New Diabetes Device Assembles Itself

GI Windows' technology delivers magnetic parts via endoscope that then self-assemble in the small bowel, forming an anastomosis before passing out of the body. 

Arundhati Parmar

GI Windows Animation from Jared Kornblatt on Vimeo.

Diabetes drugs abound, but many startups are taking the device approach to manage type 2 diabetes, an expensive and chronic condition.

There's Fractyl Laboratories, based in Waltham, MA, that is testing an endoscopic procedure to ablate a portion of the duodenum mucosa in a bid to provide better glycemic control for the patient.

And now another company that believes in the anti-diabetic effect of bariatric-surgery like Fractyl is also developing an endoscopic procedure.

GI Windows, based in West Bridgewater, MA, presented the data this week at Digestive Disease Week in San Diego, CA, for the new treatment that uses self-assembling magnets that showed that at six months there was significant reduction of A1c levels and fasting glucose levels.

So, how does the procedure work?

The dual-path enteral diversion is created with a flexible endoscope through which smart, magnetic devices are deployed from the scope. These magnets then assemble themselves in the small bowel. The devices transform from a "linear shape to an octagonal geometry and then couple to form an anastomosis--a connection between two hollow or tubular structures or organs," according to a news release. These coupled devices are eventually expelled from the body naturally thereby leaving behind an anastomosis but without any residual foreign implants or materials.

The 10 obese patients who were enrolled in the study had a mean BMI of 41 and were restricted to a two-week liquid/soft diet following the procedure. These patients underwent an X-ray of the upper GI tract to confirm "anastomotic patency" (the degree of openness or exposure) at two weeks after the magnets were introduced. They also received follow-up endoscopes at two and six months so physicians could see the anastomosis.

At six months the results were as follows: For patients with pre-diabetes, HbA1c levels were reduced to 5.25% from a mean baseline of 6.1%. Fasting blood glucose levels decreased to 105 mg/dl from 119 mg/dl. Patients with Type 2 diabetes showed a decrease of HbA1c to 6.0% from a mean baseline of 7.8%, with a decrease in fasting blood glucose levels to 111mg/dl from 177 mg/dl. All patients had fasting blood glucose levels move from the diabetic or pre-diabetic range to the normal range at six months. The mean weight loss for all patients was about 28 pounds (12.9 kg) or a 10.6% decrease in total weight loss.

The strong results warrants further trials involving GI Windows' Incision-less Anastomosis System as an option to treat type 2 diabetes in obese patients.

"The results from this six-month study are promising and suggest that the IAS, which relies on mechanisms of action proven in surgical approaches, has the potential to markedly reduce HbA1c, fasting blood glucose levels, and weight in obese patients with Type 2 diabetes," said Ev?en Machytka, MD, a study investigator from Czech Republic's Ostrava University Hospital, in the news release. "These findings warrant further investigation of the IAS technology."

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Arundhati Parmar is a senior editor at UBM.

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Did Walgreens Fail to Do Its Theranos Homework?

The drugstore chain feared the blood-testing startup would choose a retail partner if it pushed too hard, according to the Wall Street Journal.

Nancy Crotti

Walgreens didn't vet Theranos enough before making a deal to have the blood-testing startup set up shop in its stores, the Wall Street Journal reported.

Now the drugstore chain may have given up on recouping at least $50 million it invested in deeply troubled Theranos, which promised to perform multiple tests from a single drop of blood, the newspaper said.

Also, a disgruntled consumer has sued Theranos in California for alleged fraud in a filing that could become a class action, according to a report by The Verge.

Walgreens' queasiness centers around findings of unreliability in Theranos' proprietary Edison technology, which federal regulators said in January may even put patients' health in "immediate jeopardy," the Journal reported. Officials of the drugstore chain are concerned about its reputation and the possibility that Theranos might sue for breach of contract, leaving it vulnerable to billions of dollars in damages, the newspaper added.

Walgreens, which had been Theranos' biggest customer, wants to dump the company and hopes close its 40 or so blood clinics mostly based at in retail locations in Arizona, the Financial Times reported in February.

Theranos today reiterated its commitment to the relationship. "We value our partnership with Walgreens and look forward to continuing to work together," said Theranos spokesperson Brooke Buchanan in an email.

Walgreens did not immediately respond to a request for comment.

Walgreens Boots Alliance Inc. (Deerfield, IL), entered the deal with Theranos in 2013 despite the startup's failure to divulge information typically sought in such deals, according to the Journal. Walgreens officials had never even set foot inside Theranos' lab, so jealously did the startup guard its secrets.

A retired Quest Diagnostics Corp. executive who visited Theranos on Walgreens' behalf told the Journal he was not allowed to enter the lab, but was led to believe the results of tests he reviewed were run on Edison equipment.

Former Theranos employees told the newspaper that the company used the Edison technology on "just a fraction its tests." The newspaper also reported that the company recently told CMS that it performed only 12 types of tests on the Edison and the rest on conventional laboratory equipment, according to an unnamed source cited by the newspaper.

The consumer lawsuit, filed in U.S. District Court for the Northern District of California, focuses on the frequency of Theranos' use of Edison for blood testing, CMS reports questioning the company's testing practices, and on allegations of false advertising.

Theranos believes the lawsuit is without merit and pledged to vigorously defend itself, Buchanan said.

The U.S. Justice Department is investigating Theranos for alleged fraud. CMS threatened to ban CEO Elizabeth Holmes and company president Sunny Balwani from the business. Balwani subsequently retired. The Silicon Valley startup became well-known for its blood-testing technology, which promised to perform multiple diagnostic tests with a single drop of blood.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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Health Held Hostage: Ransomware in the Health Care Industry

Health Held Hostage: Ransomware in the Health Care Industry

Criminals are increasingly using ransomware to target healthcare organizations. What do these attacks entail?  

Raj Mehta

As organizations improve the maturity of their cyber risk programs and capabilities, cybercriminals also continue to look for innovative ways to drive their revenue streams. One such rapidly increasing attack mechanism is ransomware. Ransomware is a category of malicious software ("malware") that encrypts a user's disk drives and demands some form of compensation in return for critical data held hostage.

Over the past year, healthcare organizations, particularly providers, have been attractive targets for cybercriminals.

These criminals have recently updated their arsenal with ransomware to conduct attacks on healthcare providers, resulting in severe impact on healthcare operations and potential risk to patient safety. This industry was not considered a primary target for ransomware attacks until recently, but events of late suggest that ransomware may increasingly be aimed at healthcare organizations using social engineering and other tactics. It has become critical for healthcare organizations to understand the potential impact of ransomware on healthcare operations and patient safety, and be prepared in the event that they experience such an attack directly.

A typical method of infection is an email containing a malicious attachment that will download the ransomware. Infection with ransomware may compromise sensitive files, rendering those files and associated systems inaccessible to health personnel, thereby disrupting normal operations by inhibiting access to, for example, patient records, appointment information, and test results. Financial loss is also very likely to affect the targeted companies, as a ransom payment is demanded by the threat actor, with the promise that once payment is received, a decryption key will be provided to restore compromised files.

Users may encounter this threat through a variety of means. Ransomware is often distributed as attachments to a series of spam campaigns. Ransomware can also be downloaded by unwitting users who visit malicious or compromised websites, or it can arrive as a payload, dropped or downloaded by other malware. The most recent versions of the virus are TeslaCrypt and Locky, which encrypt files on a computer's hard drive and any external/shared drives, then direct to a payment page that requests a ransom amount.

Ransomware attacks are financially motivated. Attackers target organizations to extract a ransom payment or target the theft of critical data such as electronic protected health information (ePHI) and personally identifiable information (PII). Because health care organizations cannot afford to be paralyzed for long periods, there may be a higher likelihood that ransom fees will eventually be paid. Other reasons healthcare providers, in particular, are attractive targets include a lack of training and awareness. Employees and staff are often not adequately trained on how to avoid being hacked and the organization may be using outdated software and technologies that are more susceptible to attack.

For healthcare providers, a ransomware attack can be particularly significant. Pursuing valuable ePHI, attackers are aware of exploitable vulnerabilities and are opting to hold hospitals hostage rather than use traditional data theft methods. Information at hospitals is time-critical; sudden lack of access to critical data in emergency rooms and operating rooms could result in substantial disruption and threat to patient lives and safety. Potential impacts can include disruption of operations, loss of, or inability to access key information, breakdown of communication, unauthorized disclosure of PHI/PII, intellectual property, or other confidential electronic health records (EHR), and reputational and brand impact.

The cost of investing in cybersecurity can pay huge dividends over the long-term. Healthcare organizations need to analyze and weigh the importance of these investments against the potential impact of ransomware and other types of cyber-attacks. Such attacks are likely to continue to evolve in complexity and frequency, and a mature cybersecurity program can help reduce the impact of these attacks. The most secure, vigilant, and resilient organizations have focused and well-configured technologies and well-defined and executed security processes to prevent and detect threats, as well as contingency plans to help reduce the impact of such attacks as much as possible.

Raj Mehta is a partner in Deloitte's Cyber Risk Services.

[Image courtesy of BOAZ YIFTACH/FREEDIGITALPHOTOS.NET]

It's Medtronic & Qualcomm Vs. Google & Dexcom in Race to Develop Next-Gen CGM

It's Medtronic & Qualcomm Vs. Google & Dexcom in Race to Develop Next-Gen CGM

Both partnerships aim to develop low cost, smaller, disposable continuous glucose monitoring systems that leverage data and analytics to provide actionable insights to diabetes patients.

Arundhati Parmar 

Back in August 2015, continuous glucose monitoring firm Dexcom announced that it would be partnering with Verily, formerly Google Life Sciences to build smaller, cheaper, disposable CGM sensors beefed up with analytics.

Here's how Dexcom's CEO, Kevin Sayer, described the effort in a November earnings call. 

We intend to work together to develop simple low-cost sensor systems integrated into advanced data analytics platforms to improve diabetes care from pre-diabetes all the way through intensive insulin therapy. We expect these advances will make diabetes management much more convenient and flexible than ever before, and we are excited for the promise this technology holds for patients and caregivers.

Now another medtech heavyweight is intending to make CGM devices much for affordable for a broad swath of people. Medtronic announced Wednesday that it is partnering with Qualcomm Life, a subsidiary of tech company Qualcomm, to jointly develop a next-generation CGM system that will incorporate a new sensor and smaller design. These single-use, disposable CGMs would be able to provide both near real-time and retrospective glucose data to type 2 diabetes patients. 

"Our vision is to transform diabetes care so people with diabetes can enjoy greater freedom and better health," said Laura Stoltenberg, vice president and general manager, Non-Intensive Diabetes Therapies at Medtronic, in a Medtronic news release. "We are thrilled to be collaborating with Qualcomm Life - a best-in-class leader in wireless technologies that is ahead of the curve in a rapidly changing connected world - to develop innovative and affordable CGM systems that will fundamentally change type 2 diabetes management." 

Stay on top of medtech trends and attend the MD&M East conference at the Jacob Javits Convention Center in New York, June 14-16.

Type 2 diabetes patients typically stick their fingers twice a day to get glucose readings 

Medtronic is a dominant player in type 1 diabetes market but this move corresponds with the desire of Medtronic CEO, Omar Ishrak, of capturing the much larger, type 2 diabetes market segment. Ishrak made an unexpected entrance at CES in Las Vegas this year, sharing the stage with GE's Ginni Rometty to unveil a research prototype concept for a first-of-its-kind cognitive app that can help to detect critical patterns and trends for people with diabetes to making daily management of diabetes simpler. That yet-to-be-released cognitive computing app offered a tantalizing possibility: In a research study of 600 patient data that was de-identified, findings suggest that cognitive computing can predict a low-glucose event three hours before its onset. 

The partnership with Qualcomm is also to enable that actionable insight although this partnership is presumably a more R&D-intensive process to develop a wholly new kind of CGM device that will leverage Qualcomm Life's wireless heft.

That subsidiary has been hard at work in developing its 2net Design platform that can design the communications components of connected medical devices including disposable drug delivery and disposable diagnostic devices. The platform provides end-to-end connectivity designed to meet FDA and HIPAA safety and privacy standards.

"This collaboration furthers our commitment of enabling new connected care models that liberate vital data and unlock insights to deliver intelligent care wherever the patient may be," said Rick Valencia, president and general manager, Qualcomm Life, in the release.

No timeline was offered regarding when such a system would be launched. Dexcom in comparison, is gearing up for the first product to launch in 2018. Irrespective of who wins the race, if these companies are successful in developing approved, effective products that function as advertised, the real winner may be diabetes patients. 

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com  and on Twitter @aparmarbb

Think Your Non-Connected Device Is Safe from Cyber-Attacks? Think Again

Think Your Non-Connected Device Is Safe from Cyber-Attacks? Think Again

A medical device doesn't need to be connected for cybersecurity to be an issue. Here are the threats you need to know.

Stephanie Domas

There have been a number of medical device conferences over the past few months, with some focusing on medical device cybersecurity. While attending these conferences, I enjoy finding opportunities to engage medical device manufacturers on the topic of cybersecurity and how they currently address it. Nothing makes me happier than learning that they are proactively designing security into their devices. However, one of the most common things I still hear is, "Our devices aren't connected, so we don't have to do anything about cybersecurity yet."

Wrong.

Any device that speaks in 1's and 0's has a cyber-attack surface, not just devices that are connected to the internet. Understanding your device's attack surface allows you to understand your device's unique threat model. Your device's threat model derives from a holistic view of its features and functionality and contains the malicious acts, whether intentional or not, that could afflict your device.

Stephanie Domas will be part of a roundtable discussion on "Cyber Security, Compliance, and Patient Privacy" at the MD&M Minneapolis Conference, September 21-22.

One of the characteristics we consider when building a threat model is the attack vector, or method for a threat to be executed. An option we examine is remote threats, or threats that can take place over the internet. These are threats against connected devices. However an alternative vector we consider is physical access threats, meaning the attacker having physical access to the device. Devices with no 'connectivity' still have a physical access attack surface.

With physical access there are a wide range of threats we have to consider. There are the easiest physical access threats, stemming from exposed communication ports such as USB or serial lines. These offer someone with physical access easy methods of potentially manipulating the system or accessing sensitive data (including both PHI and intellectual property).

Digging deeper, we then consider threats that could occur when an attacker opens up a medical device enclosure. Now, internal headers, often used for debugging and programming, start to be considered. Think about it: what can an attacker access and change through these ports? And it goes even deeper: a motivated attacker can make board modifications, such as soldering onto components that didn't have exposed programming headers or soldering onto an internal communication bus to intercept or manipulate internal board communication. What happens if they manipulate communications? What data can they access?

Beyond the physical access threats, another reason to consider cybersecurity is the fact that medical device design is often an iterative process. The next version of your medical device typically builds on the previous version. There is increasing pressure from industry for more connectivity in medical devices. When the pressure reaches your device family--and it eventually will--if you haven't considered cybersecurity previously, you might find you have to redesign your device from the ground up. 

Truly, cybersecurity is not limited to only connected medical devices--and while no device can ever be 100% secure, integrating secure design principals can provide patients with a greater quality of care through medical devices they can trust.

Stephanie Domas is lead medical device security engineer at Battelle

[Image courtesy of MRPUEN/FREEDIGITALPHOTOS.NET]

This Test Can Find a Single Virus in Urine

The test from the University of Texas has implications for field use in detecting catastrophic viruses like Zika.

Nancy Crotti

human cytomegalovirus University of Texas urine test
The researchers demonstrated their new technique on a the murine cytomegalovirus, which is related to a herpes virus, shown here. (Image courtesy of the University of Texas at Austin)

A pair of University of Texas at Austin graduate students has come up with a test that can rapidly detect a single virus in urine, according to the university.

Although the technique presently works on just one virus, the researchers say it could be adapted to detect a range of viruses that plague humans including Ebola, Zika and HIV, a university statement said. The work was reported in the Proceedings of the National Academy of Sciences.

"The ultimate goal is to build a cheap, easy-to-use device to take into the field and measure the presence of a virus like Ebola in people on the spot," said Jeffrey Dick, a chemistry graduate student and co-lead author of the study. "While we are still pretty far from this, this work is a leap in the right direction."

The other co-lead author is Adam Hilterbrand, a microbiology graduate student.

The method is based on electrochemical collisions and provides for a selective, rapid, and sensitive detection technique, according to the journal article. Itis only sensitive to one type of virus, filtering out possible false negatives caused by other viruses or contaminants.

Other commonly used virus-detection methods used with biological samples have drawbacks, according to the researchers. One requires a much higher concentration of viruses, and the other requires samples to be purified to remove contaminants. The new method, however, can be used with urine that comes directly from a person or animal.

The researchers demonstrated their new technique on a the murine cytomegalovirus, which belongs to the same family as the herpes virus. To detect individual viruses, the team placed an electrode that is thinner than a human cell in a sample of mouse urine. They then added molecules made up of enzymes and antibodies that naturally stick to the virus of interest. When all three stick together and collide with the electrode, the collision creates a spike in electric current that can be easily detected.

The researchers acknowledged that their new method needs refinement. For example, the electrodes become less sensitive over time because a host of other naturally occurring compounds stick to them, leaving less surface area for viruses to interact with them. To be practical, the process would also need to be engineered into a compact and rugged device that could operate in a range of real-world environments.

Others have come up with field tests that can detect viruses in blood. MIT, Harvard University, and other research institutions are working on a practical and cost-effective Zika diagnostic tool for widespread use. STMicroelectronics (Geneva) and Clonit, together with with Italy's National Institute for Infectious Disease Lazzaro Spallanzani, announced a portable analyzer to detect the Ebola virus in 2014.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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J&J Hit With Lawsuits From State AGs

Attorneys general from California and Washington state allege false advertising, deceptive marketing, and "knowingly concealing the risks" when it came to pelvic mesh implants.

Nancy Crotti

Judge gavel
(Image courtesy of Salvatore Vuono on FreeDigitalPhotos.net)

The attorneys general of California and Washington state have filed consumer protection lawsuits against Johnson & Johnson over pelvic mesh implants.

The California complaint alleges that J&J neglected to inform both patients and doctors of "possible severe complications" and misrepresented the frequency and severity of risks."

Washington's suit claims J&J's "deception" resulted in thousands of women facing urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.

Thousands of lawsuits have been filed over pelvic mesh, which was designed to help women suffering from stress urinary incontinence and pelvic organ prolapse. J&J, whose Ethicon unit manufactured mesh for pelvic organ prolapse until 2012, has won some and lost some. It continues to make mesh for urinary incontinence. Other companies that have faced lawsuits over vaginal mesh products include American Medical Systems, Boston Scientific, C.R. Bard, Cook Medical, Endo Health, and Coloplast.

Complications from the implants may crop up years after surgery and are sometimes irreversible. Because the mesh was not designed to be removed, it may take multiple surgeries and still prove impossible. A California patient said a consultant likened excising the mesh to "trying to remove chewing gum from hair."

California co-led a multistate investigation, including 46 states and the District of Columbia, into J&J's surgical mesh products for women, and is seeking injunctive relief and monetary penalties. The AGs of California and Washington pledged to hold J&J accountable.

"Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products," said California attorney general Kamala Harris in a statement. "Johnson & Johnson's deception denied women the ability to make informed decisions about their health and well-being."

"It's difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson's deception," said Washington AG Bob Ferguson in a separate statement. "They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products' risks, essentially duping doctors into using their own patients as clinical trials."

J&J vowed to vigorously defend itself and Ethicon, calling the AGs' decision to sue the companies "unjustified."

"The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," the companies said in an email statement. "The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research."

The statement called the mesh slings "the worldwide standard of care for surgical treatment of stress urinary incontinence" and cited theAmerican Urogynecologic Society's statement, "the polypropylene midurethral sling has helped millions of women with [stress urinary incontinence] regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly."

In a separate statement, the nonprofit physicians' organization acknowledged risks to implanting mesh to treat pelvic prolapse, but added this:"It is our strong opinion, that there are subsets of women with prolapse, and in some cases those with the most advanced disease, in whom the benefits of transvaginal mesh outweigh the risks." 

J&J's Ethicon subsidiary sold 787,232 pelvic devices nationally from 2008 to 2015 including more than 42,000 in California for that same time period, according to that state's AG's office. In Washington, the company sold nearly 12,000 units beginning in 2005, that AG's statement said. Worldwide, more than 2 million women had been implanted with these mesh products, the California statement noted.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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Get Ready for Medical Innovation on CBS

"This is the revolution, Dr. Wallace." Medical device revolution?

Chris Newmarker

What if you could just cut through all the healthcare industry red tape and find a Silicon Valley tech billionaire willing to fund your wildest medical device industry innovation dreams?

Well, good luck on that. But until then, you can always bust open a bag of chips, pour a cold drink and watch CBS' new "Pure Genius" television series, expected out this fall. 

The series is about a tech billionaire named James Bell, played by Augustus Prew, who is willing to use his money to cut through the red tape and use technology to solve seemingly impossible medical cases--and the somewhat skeptical Dr. Walter Wallace, played by Dermot Mulroney, who ends up joining him on the quest. 

"Gadgets and gizmos have been around the medical industry forever," Wallace complains. 

"This is the revolution, Dr. Wallace," Bell says. 

Watching the trailer, the premise seems like a bit of a head-scratcher at times. (Isn't Bell going to get sued for malpractice, walking into all these patient rooms and promising cures when he has no idea yet how he's going to do it? Maybe that's a future episode.) But the futuristic technology in the trailer is actually stuff that is already out there, advances that Qmed has extensively covered: adhesive wearable health monitors, 3-D printed models to help a surgeon prepare, brain-to-brain communication

Check out the trailer: 

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

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

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Varian Has Big Plans for Cancer Treatment

Varian Medical Systems' decision to spin off it imaging components business shows that it wants to be a global cancer firm, not just a radiation oncology company.

Arundhati Parmar

Varian which way
(Image courtesy of  istock.com user ryasick)

Varian Medical Systems, a maker of radiation oncology equipment, announced this week that it will spin off its imaging components business as a separate company through a tax-free distribution to shareholders.

The transaction is expected to be complete by the end of the year when the business, which employs about 1300, will become independent with headquarters in Salt Lake City, UT.

The medical device industry has seen a slew of mergers in recent years. But medtech companies have also been engaged in pruning their portfolios in the last few years to adjust to a rapidly changing healthcare industry. Some big divestments include Johnson & Johnson shedding its Cordis business--the unit that pioneered the drug eluting stent category-- that Cardinal Health scooped up for nearly $2 billion last year.

More recently, Smith & Nephew shed its gynecology business, which Medtronic is buying for about $350 million.

For Varian, the spin out is more about increasing its focus on being a cancer treatment company.

"The spin-off will create two strong, independent companies," said Dow Wilson, CEO of Varian Medical Systems, in a statement.  "It will enable Varian to focus on expanding its position as a global cancer company with leading technology and services. The objectives and growth strategies of our imaging components and oncology businesses are now taking them in different directions."

Varian Imaging Components makes x-ray tubes, flat panel detectors, connectors, and accessories for imaging. It also functions as a supplier of workstations and software for computer-aided diagnostics and image processing.  

This business, which generates about $575 million in revenue had lately become a drag on the rest of the business, according to Brandon Henry, an analyst with RBC Capital Markets.

In a research note published Monday, he wrote: "Imaging Components has recently struggled due to: 1) a significant decline in security and inspection revenues as customers, particularly in oil-based economies, slowed spending; 2) major flat panel pricing declines, as the company was forced to lower pricing to retain market share amid currency moves, which benefited [Varian's] overseas competitors; 3) a large flat panel customer (Carestream) deciding to in-source manufacturing; and 4) Toshiba reducing inventory in tubes after announcing plans to sell its Medical Systems unit to Canon."

Henry applauded the decision to jettison the business, noting that spinning of a non-core business like Imaging Components makes strategic sense.

"...we believe management is looking to redefine [Varian] as more of a cancer company versus just a radiation oncology company."

However, this may not mean that Varian is planning big deals.

"We do not expect any transformational M&A, as management likes to keep a relatively conservative balance sheet." Henry said.

Still, tuck-in M&As may be able to provide more revenue growth to the overall company than in the past, he said.

One area that Henry believe may make sense for Varian to do some M&A: radioembolization ablative therapy.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Arundhati Parmar is a senior editor at UBM.

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Is FDA Failing on OB-GYN Device Approvals?

A new study recommends "more rigorous regulatory standards for the approval and postapproval tracking requirements for high-risk devices."

Nancy Crotti

FDA has approved devices for obstetrics and gynecology without sufficient data, according to a study by Northwestern University.

Of the 18 high-risk OB-GYN devices approved from January 2000 to December 2015, 42% passed muster on the basis of nonrandomized controlled trials, according to research published in Obstetrics & Gynecology. Medical residents from Northwestern University conducted the study. The approved devices included highly controversial pelvic meshes, laparoscopic morcellators, and the Essure birth control device.

FDA spokeswoman Deborah Kotz declined to discuss the study: "As a general policy, we do not comment on individual studies but consider them as part of the medical literature in terms of how FDA evaluates the safety profile of medical devices."

Approved in 2002, Essure has been linked to five patient deaths,  as well as to metal toxicity, potentially-lifelong autoimmune problems, unintended pregnancy, headaches, and fatigue. The agency gave the device a PMA  "with insufficient long-term evidence and postmarket surveillance requirements," the university statement says. Essure was developed by Conceptus and is now marketed by Bayer.

Transvaginal mesh devices used to treat pelvic organ prolapse have been the subject of numerous lawsuits. In January 2016, FDA ordered manufacturersof pelvic mesh devices still on the market to submit PMAs, which require data from a pivotal study.

Most of the devices were approved for endometrial ablation, (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days), the study noted.

FDA approved four of the deviceseven though they failed to demonstrate efficacy in clinical trials. Six were not required to undergo post-market studies of ongoing safety. Three devices were eventually withdrawn from the market after approval. Of those three, two were not reviewed by physician experts on the FDA's obstetrics and gynecology advisory committee. The other was reviewed but not recommended for approval by the committee.

"We looked at the class of devices with the highest potential risk to patients--the devices that had to go through the most rigorous pre-market approval process," said senior author Steve Xu, MD, a resident in derrmatology, in a university statement. "Despite this being the most stringent pathway, and despite the fact that we've had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses."

The study recommended expanding FDA's OB-GYN advisory panel. The authors also suggested that all clinicians learn how FDA regulation works and take a more active role collecting and reporting data about the complications and unintended outcomes that result from devices.

They're also concerned about the possibility that Congress will allow FDA to approve devices with less stringent controls. The 21st Century Cures Act, passed by the U.S. House of Representatives in 2015 and now under consideration by the Senate, would reduce medical device regulation.

"There are provisions that would broaden the definition of the 'valid scientific evidence' manufacturers need in order to prove medical benefit. Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective," said study first author Jessica Walter, MD, an OB-GYN resident, in the statement. 

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed.

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