service member suffers femoral arterial bleeding in the pelvis region or a penetrating trauma to the abdominal or thoracic region, a tourniquet won't help. But the advent of hemostatic agents, such as QuikClot, Celox, and HemCon, has given combat medics another tool to control catastrophic bleeding. Such products can help initiate clotting within minutes, making it less likely that injured service members will exsanguinate before they can be evacuated to a treatment facility.  

"Now, if you've got someone with a major abdominal bleed and you can't tourniquet that, you can pull out five or six of these combat gauzes and clotting factors," Rutherford said.

The military began employing hemostatic agents in the early 2000s, and now Rutherford said he understands it is adopting yet another tool to help service members survive injuries that result in catastrophic blood loss: kits to perform in-field blood transfusions. Service members are cross-matched for blood type before going into battle, and these new kits enable them to transfer blood from the donor to the injured person with just a few basic supplies.

"Imagine being under fire for an extended period of time, and your buddy's bleeding out, and you get the call that nobody's coming. You're pinned down, and you don't have a refrigerator full of blood like the hospital would," Rutherford said. "You take the guy who's cross-matched already, and--boom--before you know it, you're transfusing blood to someone who's on the brink."

Rutherford, who was honorably discharged from the Navy in 2003 and now serves as a motivational speaker, said innovative battlefield medical solutions like this are only the beginning, too.

"Now they're looking at a fully mobilized field medical hospital or a mini crash system, how to deploy that in a low-profile way," he said, adding that systems might include things like an EKG, AED, surgical kit, portable ultrasound, and portable ventilator.

"We've got to prepare units for going into the field and staying in the field," Rutherford said. 

Jamie Hartford is MD+DI's editor-in-chief and serves as director of content for medical brands in UBM's Advanced Manufacturing Group. Reach her at [email protected] or on Twitter @MedTechJamie.

[image courtesy of TEAM FROGLOGIC]

Bring on the Drones and Robots

Bring on the Drones and Robots

Forget fears of a dystopian world controlled by artificial intelligence and robots. Patients are enthusiastic about the potential positives drones, robots, and other technology could bring to healthcare.

Who is worried about a future full of drones and robots? Not U.S. healthcare consumers. Turns out, we are pretty interested in taking advantage of technology-enabled healthcare and would welcome drones and robots for help in diagnosing and managing diseases.

That was one of the findings from the Deloitte 2016 Survey of U.S. Health Care Consumers. The survey asked 3751 American adults about technology-enabled healthcare, focusing on sensors and Internet of Things technology, telemedicine and remote patient monitoring, and robotics and drones.

Take part in the "Product Development with Sensors" track at the MD&M Minneapolis Conference on Thursday, September 22.

That Deloitte survey found that 70% of consumers would probably use at least one of these technologies and that telemedicine was the most preferred, with about 50% of respondents saying they were interested in using it. More of these consumers saw themselves using telemedicine for post-operative care and for keeping tabs on their chronic conditions, rather than for minor injuries and for healthcare on the road.

Of healthcare consumers, caregivers were most likely to use technologies like remote monitoring and telemedicine as part of their duties. This finding is supported by other reports that family caregivers are looking for products and services that offer value and improve health outcomes; AARP forecasts that this market will reach $279 billion by 2020. Patients with chronic conditions expressed the most interest in technology-enabled care, and the severity of their conditions correlated with their interest level. 

While there are already medical technologies that offer remote monitoring or incorporate a telemedicine element, drones and robots seem a little more futuristic. With the exception of robotic-assisted surgery, robots and drones are not yet mainstream in personal healthcare. But the Deloitte survey authors envisioned a few potential situations where a drone or robot could be useful--delivering medication and lab samples, diagnosing diseases, and offering home caregiving--and asked respondents how interested they were in using drones or robots for those capabilities. 

Their interest is shown in the figure below. A surprisingly high number of consumers are seemingly accepting of technology that isn't even available to them yet.

Of course, interest in a technology doesn't necessarily mean it will be used. The Deloitte survey authors wrote that "the gap between interest and use is substantial," noting that although about 38% of caregivers surveyed were interested in using remote patient monitoring, only 7% have used or currently use it. 

About two-thirds of the consumers surveyed expressed concerns about adopting telemedicine and remote patient monitoring. Those concerns were mainly around ensuring high-quality, personal, secure care via these technologies. Another issue that could impact future adoption of these technologies is the issue of paying for it. A large majority (about 80%) of the surveyed consumers said insurers should pay for remote monitoring and telemedicine.

As the survey authors wrote, "Yes, consumers are open to technology-aided care, but providers will likely need to earn their trust on both quality of care and protection of patient information."


Abbott, Alere to Seek Mediation in Merger Dispute

Alere, though, appears to be concerned about how fast its lawsuit is resolved. A multibillion-dollar medical device deal is on the line. 

Chris Newmarker

MediationAlere and Abbott have agreed to seek mediation over Alere's lawsuit in Delaware Chancery Court to compel Abbott to complete its planned $6 billion merger, according to Reuters

Reuters cited court filings showing the two medtech companies agreeing to use former judge William Chandler, though Alere is concerned over Chandler not being able to start the process right away. 

The diagnostic company's complaint, filed in late August, seeks to get Abbott to promptly obtain all the required anti-trust approvals. For their part, Abbott officials have been lukewarm about the deal, first announced in January, ever since Alere disclosed a federal grand jury subpoena related to a U.S. Foreign Corrupt Practices Act investigation involving sales practices from 2013 to 2015 in Asia, Africa, and Latin America. Abbott even offered up to $50 million to walk away from the proposed merger, but Alere's board rejected the offer.

The lawsuit goes as far as to claim that Abbott CEO Miles White vowed to create a "living hell" to get Alere to back out of the deal. 

Product Development Models Driving Innovation

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapolis on September 21. Qmed readers get 20% off with promo code Qmed16.

No matter what, the dispute could hurt Abbott's reputation in future M&A deals, according to an article by The Deal reprinted by The Street. Diagnostics company Cepheid, which Danaher is now paying $4 billion to acquire, could have been a lost opportunity for Abbott, the article muses. 

Abbott is also in the process of acquiring St. Jude Medical for $25 billion.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Pixab]

3-D Graphene Shows Promise For Bone Implants

Researchers from Rice University have welded together nanoscale sheets of graphene to form solid materials suitable for bone implants.

Kristopher Sturgis

3-D Graphene Rice UniversityRice University researchers have designed a new method to create highly complex shapes in a matter of minutes using graphite molds, which could be a simpler process than specialty metals. Chandra Sekhar Tiwary, postdoctoral research associate at Rice and co-lead author on the work, says that graphene offers remarkable strength as a material.

"Graphene, or just atomically thin graphite, is proposed to be the strongest material," he says. "But in order to make it useful in structural application we have to connect them. Spark plasma sintering is one of the methods that can weld graphene oxide at large scale without destroying its dimension, and the results have given rise to high strength with high porosity."

Tiwary says that spark plasma sintering (SPS) has been used in the past to make complex parts, typically with ceramics. The technique involves a high pulse current that welds the nanoscale sheets of graphene together, creating a material that is almost 50 percent porous and half the density of graphite. It also has 40 megapascals of compressive strength, which makes the material suitable for bone implants.

"The specific strength, or the strength to density ratio for graphene-based materials is very high," Tiwary says. "We were also able to make it porous and it can be processed at very low temperatures."

How 3-D Printing Will Transform Medtech

Find out how process innovations in 3-D printing are enabling next-generation medical devices at the MD&M Minneapolis conference on September 22. Qmed readers get 20% off with promo code Qmed16.

The group was able to control the density of the material by raising and lowering the sintering temperatures that deliver the localized heat that welds the nanoscale graphene. The next step was to measure the load-bearing capacity of the material. In collaboration with colleagues at testing technology company Hysitron in Minnesota, the team performed stress tests with a picoindenter attached to a scanning electron microscope and found that the welded graphene materials were stable up to 70 micronewtons.

Graphene has been touted as the next wonder material that could eventually replace silicon in electronic devices. With its one-atom thick lattice of carbon atoms, the material was thought to be an ideal upgrade on silicon given its ability to allow for the rapid movement of electrodes through its two-dimensional form. Recently other materials have emerged, like black phosphorus, to give graphene a run for its money -- but Tiwary believes there's still a lot left to explore with graphene.

"There have been lots of exploration with graphene since 2010, but we believe there's a lot more to still explore," he says. "Our current work is just an initial study, as there is still a lot of optimization and engineering needed to make this technique ready for commercial use."

As they continue to refine the technique, the group aims to engineer two-dimensional graphene layers into scalable 3-D solids with appropriate density and strength. Recently the group discovered that the sintering process has the ability to reduce graphene oxide flakes to a bilayer of pure graphene, which makes them even stronger and more stable than graphene oxide.

The group believe this technique demonstrates the significant potential of graphene as a useful material in emerging technologies, and could soon be adapted into materials for bone replacement and other therapies.

Kristopher Sturgis is a contributor to Qmed.

Like what you're reading? Subscribe to our daily e-newsletter.

Image courtesy of Rice University]

Meet The Octobot: The World’s First Autonomous Soft Robot

Researchers designed the new 3-D printed robot entirely from soft materials. It is powered by chemical reactions controlled by microfluidics.

Kristopher Sturgis

Wyss OctobotResearchers at Harvard University's Wyss Institute have unveiled their latest innovative robotic design: a 3-D printed robot nicknamed "octobot."

The nickname octobot was inspired by the octopus, which served as a source of inspiration for the group given the mollusc's  ability to perform great feats of strength and flexibility, despite lacking an internal skeletal system.

Michael Wehner, postdoctoral fellow at the Wyss Institute and co-first author on the work, says that the biggest challenge has always been replacing traditional hardware with soft components.

"The main challenge in building a completely soft robot was the need to eliminate so many traditional components," he said. "This endeavor required us to rethink the way robots are designed from the bottom up. The soft robotics field has long desired to use hydrogen peroxide as a fuel, and pneumatic actuators are relatively common in soft robotics. Embarking on this project allowed us to embrace monopropellant fuel, pneumatic actuation, microfluidics, and combine them all using the novel embedded 3-D printing technology."

This means the octobot is essentially powered by gas under pressure. The technology was designed so that a reaction inside the robot can transform a small amount of hydrogen peroxide into a large amount of gas, which then flows into the octobot's arms to inflate them. Wehner says that 3-D printing was a crucial component of the design process, as it allowed them to successfully integrate soft components.

"While 3-D printing is a very broad area, the techniques of embedded 3-D printing were critical in developing the techniques to build octobot," Wehner says. "The disparate areas of liquid monopropellant energy conversion, microfluidics, kinematics and dynamics, actuation, and robotics could not have been successfully integrated without using this novel 3-D printing technique. As researchers around the world expand 3-D printing capabilities, such as the embedded 3-D printing we used, the design possibilities will expand as well."

Don't miss the MD&M Minneapolis conference and expo, September 21-22, 2016. Qmed readers get 20% off with promo code Qmed16. 

Robotics have long been hailed as one of the most promising areas of technology in the medical device industry, but lately their role has become a bit less clear. The elevated costs associated with their implementation, as well as the training and compatibility issues that come with robotic technologies have stymied their impact. However, Wehner sees soft robotic technologies carving out their own niche, separate from traditional robotics in the realm of medical technologies.

"Of course traditional robots are extremely useful in a wide variety of tasks, however, there are several areas in which traditional robots are not well suited," he said. "In fields where a gentle touch is more important than a rigid grasp, we believe soft robots will emerge as the winner. Soft robotic grippers are already being used to handle undersea structures in scientific research. One can easily envision soft robots being used to handle fragile objects such as crops, or even living beings. Internal medicine and wearable devices are also likely areas for future soft robots."

For now, Wehner and his colleagues at Harvard hope to continue their research in an attempt to develop more soft robotic technologies with enhanced capabilities that can better understand and respond to the environment around them. Above all else, the hope is that this breakthrough can be the beginning of a new generation of robotic technologies.

"We certainly hope that our work will serve as an inspiration for other researchers," Wehner said. "It has certainly inspired us to think about additional possibilities, and we could not have completed our work without relying on publications of previous work, so we hope to inspire others as well. We are excited to move this research forward. We could definitely foresee building future soft robots with more sophisticated actuation and control, including more complex gait cycles and robots that sense and respond to their environment."

Kristopher Sturgis is a contributor to Qmed.

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Wyss Institute]

New Philips Device Could Improve Cancer Treatment

The launch is the latest from Philips in a string of medical product releases aimed at making healthcare more personalized, targeted, and cost-effective

Maureen Kingsley

Philips OncoSuitePhilips plans a European launch of a next-generation, interventional oncology-treatment system, with the debut planned at the Cardiovascular and Interventional Radiological Society of Europe's annual meeting (CIRSE 2016) in Barcelona next week.

The system, dubbed OncoSuite, will be used by physicians to provide both analysis and targeted, minimally invasive treatment of tumor lesions, thereby reducing damage to healthy surrounding tissue during patient treatment. The system offers clinicians a better view of treatment targets while the clinicians perform procedures, resulting in more-informed decision making.

Optimized for Liver Treatment

Jeff Geschwind, MD, chair and chief of the Department of Radiology and Biomedical Imaging at the Yale School of Medicine, explained in a Philips press release that the OncoSuite system is optimized for treating patients with liver cancer but can be used on patients with other cancers as well, including bone, kidney, and lung cancer. "Given the steady increase in the prevalence of non-alcoholic fatty liver disease and liver cancer, the development and availability of new technology is much needed to provide interventional oncologists with a breakthrough that allows best possible treatment for these patients," Geschwind said in the press release.

The OncoSuite system integrates tumor embolization and ablation procedures with Philips' interventional x-ray systems, enabling physicians to target multiple tumor lesions simultaneously. Philips boasts that the OncoSuite is the "only platform in the industry" to do so, according to the company. The system comprises an enhanced-imaging product (XperCT Dual), a live 3-D image guidance product for tumor embolization (EmboGuide), and a live 3-D image guidance product for tumor ablation (XperGuide).

"Minimally invasive, image-guided interventional oncology procedures are a highly effective option for patients who cannot be treated through conventional techniques such as surgery, chemotherapy, or radiation therapy," said Ronald Tabaksblat, business leader, Image Guided Therapy Systems at Philips, in the company's press announcement. "Interventional oncology procedures are rapidly increasing, and OncoSuite provides the first complete interventional oncology portfolio for interventional radiologists, enabling physicians to see the entire tumor and its feeder vessels to directly target treatment [while] avoiding healthy tissue."

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

To that end, the Open Trajectoryfunction within the XperCT Dual portion of the system enables better centering of the liver with significantly improved visualization of peripheral hepatic tumors in a single sweep during the procedure. This feature can effectively scan larger patients by providing a more targeted field of view. Previously, the press release states, with the traditional geometric movement of the C-arm within the interventional X-ray system, part of the liver image was cut off, and larger patients required multiple scans to visualize tumors in the periphery of the liver.

Incorporates Imaging for Radio-Opaque Bead Technology

OncoSuite also features what Philips calls "the world's first optimized imaging" for LC Bead LUMI, the result of a collaboration between Philips and healthcare-specialist company BTG that provides real-time visible confirmation of radio-opaque bead location during their use in tumor-embolization procedures. Additionally, wiper movement functionality improves workflow with automatic dual-phase imaging, helping physicians to acquire two 3-D cone-beam computed-tomography datasets at different times during the procedure in a single step.

Philips' Growing Health Tech Portfolio

Philips' 3% overall comparable sales growth was driven by a 5% growth in its health technology portfolio, according to the company's first-quarter 2016 report. The OncoSuite system is the latest of many recent product launches by Philips in the healthcare space. In August of this year the company rolled out a handful of mobile health-monitoring devices that pair with its HealthSuite app for iOS and Android platforms. These include a fitness wristwatch, an ear thermometer, a body-analysis scale, and a blood-pressure analyzer.

Earlier in 2016, Philips' Minicare I-20, a small, handheld, point-of-care heart-attack diagnostic device requiring only one drop of blood, earned the CE Mark in Europe and is now being sold in the U.K., the Netherlands, Germany, and Belgium.

Maureen Kingsley is a contributor to Qmed

Like what you're reading? Subscribe to our daily e-newsletter.

[Image courtesy of Philips]

What's Behind FDA's Warning Against Ovarian Cancer Screening Tests?

What's Behind FDA's Warning Against Ovarian Cancer Screening Tests?

Earlier detection of cancer is a good thing, right? So why did FDA just warn against ovarian cancer screening tests? 

This week, the agency published a safety communication warning against using currently available ovarian cancer screening tests. The recommendation, which came during Ovarian Cancer Awareness Month, is because "there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results," FDA wrote.

Learn about "Best Practices in Developing Products Within a Highly Regulated Environment" at the MD&M Minneapolis Conference, September 21-22.

By coming down hard on ovarian cancer screening, FDA joins other medical professional societies and groups. The Choosing Wisely initiative, run by the American Board of Internal Medicine (ABIM) Foundation, offers information on ovarian cancer screening tests, stating that "results are not always effective" and that they can lead to dangerous, unnecessary, and costly procedures. Choosing Wisely does point out that a CA-125 test and ultrasound can be useful if a woman has ovarian cancer symptoms or is at high risk.

The U.S. Preventive Services Task Force also recommends against ovarian cancer screening, giving it a "D" grade.

Ovarian cancer screening tests usually include measurement of the protein cancer antigen 125 (CA-125). The CA-125 test is used to monitor ovarian cancer during and after treatment, but is not recommended for screening because a high level can be caused by a variety of conditions (even menstruation) and a normal level is often seen in patients with early-stage cancer, according to Choosing Wisely.

FDA wrote that it is concerned about the impact of false-positives and false-negatives from screening tests, noting that "available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer." The agency added that women at higher risk of ovarian cancer may also be harmed by "unproven ovarian cancer screening tests"  because a test result showing no cancer may dissuade them from doing anything to reduce their risk.

In addition to its recommendation against screening tests, FDA urged women with a higher risk of ovarian cancer to "be aware that there is currently no safe and effective ovarian cancer screening test" and not to depend on screening test findings.

Cambridge, UK-headquarted Abcodia makes the ROCA test, marketed as a way to determine the likelihood of ovarian cancer in postmenopausal women between 50-85 years old and women with a higher risk between 35-85 years old. According to the corporate website, the ROCA test is available in the United Kingdom, as well as almost all U.S. states.

Information on Abcodia's corporate website markets the benefits of the test, including detection of 85.8% of ovarian cancers, 99.8% efficacy in determining women who do not have ovarian cancer, and detection of twice as many ovarian cancers as the CA-125 blood test. But the company also acknowleges the "limitations" of the ROCA test, including that "up to 14.2% of women with ovarian cancer may be missed" and that it should not be the only test used to decide whether a patient should have surgery.

Data on the ROCA test comes from clinical trials, including the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which included more than 200,000 patients. Though UKCTOCS involved about 15 years of research, some onlookers were critical. A June 2016 editorial in the American Family Physician claimed the results "did not show convincing effectiveness" because the mortality reduction was not statistically significant, was not constant, and only a quarter of patients were subject to followup long enough to show potential benefit. 

Abcodia did not have a statement on FDA's communication available at press time, but this article will be updated for any comment from the company. [Editor's note: On September 13, Abcodia said in a statement it is voluntarily and temporarily suspending U.S. commercial availability of the ROCA Test. Read more here.]

Another company that makes an ovarian cancer-related test--not a screening test--praised FDA's decision. ASPiRA Labs, a Vermillion company, makes the OVA1 and OVERA FDA-cleared tests to evaluate risk of malignant ovarian cancer in women slated for surgery for pelvic mass. 

"We believe this clarity around the use of non-FDA approved test for ovarian cancer screening, demonstrates the need to manage high risk pelvic mass patients at the onset with our FDA cleared technology," Valerie Palmieri, president and CEO of Vermillion/ASPiRA Labs, said in a release

The Ovarian Cancer Research Fund Alliance (OCRFA) cheered FDA's statement this week. "We share the FDA's concern that the ROCA Test, which is being marketed directly to women in 47 states, may do more harm than good," said Audra Moran, OCRFA president and CEO, in a release. "The money spent marketing tests of questionable benefit would be much better spent on research to find an effective test, better treatments and a cure."