Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.

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.

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. 

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. 

The US agency announced this week that it’s reviewing multiple reports of a form of carcinoma that arises in the scar tissue around a breast implant.

Device developers who want to ensure the best possible reimbursement for their products should be thoughtful in how they approach the US Centers for Medicare and Medicaid Services, agency officials said during a recent meeting.