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In this edition of Quick Notes, the FDA clears an endoscopic camera capsule for home use, some of GE Healthcare’s ultrasound imaging software shows cyberattack vulnerability, and the FDA clears self-collection of vaginal swabs for HPV testing, and OKs a new cardiac cath guidewire. Read More
A recall of more than 1 million Boston Scientific angiographic catheters from certain batches has been considered Class I by the FDA due to an increase in complaints about an inability to advance the guidewire through the lumen of the device for certain batches. Read More
A patient-reported outcome instrument that assesses vision symptoms before and after intraocular lens implant surgery is now a part of the Medical Device Development Tools (MDDT) program.
For the third time this year, the FDA has deemed an Abbott recall of its HeartMate 3 Left Ventricular Assist System (LVAS) as Class I, the most serious type of recall, following 81 reported incidents, 70 injuries and two deaths related to the issue. Read More
If CDRH doesn't get $11.5 million from Congress this year to keep up its program to prevent medical device supply chain disruptions, the program will go dark next year, said center director Jeff Shuren on Tuesday during an Alliance for a Stronger FDA webinar focused on the budget. Read More
The 2023 annual survey of members of Team NB, The European Association Medical Devices — Notified Bodies, shows a steady increase in both applications and certificates issued by association members, as well as an increase in number of notified bodies. Read More
Adding a chapter to the prolonged, back-and-forth legal battle involving recalled continuous positive air pressure (CPAP) machines, Philips Respironics filed a complaint in a Pennsylvania federal court Friday insisting SoClean — manufacturer of ozone-based cleaning systems for breathing devices — pay part of a $1.1 billion settlement Philips reached last month with consumers who claimed they were injured by the devices. Read More
Cue Health must immediately stop sale and distribution of its COVID-19 tests and consumers should throw away any of the tests they may still have, the FDA says, following an inspection of the company’s San Diego facility last fall. Read More