We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Monitoring both brain and somatic tissue oxygenation simultaneously may further improve clinicians’ ability to provide rapid and accurate care, the company said. Read More
One complaint related to a guidewire that stuck to a stent during a cystoscopy procedure, and another involved the failure of a grip that required replacement of the device during surgery. Read More
Australia’s Therapeutic Goods Administration move to exempt from regulation certain classes of software-based medical devices that present a lower risk to safety drew broad support in written comments to the agency. Read More
Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More
Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, California facility. Read More
The FDA has revoked the emergency use authorization (EUA) for protective barrier enclosures used by healthcare providers when caring for patients thought to be infected with COVID-19 to prevent exposure by providing an extra layer of protection in addition to personal protective equipment. Read More
The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Read More