FDA launches communications pilot to enhance medical device recall programme
The pilot by the FDA’s CDRH will improve communications about corrective actions being taken over certain medical device ...
medtechdive1d
FDA plan would alert public sooner on high-risk device recalls
The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of ...
STAT3d
New details on a risky medical device show need for more FDA transparency, researchers say
IVC filters, implants that prevent blood clots, aren't meant to be permanent — but doctors often forge to retrieve them.
JD Supra3d
Upcoming FDA Meeting Focuses on Generative AI in Medical Devices
The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its ...
Becker's Hospital Review1d
FDA looks to improve communication on high-risk medical device recalls
The FDA's Center for Devices and Radiological Health announced a pilot program designed to improve the timeliness of communications regarding high-risk medical device recalls.
Ars Technica3d
Horrifying medical device malfunction: Abdominal implant erupts from leg
After Brand filed her lawsuit in 2013, other patients filed lawsuits against the IVC filter maker, Cook Medical ... This requires device makers only to prove to the FDA that their device is ...
American College of Radiology2d
ACR Presents to FDA on Oversight Considerations for GenAI Medical Devices
The American College of Radiology® (ACR®) presented Nov. 20-21 at the U.S. Food and Drug Administration (FDA) Digital Health Advisory Committee (DHAC) meeting “Total Product Lifecycle Considerations ...
Becker's Hospital Review9d
FDA warns of arterial bypass device safety concerns: 5 things to know
Due to the recall and limited alternative device options, the FDA has added endoscopic vessel harvesting devices to the medical device shortage list. The FDA warning includes guidance and ...
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
News Medical24d
Medical Device Categories Explained
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock ...
Yahoo Finance23d
Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy ... new opportunities for our already FDA-approved Esteem® device. This week, we are celebrating ...