Devices
FDA is updating a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with an abdominal aortic aneurysm (AAA) based on new labeling approved for the currently available product, the AFX2 Endovascular AAA System (AFX2), that includes information to better describe the risk of Type
Devices
FDA says final results from a required post-approval study (PAS) on Abiomed’s Impella RP System confirmed the survival rate seen in premarket data, adding that the device is safe and effective when used for the currently approved indication. The device was approved in 2017, and in 2019 FDA
Devices
FDA has added Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices to its device shortage list. A letter from the manufacturer blames “ongoing supply chain issues” and raw material shortages that have affected its ability to build IABPs, intra-aortic balloon catheters and spare parts. It includes guidance for
Devices
FDA has issued Cutera a Warning Letter related to marketing material that appeared on a company owned Web site about gynecological indications, including vaginal rejuvenation, for a device designed and manufactured by a third party. The letter, which has yet to be publicly released, stems from a 2019 commitment the
Devices
Medtronic sent an 11/29 “Dear Doctor” letter with important safety information related to the potential hardening of the controller driveline cover of its HeartWare Ventricular Assist system. “Over time,” the letter says, “the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to
Devices
The Sedgwick Recall Index for the second quarter of 2022 says that medical device recalls hit a two-year high with 268 events, up 34% from the 200 recalls in the first quarter. However, the report says, the number of affected units dropped by 96.8% to 10.1 million
Devices
FDA has approved an Enovis PMA for the STAR Patient Specific Instrumentation (STAR PSI System) and its use with the company’s STAR total ankle replacement system. The new device provides a personalized pre-operative plan for each patient, Enovis says, including a 3D visualization of the patient’s ankle
Devices
Ombu Enterprises is petitioning FDA to take administrative action to make unique device identifier (UDI) information publicly available in the MAUDE (Manufacturer and User Facility Device Experience) database and the Recall database. The petition says one significant role of publicly available elements in the databases is to provide specific information
Devices
Friends of Cancer Research CEO Jeff Allen and American Cancer Society Action Network president Lisa Lacasse say Congress should pass the VALID (Verifying Accurate Leading-edge IVCT Development) Act to “set a clear, modernized regulatory framework to ensure that any test, no matter where it is developed, meets the same
Devices
A former Becton Dickinson (BD) medical director and safety monitor has petitioned FDA to refer the company to the U.S. Justice Department for allegedly violating the False Claims Act related to a safety defect with the company’s 510(k)-cleared Genesis Sterilization Containers. The devices are intended to
Devices
FDA has cleared a NeuroLogica 510(k) for its head-to-toe trauma imaging, the BodyTom 64 Point-of-Care Mobile Computed Tomography (CT) Scanner. The full-body 64-slice device is an upgraded version of the company’s 32-slice BodyTom Elite CT scanner, the company says. “Based on
Devices
CDRH has qualified the “CHemical RISk calculator (CHRIS) — Color Additives” under its Medical Device Development Tools program. The CHRIS tool is described as a non-clinical assessment model that can be used by device firms to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical
Devices
FDA is alerting healthcare professionals that certain Luer-activated valve (LAV) connectors (sometimes referred to as needleless Luer access devices or needleless connectors) with internal pin designs may not be compatible with prefilled glass syringes. An agency notice says the internal pin of the LAV connector may break when attached
Devices
FDA has cleared a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage triage and notification device with what the company says is a sensitivity of 97% and specificity of 100%. “While Rapid ICH uses artificial intelligence to quickly analyze non-contrast CT scans and notify
Devices
FDA issued 11/22 an emergency use authorization for the Lucira Covid-19 and Flu Test for use in a point-of-care setting. An agency notice says the Lucira product is a single-use molecular test intended for the detection of both the SARS-CoV-2 virus and influenza
Devices
FDA says the Baxter Hillrom 9/30 recall of 8,550 WatchCare Incontinence Management Systems due to a risk of RF interference with nearby medical equipment is Class 1. An agency notice says the recalled units were distributed between 8/1/2018 and 9/1/2022. Baxter Hillrom recalled the
Devices
Three Ropes & Gray attorneys say it is likely that some aspects of the FDA final guidance on clinical decision support (CDS) software released in September will be controversial. Speaking on their firm’s Non-binding Guidance podcast, the attorneys note that the final guidance “represents a substantial change in
Devices
FDA says it received more than 21,000 medical device reports (MDRs) from 8/1 to 10/31 associated with PE-PUR foam breakdown in Philips Respironic ventilators, BiPAP machines, and CPAP machines. There were 91 reports of deaths in the latest reports, the agency says. The FDA notice says
Devices
FDA has updated a Web page it maintains on Medtronic recalls involving its HeartWare Ventricular Assist Device system that is intended to enhance user access to information about safety issues with the device. For example, the latest notice includes a recent letter from Medtronic that says two groups of the
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Persona OsseoTi Keel Tibia for cementless knee replacement. The device features a new porous version of the Persona anatomic tibia with Zimmer Biomet’s OsseoTi Porous Metal Technology, which uses anatomical data in combination with 3D printing technology to build
Devices
FDA says it has asked for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of its Trilogy ventilators that have been “reworked” as a part of a 6/2021 recall. The information request is intended to help FDA better understand the cause
Devices
FDA has classified as Class 1 an Insulet recall of its Omnipod DASH Insulin Management System due to battery issues. The device is used to deliver insulin at set and variable rates to manage diabetes in people who need insulin. According to an agency notice, the recall was initiated after