Devices
FDA has issued a warning about the potential risk of injury associated with the use of Max-Lux Corp.’s Safe-T-Lite UV Wand because users and those nearby may be exposed to unsafe levels of ultraviolet-C radiation that may cause injury to the skin, eyes, or both
Devices
Magellan Diagnostics has recalled its LeadCare II, LeadCare Plus, and LeadCare Ultra blood lead tests due to concerns about false low results. The agency says a false low result may lead to health risks in special populations such as young children and pregnant individuals. “A pregnant or lactating individual'
Devices
Affordable Healthcare Solutions pleaded guilty in a Florida federal court to receiving adulterated medical devices in interstate commerce and delivery for pay with intent to defraud or mislead. The court fined the company and ordered it to forfeit $837,000 worth of medical devices seized during a search warrant executed
Devices
FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. The requirement is articulated in a 2006 guidance document, but FDA now believes it is “possible in certain circumstances for IVD
Devices
FDA is alerting health care providers on recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. “The FDA is evaluating a study published in the Journal of the American Medical Association (JAMA) Cardiology,” an agency
Devices
Armstrong Medical has recalled its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow that may cause a reduced flow of air to the patient. A recall notice says the difficulties in flow may cause a failure in the pre-use
Devices
FDA says it has revised the authorizations of certain molecular, antigen, and serological tests for Covid-19 to help ensure that the tests’ performance is not affected by emerging SARS-CoV-2 viral mutations. An agency announcement says the revisions require additional conditions of authorization concerning viral mutations. FDA says
Devices
Cordis has recalled its Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the bands to move or dislodge during procedures. The movement can happen where the catheter is trapped between another device and the vessel wall, according to a recall notice. Such movement
Devices
Washington Legal Foundation (WLF) says the California Court of Appeals should reverse a trial court decision that imposed $344 million in civil penalties on Ethicon for disseminating what WLF says is fully protected scientific speech. A WLF statement says the trial court found that every communication the defendants made about
Devices
AdvaMed says it supports FDA efforts to clarify which activities performed on medical devices are remanufacturing or servicing. In a 9/22 comment on an agency draft guidance, the association says that much device servicing performed by third-party servicing entities is actually remanufacturing and subject to FDA remanufacturing requirements.
Devices
FDA has announced a 12/3 virtual public workshop entitled “Orthopedic Device-Related Infections II Workshop.” This will be the second workshop sponsored by the agency to provide information about infections related to orthopedic devices and to seek feedback on current and potential future strategies for protecting and promoting public
Devices
FDA, which partnered with ECRI, an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation, has published the first four safety summaries. The documents cover magnesium, polypropylene, polyurethane, and siloxanes. The review for
Devices
The Medical Imaging & Technology Alliance (MITA) says it is concerned that an FDA draft guidance on remanufacturing of medical devices will not achieve its intended outcome given that the agency is relying on third-party servicers and independent service organizations (ISOs) to comply with the guidance. A MITA 9/
Devices
FDA has authorized the de novo marketing of Paige AI’s Paige Prostate software that is intended to assist pathologists in detecting areas that are suspicious for cancer as an adjunct to reviewing digitally-scanned slide images from prostate biopsies. The artificial intelligence (AI)-based software is designed to identify
Devices
FDA has issued an alert about the potential for false positive results with Abbott Molecular’s Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. False positive results may be related to current mixing parameters of the polymerase chain reaction mixture that may result
Devices
FDA has approved a Neovasc IDE for the company to begin the COSIRA-II IDE clinical trial later this year for its Reducer device and its use in treating certain patients with refractory angina pectoris. The company says the trial is designed to address issues raised during a 10/2020
Devices
FDA has cleared a Gynesonics 510(k) for the Sonata System 2.2 for treating fibroids. The company says the new device features a 20% reduction in the smallest ablation size setting, which increases the ability to treat fibroids in tighter anatomical locations. The device also has new software that
Devices
Massachusetts General Hospital researchers say deviations in FDA policy during the Covid-19 pandemic may offer a blueprint for regulatory oversight of laboratory-developed tests (LDTs). The study was published in the Journal of Molecular Diagnostics. A hospital news release says that during the pandemic, FDA (1) required makers of
Devices
FDA is reminding healthcare providers about the potential for aluminum leaching and exposing patients to high levels of aluminum as a result of using certain fluid warmers. An agency statement says information reviewed by FDA indicates that aluminum leaching may occur when the fluid warmer is designed with an aluminum
Devices
FDA has released a revised guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease Public Health Emergency. The revised document addresses barrier face coverings intended for medical purposes but not intended to provide liquid barrier protection. It includes recommendations
Devices
FDA has cleared an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular catheters. The device is designed to provide imaging and guidance to improve the placement of external ventricular drains, according to the company. inTravent says the device allows health
Devices
FDA has granted Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in treating patients with moderate to severe obstructive sleep apnea and complete concentric collapse of the soft palate. The designation is based on data from the company’s BETTER SLEEP trial.