Devices
Philips Respironics has recalled (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power malfunction. The product correction recall notifies customers to update the devices to the latest software version (1.05.06.00) to prevent “Battery Depleted” or “Loss of Power”
Devices
FDA has issued a warning for healthcare providers and consumers not to use Cue Health’s Covid-19 tests in either home or patient care settings due to increased risk of false results. Users are recommended to consider retesting using a different Covid-19 test if a negative result was
Devices
Megadyne is recalling and removing from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient burn injuries in procedures where they were used. “A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential
Devices
Route 92 Medical is recalling (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instances of distal tip separation at the proximal marker band. The catheters that separated were made by an outside contract manufacturer, a recall notice says. “Additional investigations determined that
Devices
Vyaire Medical has recalled (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the company’s Vyntus CPX cardiopulmonary exercise test device. The Twin Tube line is connected to the adapter for the digital volume transducer that provides an exact determination
Devices
DuVal & Associates has submitted an amicus brief to the Supreme Court urging it to hear the appeal of two former Acclarent executives from a 1st Circuit Court of Appeals decision upholding their conviction on misdemeanor charges of distributing misbranded and adulterated medical devices. The appellate judges upheld the convictions
Devices
FDA has published a final guidance, Remanufacturing of Medical Devices, to clarify for the medical device industry the definition of “remanufacturing” for reusable medical devices needing maintenance or repair. The document says there has been a lack of clarity about the distinction between “servicing” and “remanufacturing” of a device. “Most
Devices
FDA is alerting healthcare providers and facilities about its ongoing safety and quality concerns with some Getinge/Maquet cardiovascular medical devices. The affected devices are the Getinge/Maquet/Datascope hybrid and rescue intra-aortic balloon pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets. A 5/8
Biologics
As directed by a presidential Executive Order, FDA, EPA and the Department of Agriculture have developed a joint regulatory plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. An FDA statement (includes a link to the plan) says the plan “incorporates processes and timelines
Devices
An 11/6-11/11/2023 FDA inspection at China’s Bioptimal International manufacturing facility in Singapore identified Unapproved Device, Quality System Regulation, and Medical Device Reporting violations in the firm’s manufacturing of the Thermodilution Catheter and Pulmonary Artery Monitoring Catheter. A just-released 4/3 Warning Letter says
Devices
Federal Register notice: FDA is announcing that the CDRH Office of Product Evaluation and Quality has modified its organizational structure. The new structure was approved by the HHS 12/21/2023 and it became effective 1/22. To view the notice, click here.
Devices
Six Hogan Lovells attorneys say litigation challenging the FDA final rule asserting the agency’s authority to regulate laboratory-developed tests remains likely, based on longstanding industry claims that the rulemaking exceeds FDA’s authority. Writing in a comprehensive analysis of the final rule that will become effective 7/5,
Devices
FDA has approved a Geneoscopy PMA for its colorectal cancer stool-based screening test ColoSense, indicated for adults aged 45 years and older who are at typical average risk for developing colorectal cancer (CRC). Designated as a breakthrough device earlier by FDA, the company says )the test is the “first
Devices
FDA has cleared a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System. ZygoFix’s device “harnesses the spine’s innate bone structure to securely lock its connecting joints,” the company says. “Unlike traditional methods, the company's innovative implant adapts to the joint's anatomy during
Devices
FDA has cleared a Phonak 510(k) for a self-replacement option for its Phonak Lyric hearing aid. The self-replacement is a hearing professional-guided option for patients who choose to replace their Lyric hearing aids every other time on their own. The company says the self-replacement option
Devices
Senior medical device regulation expert Lisa Baumhardt (Hyman, Phelps & McNamara) says aspects of a recent FDA draft guidance on Requests for Feedback and Meetings for Medical Device Submission: The Q-Submission Program “could have a negative impact on future pre-submissions.” Writing in her firm’s FDA Law Blog,
Devices
Abbott’s Thoratec unit has recalled (Class 1) its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak. A recall notice says there is risk of a “leak path at the seal interface between the left ventricle assist system inflow cannula and the
Devices
CDRH has qualified the Apple Watch’s Atrial Fibrillation (AFib) History Feature as a medical device development tool (MDDT) for use as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation
Drugs
Doctors for America (DFA) says FDA should finalize its draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for regulated products with strong recommendations for industry compliance and providing ongoing support and resources to facilitate the adoption of inclusive practices in clinical research.
Devices
A 5/8-5/11/2023 FDA inspection at the P.T. Sankei Medical Industries manufacturing facility in Banten, Indonesia, found Quality System and Medical Device Reporting violations in its manufacturing of adulterated and misbranded medical devices. A just-released 9/19/2023 Warning Letter says the company manufactures a
Devices
FDA has cleared a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac (SI) joint fusion construct to be used with the Liberty-SI lateral transfixing system. The device is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative
Drugs
AdvaMed says FDA should update its draft guidance on key information and facilitating understanding in informed consent “to be clear about what levels of reimbursement, compensation, and recruitment incentives are problematic for medical device studies.” The association’s comment letter also suggests that HHS modernize its human subject protection guidance,