Devices
A 1/29-2/15 FDA inspection at InfuTronix, Natick, MA, found Quality System Regulation and Medical Device Reporting violations in the firm’s production of infusion pumps and associated administration sets. A just-released 6/16 Warning Letter says specific violations were: * failing to analyze processes, work operations, concessions,
Devices
A federal appeals court has overturned a district court decision to dismiss, due to federal preemption, product liability claims under the Connecticut Product Liability Act (CPLA) involving Bausch & Lomb’s Trulign Toric intraocular lenses. The federal appeals court ruling will now allow the product liability case to proceed. In
Devices
CDRH is soliciting proposals for medical device site visits that can be accommodated in person or virtually as part of its Experiential Learning Program. In addition, the Center encourages proposals addressing patient engagement as a supplemental topic to the current observance of operations in the areas of research, device development,
Drugs
Some 99 organizations that represent patients with rare diseases and other acute or chronic health conditions are urging congressional leadership to “resume negotiations to develop a comprehensive FDA user fee package.” In an 8/1 letter, the organizations say they are “deeply concerned about the impact that a delay in
Devices
Charles River Laboratories is petitioning FDA to change its regulation of endotoxic contamination assays, including licensure of all such assays, to include those that are currently unlicensed. The Charles River 8/1 petition says that for the past 50 years, the leading assays used to detect possible endotoxic contamination in
Devices
Attorney and data scientist Bradley Thompson (Epstein Becker Green) says his review of data on breakthrough device designation for 510(k)s indicates the process is not likely to be helpful for those devices. Writing in his firm’s Health Law Advisor, Thompson says that when he works with medical
Devices
CDRH director Jeffrey Shuren says that with the Environmental Protection Agency poised to propose an air pollution rule later this year to address emissions of ethylene oxide (EtO) at commercial sterilizers, FDA is working with the industry on steps to reduce emissions and also to maintain sufficient sterilizing capacity. In
Devices
FDA has approved Allergan Aesthetics’ Juvéderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. The approval was based on data from the company’s pivotal clinical study that showed Juvéderm effective at improving jawline definition (69.9%
Devices
FDA has cleared a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy. The device comprises three heparin-coated titanium stents
Devices
Attorney Keeley McCarty (Sheppard Mullin) says Department of Justice (DoJ) prosecution of Prometheus Group is a reminder that the government will use the False Claims Act (FCA) to target medical device manufacturers for off-label use of medical devices, even when healthcare providers have decided the devices are safe and
Devices
Jones Day attorneys say CDRH is considering a total product lifecycle-based framework for the oversight of artificial intelligence/machine learning (AI/ML)-enabled medical devices that would “allow for modifications to be made from real-world learning and adaptation while ensuring that the safety and effectiveness” of these devices
Devices
FDA has cleared a bioMérieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury (AKI). The device is intended to be used in conjunction with clinical evaluation as an aid to support the risk assessment of moderate or severe AKI
Devices
North American Diagnostics has recalled (Class 1) its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without FDA authorization, clearance, or approval. “North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate,” a
Devices
Law firm Sidley has drawn attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to “embrace the arguments asserted in a Statement of Interest filed by Department of Justice (DoJ).” In a post on Sidley’s False Claims Act (FCA) blog, the law firm
Devices
FDA has cleared a Siemens Healthineers 510(k) for the ARTIS icono ceiling, a ceiling-mounted angiography system designed for routine and advanced procedures in interventional radiology and cardiology. The device’s new rotational capabilities and simplified cabling of its C-arm permit cone beam CT data acquisitions in 2.
Devices
An FDA safety communication warns consumers about the potential risk of injury associated with using certain brands of ultraviolet (UV) wands. “Do not use these UV wands for disinfection because they may expose the user or any nearby person to unsafe levels of ultraviolet-C radiation and may cause injury
Devices
Medtronic’s Covidien unit has recalled (Class 1) its Palindrome and Mahurkar catheters due to a defect in the hub that connects both extension catheters. “There is a potential leaking condition within the hub of specific chronic dialysis catheters,” a recall notice says. “This may be noticed when flushing one
Devices
FDA has approved a Lenstec PMA for its SBL-3 IOL (Segmented Bifocal Lens), described as a next-generation asymmetric multifocal refractive intraocular lens (IOL) that provides patients with near, intermediate and distance vision. The lens is designed to improve patient contrast sensitivity and minimize halo and glare (dysphotopsias) commonly
Devices
FDA has issued a draft guidance to help ensure that information is available to patients and health care professionals about the benefits and risks of LASIK devices, which are used in vision correction (e.g., nearsightedness, farsightedness, and astigmatism) surgeries. Interested parties can comment on the guidance until 10/26.
Devices
FDA has cleared a Viz.ai 510(k) for its Viz Subdural (SDH), an algorithm that uses artificial intelligence (AI) to automatically detect subdural hemorrhages. “Viz SDH is the only SDH-specific AI-powered detection and care coordination platform with the ability to identify acute and chronic subdural bleeds, then
Devices
FDA has cleared an iRhythm Technologies 510(k) for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. The artificial intelligence algorithm allows the sensor-based watch to provide long-term continuous monitoring for atrial fibrillation (AFib). ZEUS is being produced in partnership with Verily, an Alphabet precision
Devices
FDA has cleared a Northeast Scientific 510(k) for reprocessing Philips’ Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, which is used to treat peripheral arterial disease. The company says it is the first FDA clearance for reprocessing this type of atherectomy catheter. The device uses high-energy ultraviolet