Warning Letters And Close-Outs – February 2023
The US FDA released three device-related closeout letters in February, resolving past citations against BioModeling Solutions, Sooil Development Co., and USA Medical LLC. No new warning letters were issued.
You may also be interested in...
News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More
News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.
Pain Device Firm’s Undoing Over $16K ‘Piece of Plastic’
Neuromodulation company Stimwave has agreed to pay $10M in fines and the ex-CEO is facing health care fraud charges after a whistleblower revealed the company was selling a fraudulent “receiver” component.
News We’re Watching – FDA Nixes Neuralink Trials, Layoffs at J&J, Novel Knee Implants
This week, we learned that the US FDA thinks Elon Musk’s Neuralink brain interface device isn’t ready for human trials. Additionally, J&J cut about 300 medtech jobs, Stryker launched a knee implant, and Active Implants’ meniscus replacement device made it to the FDA’s advisory panel calendar.