New Developments in FDA Regulation of AI
CONCLUSION
On the whole, FDA seems very enthusiastic about the possibilities for AI to improve healthcare. That’s gratifying to see. While progress in the development of a new regulatory approach is slow, that’s also not all bad. It would be worse in many ways for FDA to act precipitously. These are complicated issues, and it will take time to develop an appropriate approach, in part because it will take time for FDA to acquire enough expertise. And most likely, whatever new approach we come up with will require new statutory authority. That said, it is incumben...
Source: MDDI - April 10, 2020 Category: Medical Devices Authors: Bradley Merrill Thompson Tags: Regulatory and Compliance Source Type: news
Viveve Could Hit Reset Button After Failing to Meet Endpoints in Trial
Viveve Medical has hit a snag after it failed to meet the endpoints in a clinical trial for technology to improve the sexual function in women following vaginal childbirth.
The Englewood, CO-based company said as a result of the results and impact from the COVID-19 pandemic that it was evaluating strategic alternatives, as well as actively assessing its current organization and cost structure.
Viveve is developing a Cryogen-cooled Monopolar Radiofrequency (CMRF) technology that can treat vaginal laxity. The technology delivers RF energy deeply into soft tissues – which results in neocollagenesis, or a str...
Source: MDDI - April 9, 2020 Category: Medical Devices Tags: Business Source Type: news
Supplier Stories for the Week of April 5
(Source: MDDI)
Source: MDDI - April 9, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news
How to Service Essential Medical Equipment During a Pandemic
The global coronavirus pandemic and subsequent social distancing recommendations and shelter-in-place mandates have impacted everything from how we interact with our friends and family members to how we do business. While millions of people and companies have turned to platforms like Zoom and Microsoft Teams to conduct business from home, there are still essential service workers that simply cannot do their job remotely, like the people tasked with maintaining and repairing critical medical equipment, for example.
MD+DI spoke with Stacey Epstein, chief marketing and customer ...
Source: MDDI - April 9, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Source Type: news
Organovo Says No to Tarveda Merger
Organovo Holdings said it has terminated its merger agreement with Tarveda Therapeutics. The San Diego, CA-based company originally submitted the proposal to merge with Tarveda Therapeutics late last year.
Watertown, MA-based Tarveda is a clinical-stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates.
The merger proposal, which would have been an all-stock transaction, was voted down during a recent special meeting of stockholders. If the merger had gone through the combined company would have operated under the ...
Source: MDDI - April 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
How Continuous Glucose Monitoring Systems Are Joining the COVID-19 Fight
In response to healthcare workers asking for safer ways to monitor hospitalized diabetes patients with COVID-19, FDA is allowing both Dexcom and Abbott to supply continuous glucose monitoring (CGM) systems for use in the hospital setting during the pandemic. This allows frontline healthcare workers in hospitals to remotely monitor patients with diabetes in order to minimize exposure to the virus that causes COVID-19 and preserve use of personal protective equipment (PPE).
Abbott said it has partnered with the American Diabetes Association, Insulin for Life USA, and the Diabetes Disaster Response Coa...
Source: MDDI - April 8, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Source Type: news
Rushing Supplies to the COVID-19 Forefront
Healthcare providers responding to the COVID-19 crisis need significant amounts of diagnostic testing supplies, protective personal equipment, respiratory treatment equipment and supplies, and a host of other items, according to an April 2020 report from the U.S. Department of Health and Human Services. And as treatment centers have emerged in nontraditional locations to back up hospitals, these supplies are needed in some unique areas.
The Global Healthcare Exchange (GHX) has set up the COVID-19 Information Center to help both healthcare organizations and manufacturers of medical supplies manage any shortages and navigate...
Source: MDDI - April 8, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news
GenMark Diagnostics Sees 80% Revenue Boost in First Quarter
COVID-19 has been tough on companies across many different industries but the current pandemic has shined a spotlight on what was previously a quieter corner of medtech: molecular diagnostics. And for the companies in that sector that have stepped up and responded to the crisis with tests to detect SARS-CoV-2 test, the virus that causes COVID-19, those efforts are paying off.
On Tuesday, Carlsbad, CA-based GenMark Diagnostics, a provider of automated, multiplex molecular diagnostic testing systems, preannounced first-quarter revenue of about $38.7 million, representing an increase of abo...
Source: MDDI - April 8, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Collaboration Uses AI to Expand Medical Imaging Services
Nanox Imaging has struck a partnership with Qure.ai that could have an impact on medical imaging.
The Neve Ilan, Israel-based company said it will integrate Qure.ai’s diagnostic solution into the Nanox.CLOUD platform. Nanox said it is working to expand the range of medical imaging services it intends to provide to improve the accessibility and affordability of early-detection services.
The Nanox.CLOUD is designed to provide an end-to-end medical imaging service, including services such as image repository, radiologist matching, online and offline diagnostics review and annotation, connectivity to diagnost...
Source: MDDI - April 7, 2020 Category: Medical Devices Authors: Omar Ford Tags: Software Business Source Type: news
Boston Scientific Recalls Angiographic Catheters Due to Injuries
At least nine people have been injured by a faulty cateter tip on Boston Scientific's Imager II 5F Angiographic Catheters, FDA reported this week. The company initiated a recall of the device in February that includes 6,130 of the catheters distributed between July 16, 2018 and Nov. 26, 2019. Click here for a full list of affected lot numbers.
The catheters are used to provide a pathway to deliver contrast agents to blood vessels. FDA said there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. According to the recall notice from FDA, use of the a...
Source: MDDI - April 7, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Allurion Files for PMA Submission of Elipse Gastric Balloon
Allurion Technologies is one step closer to having its Elipse gastric balloon enter the U.S. market. The Natick, MA-based company announced the PMA submission of the device early Tuesday.
The submission comes hot on the heels of Allurion raising $34 million in new funding through a securities financing and a growth capital term loan. Allurion also announced the hiring of Joyce Johnson as VP, Regulatory Affairs and Quality Assurance.
“Joyce comes to Allurion at an opportune and exciting time as we work towards receiving US regulatory approval from the FDA for the Elipse Balloon,†said Sha...
Source: MDDI - April 7, 2020 Category: Medical Devices Authors: Omar Ford Tags: Implants Regulatory and Compliance Source Type: news
Luminex Gains EUA for Diagnostics as Demand for COVID-19 Tests Soars
Luminex can be added to the list of companies that have received Emergency Use Authorization (EUA) for a diagnostic to address the coronavirus (COVID-19) pandemic.
The Austin, TX-based firm was granted the designation for the Aries SARS-CoV-2 Assay for the rapid detection of the virus that causes COVID-19. The assay runs on the Aries System, which is cleared by FDA and has the capability of running up to 144 tests per day.
Recently Luminex received another EUA in addition to Medical Device Authorization for importation or sale for Health Canada for the NxTAG CoV Extended Panel. The company said the panel is a h...
Source: MDDI - April 7, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
Non-surgical Device for BPH Wins De Novo from FDA
FDA has granted de novo classification to a non-surgical device for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). The iTind device was developed by Or Akiva, Israel-based Medi-Tate. However, Olympus holds the exclusive right to distribute iTind in the U.S.
Here’s how iTind works. The flexible three-strut nitinol device can be placed during an in-office procedure. It expands over five days to create channels that allow urine to flow and reshape the prostate.
In a release, Nacho Abia, COO of Olympus Corporation and CEO of Olympus Corporation of the Americas said, "Our investment in...
Source: MDDI - April 6, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Source Type: news
More Medical Device Businesses Impacted by COVID-19
The uncertainty surrounding COVID-19 is making it difficult for public companies to accurately forecast 2020 earnings. Irvine, CA-based Endologix recently joined a growing list of medical device companies that have withdrawn previously-reported financial guidance for the year.
The company makes endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once an AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture.
Endologix said AAA p...
Source: MDDI - April 6, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Battelle Earns FDA EUA for Decontaminating Respirator Masks
FDA has granted Emergency Use Authorization (EUA) to Battelle's CCDS Critical Care Decontamination System for processing up to 80,000 respirator masks per system each day.
CCDS employs concentrated, vapor-phase hydrogen peroxide (VPHP) for decontamination. The system has been validated to decontaminate masks of SARS-CoV-2, the company reported.
The masks are placed on shelves inside a container, and a portable, external VPHP system is hooked up to the outside of container. The system was first envisioned by Battelle as part of a study commissioned by FDA in 2015. That study involved determining the feasibility of N95 respi...
Source: MDDI - April 4, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Sterilization Source Type: news
