MedAutonomic Has Successful Implant of Phoenix

Pixabay MedAutonomic Has Successful Implant of Phoenix

MedAutonomic has made significant progress with its brain neuromodulation technology. The Silicon Valley and Venice, Italy-based company said it had successfully implanted the Phoenix device into the stomach wall of a human through a digestive endoscopic procedure.

The device sends signals to the brain (the limbic system)to reset an imbalance in the Autonomic Nervous System with the aim to treat functional diseases such as type-2 diabetes, hypertension, and gastroesophageal reflux disease (GERD). The company said Phoenix is able to harvest energy from the body, so it can remain in the stomach wall without the need of a battery.

Our initial results of the first human implant of the Phoenix represent an important milestone for our company, said MedAutonomic president Dr. Valerio Cigaina in a release. “The outpatient procedure using a gastric endoscope has been perfected, and we are able to implant our device without surgery in less than ten minutes. We are pleased to be the first to insert a diagnostic and/or therapeutic device in the gastric wall in a minimally invasive way, with the device perfectly tolerated over the long term. The Phoenix is sending a signal to the brain, which is confirmed by heart rate variability.

Phoenix is a bioelectric medicine, which is on the cusp of taking off. Companies such as SetPoint Medical, Biosig, ElectroCore, and Stimwave are prevalent in the space.

But the Bioelectronics market really got a huge jolt of attention when GlaxoSmithKline (GSK) and Google's Verily Life Sciences, an Alphabet company, teamed to form Galvani Bioelectronics. The two companies plan to invest about $700 million over seven years.

7 Key Events That Solidified the Liquid Biopsy Market

<p><strong>Rise of the Liquid Biopsy Market</strong></p><p>Liquid Biopsies are non-invasive alternatives to surgical biopsies and allow physicians to discover information about a disease or condition through a liquid sample. The market has seen tremendous growth over the past few years with several memorable events that include, blockbuster deals, mammoth financings, and significant FDA approvals. Here are the key events in recent history that have helped solidify the Liquid Biopsy market.</p>

Single-Touch Labeling: The Answer to EU MDR?

Single-Touch Labeling: The Answer to EU MDR?
Image courtesy of PRISYM ID

The journey to adoption of Europe’s Medical Device Regulations (EU MDR) begins with understanding what’s changing—and when—and then establishing whether current systems and processes are sufficient to satisfy the new regulatory requirements. With the new rules mandating the redesign of every single label being used in supply to the EU market, it appears unlikely that medical device companies will be able to rely on long-term legacy labeling systems. However, with new regulations in other key markets also coming further down the line, organizations need to make sure that future systems have in-built agility to respond to change as and when it happens.

EU MDR

The labeling changes mandated by EU MDR are likely to have far-reaching implications for most medical device companies. The timetable for change and the scale of the task ahead leave little room for comfort. The clock is ticking toward May 2020, when the introduction of the European Databank on Medical Devices (EUDAMED) will mean companies could be prevented from registering or re-registering their products if they don’t address associated labeling challenges ahead of time. Failure to do so could mean companies cannot market their products in Europe. Furthermore, imminent changes to regulation in key markets outside of the EU and the United States mean that companies must rethink their labeling operations or risk route-to-market or supply-chain barriers on a global scale.

The purpose of the EUDAMED is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. The European Commission has stated the importance of the EUDAMED for the functioning of the MDR and the In Vitro Diagnostic Medical Device Regulation (IVDR) in Europe. The database, which consists of seven other databases (Economic Operators, Devices, UDI, Certificates, Clinical Studies and Performance Studies, Vigilance Data, and Market Surveillance), will be accessible to competent authorities, notified bodies, industry, and the general public.

Facing a task of such magnitude, the question arises as to how organizations can achieve effective and safe change within the remaining time frame.

New Labeling Requirements

Chapter III of EU MDR, Article 23.1, stipulates that every device must be accompanied by information that identifies the device, its manufacturer, and any relevant safety/performance information. This information may appear on the device, the packaging, and the IFU. Furthermore, if the manufacturer has a Website, the information must now also be made available—and kept up to date—online.

These basic requirements, which will be rigorously enforced from May 2020, mean that, more than ever before, companies must be in control of the data they are using for their products. Historically, departments in many organizations have often maintained their own product data because they do not trust other sources. This has led to the use of multiple systems, each operating in isolation and capturing information in self-serving silos. In the example of one of the world’s largest medical device manufacturers, the organization was running no less than 30 separate labeling systems over 20 plants and 150 production lines. This approach is fraught with risk and no longer acceptable. Moreover, this traditional approach makes the cost of making a global label change very expensive.

Single-Touch Strategy

Companies need to develop a culture of data integration and sharing. Moreover, they need to put systems in place that establish a “single source of the truth,” allowing data to be pulled from disparate systems, interfaced as a single view, and shared across the organization. The single-source approach can eradicate data duplication, inconsistencies, and costly human error. What’s more, it can significantly reduce the complexity and risks of MDR compliance.

The most progressive organizations, such as the aforementioned manufacturer, have recognized this: they know that their current labeling infrastructure is unfit for purpose and that they need to safeguard against future regulations. In addition, with major providers like Microsoft and Oracle etc. ending their support for several operating systems and databases by 2023, these companies have realized that their labeling solutions could potentially be sitting on unvalidated platforms that expose them to regulatory risk.

As a result, a growing number of medical device companies are adopting a single-touch strategy where they undergo a wholesale redesign of their global labeling processes and technology infrastructure all at once, rather than repeating the cost and disruption of additional implementations further down the line. Attack once and reduce the upcoming 2- to 4-year project cycle into 12 months.

An effective single-touch strategy can streamline processes and reduce the cost of global change by as much as 90%. For medical device companies facing a steady barrage of complex, impactful regulatory changes, the deployment of data-led labeling systems can ensure they only need to touch their labels once, whilst meeting their impending deadlines safely and effectively. The approach, which accelerates speed to market and reduces the risk of non-compliance through the efficient use of automation, also allows companies to future-proof their business as regulations and country requirements evolve over time.

360° Visibility

The importance of selecting a labeling solution that can adapt to a changing world cannot be overstated. The best systems give manufacturers 360° visibility of all their master data assets. Moreover, by taking a data-led approach and ensuring information is available wherever and whenever it is needed, they ensure the core components of end-to-end label lifecycle management—label design, workflow, inspection capabilities, and audit control—are fully integrated and accessible across the global organization, both today and in the future.

XACT Brings in Funding and CE Mark for Robotics Navigation System

Pixabay XACT Brings in Funding and CE Mark for Robotics Navigation System

XACT Robotics has received CE mark for its robotics navigation steering system. On top of that, the Caesarea, Israel-based company has raised about $5 million in a series C round. How’s that for being efficient?

The company said the funds will mainly be used for the launch and operation of seven Centers of Excellence in the US, Europe, and Israel, where the company expects that hundreds of clinical procedures will be conducted within the next 12 months with the XACT robotic navigation and steering system.

The XACT robotics system is currently approved and being used for CT-guided percutaneous procedures in the abdomen. Later this year, the system's application is expected to be expanded for use in additional clinical centers and with other imaging modalities, such as Cone-Beam CT and Fluoroscopy, and for additional indications, including spinal and lung procedures.

"The CE Mark approval is a key achievement for XACT and an important milestone towards entering the European market," Chen Levin, CEO of XACT Robotics, said in a release. "In parallel, the closing of our latest financial round will enable us to initiate the launch of our robotics system next year, while continuing to develop additional features for the system. Our Center of Excellence in Hadassah Medical Center is the first of seven centers that we plan to launch by the end of this year in leading medical centers in the US, Europe and Israel. The goal of these centers is to gain additional clinical experience and to serve as the primary training centers towards the full product launch of the XACT system planned for 2019."

The world of surgical robotics is growing rather quickly and is taking several twists and turns. For years, Intuitive Surgical has dominated the field. During its most recent earnings call, the Sunnyvale, CA-based company said global procedure growth was about 18% in 2Q18 compared with 2Q17, driven by the acceptance of da Vinci in general surgery in the US, growth internationally, and appreciation for the company's platform.

However, competition is coming.

TransEnterix, a company that had a pretty challenging 2016, actually rebounded and received FDA clearance for its Senhance system in 2017. The clearance was a historic moment in the surgical robotics market, because it is the first new market entrant in the field of abdominal since Intuitive’s da Vinci received an FDA nod in 2000. TransEnterix acquired the Senhance, which was originally called the ALF-X System in 2015.

Even Google’s Verily Life Science is getting in on the act and has teamed up with Johnson & Johnson’s Ethicon to form Verb to develop an artificial intelligence-focused surgical robotics platform.

But not all companies are moving at a rapid pace in the space. In February, Medtronic reaffirmed plans it originally announced in February, to delay its surgical robotics platform for about a year. The Dublin-based company’s system could now come sometime in 2019.

Can LivaNova Succeed Where Others Have Failed in HF?

Courtesy of LivaNova Can LivaNova Succeed Where Others Have Failed in HF?

LivaNova continues to live up to the promise it made to shareholders that it would focus more on its neuromodulation and cardiac surgery businesses. Through the VITARIA neuromodulation technology, the London and Houston, TX-based firm is fulfilling that promise with one device and one fell swoop.

“We clearly talk about ourselves as a company focused on the head and the heart,” Edward Andrle, LivaNova’s General Manager of Neuromodulation, told MD+DI. “What’s interesting about this therapy is that it is a neuromodulation therapy. But the indication that we’re treating is for heart failure.” 

LivaNova said it was launching the Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction (ANTHEM-HFrEF) Pivotal Study. The study will enroll up to 800 patients.

“Patients’ autonomic nervous system tend to get out of balance when they have heart failure,” Andrle said. “What we’re doing in essence with vagus nerve stimulation is trying to bring the sympathetic and parasympathetic systems back into balance.”

The VITARIA System received CE mark in 2015 when it was owned by Cyberonics, a company that merged with Sorin in 2015 to form LivaNova. However, the company hasn’t commercialized VITARIA.

“We haven’t commercialized the therapy in Europe yet, because we felt it was important to develop the clinical evidence to support the efficacy of the therapy,” he said.

Andrle declined to give a timeline on when the company would submit to FDA. He noted that it would be "several years out."

The therapy may be the first implantable active neurostimulation system for the treatment of advanced heart failure, if the study demonstrates statistically and clinically meaningful improvements in pre-specified endpoints related to heart failure symptom improvement, hospitalization and survival.

There have been other attempts such as Boston Scientific through the Nectar HF Trial. However, the Marlborough, MA-based company’s trial failed to meet its 6-month efficacy endpoint in 2014. In addition, Yehud, Israel-based BioControl Medical failed to show patients with chronic HF who were treated with its CardioFit vagal nerve stimulation system did not experience a reduction in death from any cause or HF events in the INOVATE trial, according to data presented at the American College of Cardiology Scientific Session in 2016.

“Patients with advanced heart failure continue to need additional and complementary therapy options, since drug treatment alone has slowed but not stopped heart failure progression,” said Dr. Ron M. Oren, Heart Failure Cardiologist and Lead Investigator for the Study at the Heart and Vascular Institute in Cedar Rapids, IA, said in a release. “We are pleased to participate in this important study to critically evaluate the safety and efficacy of Autonomic Regulation Therapy delivered by the VITARIA System.”

A Streamlined Vision

The path toward LivaNova restructuring began in September of 2017. LivaNova decided to seek out strategic options for its cardiac rhythm and management (CRM) unit, which brought in about $249.1 million in net sales in 2016. About two months after mulling over a potential sale of the CRM business, Shanghai-based Microport stepped in to acquire the unit for $190 million in cash.

Two weeks after the divestiture of the CRM unit, LivaNova picked up ImThera for $225 million. The deal would go toward building up LivaNova’s neuromodulation offerings. San Diego, CA-based ImThera has developed an implantable device to stimulate multiple tongue muscles via the hypoglossal nerve, which opens the airway while a patient is sleeping.

Medtronic Will Study TAVR in Low-Risk Patients with Bicuspid Valves

Medtronic plc Medtronic Will Study TAVR in Low-Risk Patients with Bicuspid Valves

Indication is to the transcatheter aortic valve replacement (TAVR) market as location is to the real estate business.

Although TAVR already represents a $3 billion market globally, the leading TAVR companies say the currently approved indications barely scratche the surface in terms of the true growth potential of the space. This week, just ahead of the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Diego, Medtronic announced that FDA has given the go-ahead for a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. 

The Dublin, Ireland-based company also received FDA approval for revised commercial labeling for the CoreValve Evolut TAVR system that removed a precaution for the treatment of bicuspid severe aortic stenosis patients deemed at intermediate or greater risk for surgical aortic valve replacement (SAVR).

Bicuspid valve patients are born with two aortic valve leaflets instead of the more common three leaflets (tricuspid). Medtronic noted that 1 in 5 patients undergoing SAVR is a bicuspid valve patient.

“Real-world data suggests that TAVR with the self-expanding Evolut can be a suitable treatment option for many patients with bicuspid aortic valve disease,” said Jeffrey Popma, MD, director of interventional cardiology at the Beth Israel Deaconess Medical Center in Boston, MA. “In fact, data from the TVT Registry has shown near-parity in certain outcomes between bicuspid and tricuspid patients using the Evolut self-expanding platform.”

Medtronic is studying bicuspid patients within a separate single-arm study of the low-risk TAVR trial. In the United States,  treatment with bicuspid aortic valves in patients who are at low risk of surgical mortality is investigational use only.

“As a leader in heart valve solutions, this label revision enables us to provide proactive training and education on procedural TAVR sizing and placement in this patient population,” said Pieter Kappetein, MD, vice president of medical affairs for Medtronic's structural heart business. “The bicuspid study, in addition to new studies on TAVR efficiencies and leaflet mobility, will provide important insights as we look to further refine TAVR therapy.”

Navigating the World of Digital Health Products

Navigating the World of Digital Health Products
Pixabay

A presentation at MD&M Minneapolis aims to help medical device manufacturers and newcomers alike overcome the challenges of designing digital devices.

“Scale and cost and prevalence of consumer-oriented technology like Wi fi and Bluetooth and cell phones have made possible a whole new category of health-related devices,” Bill Betten, president of Betten Systems Solutions LLC, told MD+DI. He will discuss digital health products in a talk on November 1 at MD&M Minneapolis, “Case Study: Overcoming Digital Health Product Development.” The session will feature a case study that shows the development of a device that uses commercial sensor technology, from design to a practical therapy, describing the challenges along the way.

MD+DI spoke with Betten to get his thoughts on these emerging technologies.

MD+DI: Please explain what products fall into the digital health category.

Betten: Digital health products include wireless medical devices, mobile medical apps that are regulated by FDA, health IT, medical device data systems, and software.

Since this definition kind of came from FDA, there’s a heavy emphasis on regulated medical devices that are used to diagnose or treat medical conditions. But general wellness devices such as fitness trackers can be part of this environment as well. So, it’s a broad category that spills over into wellness, as well as traditional medical devices with connectivity.

MD+DI: What are some of biggest challenges faced during the development of digital health products?

Betten: The biggest challenge is not so much the technology, unless you’re really doing something innovative and creative like identifying cancer from a blood sample or a breast sample. It is much more about the regulatory environment, the reimbursement environment, and just the way we practice medicine. The challenge the industry is facing is the organizational inertia.

I like to say that there are corporate antibodies that resist change. Change is sometimes viewed as infection, and there’s a lot of pushback on that. The good news is that there are signs of change in the movement to value-based healthcare, in reimbursement changes, and regulatory flexibility.

MD+DI: Are some less challenging than others?

Betten: Class I medical devices such as thermometers and fitness and wellness apps can be. But even with Class I devices, you have to be very careful about what you say is the product’s intended use.

MD+DI: What types of mistakes have been made in the past when developing digital health products?

Betten: I think you have to be very specific about the intended use. For example, there was a class action lawsuit filed in 2016 (and still ongoing) against Fit Bit, claiming that it had deceptive and misleading representation about its heart rate monitor. You have to be very careful about what you say the product will do. If it’s a regulated medical device, the instructions for use, the intended use, will be very clear. That’s one thing the medical device companies are trained to do is be very specific about its intended use. That same rigor does not apply to consumer-oriented devices. Apple’s new watch, for example, has a heart-monitoring and ECG capability that they submitted to FDA for clearance, hence making it a medical device suitable for the uses that they claim.

MD+DI: How big a part of the entire medical device industry is the digital health products category?

Betten: The problem is how you define it. For example, are fitness trackers part of that? But it’s very clear the growth rate in that space is very high. It’s certainly in the 10%+ range of the overall healthcare space and it’s growing rather dramatically and rapidly and will continue to do so.

MD+DI: Who should attend your session, and why?

Betten: I think it’s good for the traditional medical device development folks to help make them aware of some of things that are bleeding over from the consumer space.

Also, people in the consumer space should attend. People who want to develop an app, to know and understand, particularly the closer to they get to the FDA line, to being regulated, the clearer they must be about what they’re doing. It’s a good high-level introduction to the medical device industry.

MD+DI: What do you hope they learn from your session?

Betten: A better understanding and appreciation of the promise of digital health technology and the challenges that you face when bringing a product into that space. This will not be a focused talk on regulatory, reimbursement, or even cyber security, but it will be an overview of digital health with a specific case study of a product that has been brought to market. We hope there’ll be enough in there for everybody.

Betten’s presentation, “Case Study: Overcoming Digital Health Product Development Challenges,” will be held at MD&M Minneapolis on Thursday, November 1, from 11:00 to 11:45 a.m.

Breast Implant Study Should Be Taken with a Grain of Salt, FDA Says

Breast Implant Study Should Be Taken with a Grain of Salt, FDA Says

A study linking silicone gel-filled breast implants with several rare diseases should be viewed with caution, according to FDA.

The authors of the study, published last week in the Annals of Surgery, say they looked at data from nearly 100,000 breast implant procedures gleaned from FDA-mandated postmarket studies for implants made by Johnson & Johnson's Mentor business, and by Allergan. The analysis showed that silicone implants are associated with higher rates of  Sjögren syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma.

The researchers reported that 56% of the implants included in the database were silicone for primary augmentation. They also found that, in the short term, rupture rate is higher for saline-filled implants compared to silicone gel-filled implants (2.5% vs. 0.5%), but capsular contracture, a condition that develops when internal scar tissue forms a tight or constricting capsule around the implant, contracting it until it becomes misshapen and hard, was higher for silicone (5.0% vs. 2.8%). At 7 years, the reoperation rate is 11.7% for primary augmentation and 25% for primary/revision reconstruction. Capsular contracture occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations.

"Silicone implants are associated with an increased risk of certain rare harms," the authors concluded. "Associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants."

FDA published an editorial response alongside the study, pointing to "significant shortcomings" with the study's methodology, how the data is presented, and its conclusions. The agency noted inconsistencies in the data and potential sources of bias.

Breast implants have been a source of contention between patient advocacy groups, industry, and FDA for decades. Implants were banned from the U.S. market from 1992 to 2006, and the devices have been the cause of an overwhelming number of lawsuits. Last year, a California woman sued Johnson & Johnson and two of its subsidiaries, claiming that leaking silicone breast implants caused muscle pain and nausea.

When FDA lifted the 14-year moratorium on silicone breast implants in 2006, each manufacturer (J&J's Mentor, and Allergan) was required to conduct six post-approval studies to further characterize the safety and effectiveness of their breast implants and to answer additional scientific questions about the long-term safety of breast implants that the premarket clinical trials were not designed to answer.

As part of these post-approval studies, FDA collected data from the studies totaling nearly 100,000 patients. FDA previously reported the results of these studies, which were the same studied that formed the basis for the recently published assessment. In 2011 the agency identified a possible link between breast implants (both silicone and saline-filled) and anaplastic large cell lymphoma.

"We understand that there are concerned patients with breast implants who are experiencing a range of symptoms that may or may not be related to their breast implants," said Binita Ashar, MD, a general surgeon and the director of the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health. "We take these concerns seriously and are committed to continuing to work with patient groups, surgeons, and scientists to further assess this issue. While the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases, we respect studies like the ones published in Annals of Surgery by our peers. These studies contribute to our discourse on this topic, but more evaluation is required."

In the editorial, Ashar said the authors of the current study failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, as well as confounding and other potential sources of bias. That's why FDA says the study's conclusions should be viewed with caution. She also noted that the limitations of the report highlight the need for better postmarket evidence generation, including active surveillance capabilities.

Ashar said the agency is working with multiple stakeholders to develop a National Breast Implant Registry (NBIR) to provide a platform for evaluating real-world data on the safety and performance of breast implants.

"We have heard from patients who are concerned that their implants may be connected to other health conditions, like chronic fatigue, cognitive issues, and muscle pain," Ahsar said. "While the FDA does not have evidence suggesting breast implants are associated with these conditions, information from NBIR may help us identify risk factors for complications, such as a patient’s own medical history, the specific type of operation, the type of implant used, and concomitant use of other medical devices. Greater information-gathering from a registry like NBIR will add helpful information to the FDA’s already extensive review of our own medical device reports, review of medical literature, assessment of post-approval studies, and meetings with patients."

Finding Lung Cancer Outside the Airways Just Got Easier

Broncus Medical Inc. Finding Lung Cancer Outside the Airways Just Got Easier

Diagnosing solitary lung tumors located outside of a patient's main airways has long been a challenge, but evidence is building around a technology designed to improve access to such tumors.

According to data unveiled this week at the European Respiratory Society International Congress in Paris, Broncus Medical's Archimedes virtual bronchoscopy navigation system helped to more than double the diagnostic yield for nodules with negative bronchus sign or an airway leading to the nodule.

The six-year-old, San Jose, CA-based company said the Archimedes System is the only system of its kind offering real-time virtual bronchoscopic navigation with embedded intra-procedure fused-fluoroscopic guidance, providing a 3D view and access to nodules anywhere in the lung.

“It has been historically challenging to accurately diagnose solitary lung tumors located outside of the main airways, especially when they are small, with diagnosis rates only in the 30% range,” said Felix Herth, lead author of the study and chairman of the Department of Pneumology and Critical Care Medicine at Thoraxklinik University of Heidelberg, Germany. “By pre-plotting a path to the nodule that avoids the vasculature and navigating through the lung anatomy with three-dimensional, real-time, fluoroscopic guidance, the Archimedes System demonstrated in this study that it aided in more than doubling the diagnostic yield of these challenging tumors to 77.8%, thereby significantly improving existing guided transbronchial biopsy.”

The multi-center study was conducted at five clinical sites and encompassed 18 single pulmonary nodules (SPNs) lacking an airway path for biopsy. The Archimedes System was used for bronchoscopic transparenchymal nodule access (BTPNA) to select an avascular path to a point of entry on the airway wall and to provide real-time navigation for hole creation, dilation, and biopsy.

Using the Archimedes System, overall diagnostic yield was 77.8% on SPNs with a mean major axis of 18.1±6.8mm, without major complications or pneumothorax. Lesions smaller than 20.0mm had a diagnostic yield of 77.8%, with a mean major axis of 12.3 ± 4.2mm and were a mean distance to the pleura of 21.3 ± 13.2mm, while lesions that were 20.0mm or larger also had a diagnostic yield of 77.8%, with a mean major axis of 23.8 ± 2.5mm and a mean distance to the pleura of 19.0 ± 18.7mm.

These results demonstrate that combining virtual bronchoscopic navigation with fused fluoroscopy in the Archimedes System with bronchoscopy allows the bronchoscopist access to nodules located anywhere in the lungs. Prior to the Archimedes System, small nodules without a bronchus sign would have most commonly required a more invasive trans-thoracic approach requiring a puncture through the chest wall to access the nodule, Broncus said.

The company is currently enrolling at least 100 patients in a larger study of the Archimedes System, which is expected to be completed by the end of the year. 

“The evidence is building that BTPNA under the guidance of our Archimedes System can navigate to and access nodules anywhere in the lung without major complications,” said Broncus President Henky Wibowo. “We are demonstrating that we can address a critical need in lung cancer by enabling accurate diagnosis of nodules, regardless of the presence of a CT bronchus sign, improving overall lung cancer diagnosis and treatment.”

Earlier this year, Medtronic and Philips unveiled the jointly developed LungGPS patient management platform. Part of the genesis of that partnership was the recognition that clinicians need better tools to help transform lung cancer from a death sentence to a more manageable disease.

Another company making strides in the way lung cancer is detected include Salt Lake City, UT-based ProLung , which has a radiation-free test intended for use at the front end of lung cancer screening and possibly as an adjunct to low-dose CT screening. Other companies, like Melbourne, Australia-based 4Dx, are working to improve lung function imaging.

Venture Heat Warms up Wearables with New FDA Nod

Pixabay Venture Heat Warms up Wearables with New FDA Nod

On Monday, Los Alamitos, CA-based Venture Heat said it had received FDA clearance for its Infrared Heat Therapy Pain Relief using Far infrared Rays (FIR). FIR heat therapy is a type of low-energy therapy that takes advantage of heat generated by waves of energy from the far end of the infrared spectrum.

“It’s a lot easier for the consumer to use this particular design,” Eddie Chen, president of Venture Heat, told MD+DI. “Using the product is similar to using the compression wraps. We wanted it to be simple to use and mobile.”

The wraps are made out of flexible neoprene rubber and lined with soft fleece for maximum comfort. The 3D tailoring not only helps the wraps fit better, but also ensures heat is delivered directly to painful areas. Typically, wraps are used for relief from deep tissue and stiff muscle pains, sports injuries, back and neck pain, surgical recovery, sciatica, arthritis and more. Heat therapy decreases joint stiffness, relieves muscle spasms, reduces inflammation and improves blood flow, leading to nutrients and oxygen reaching the affected area for faster healing.

The company said that most heat-therapy devices in the market use high-voltage energy sources between 100-120 volts, which can be both dangerous and expensive. Venture Heat’s products safely use low 12-V DC for plugin use at home and a 12-V Lithium Ion battery for use on the go.