A bill aimed at preventing laboratory reimbursement cuts has been reintroduced in the US Congress. Additionally, an Abbott valve landed FDA approval, On Target Labs reported trial results, and the FDA warned that dental palate expanders may pose health risks to adults.

A proposal that would give some patients gift cards in exchange for returning a screening test sample would not violate anti-kickback law because it doesn’t encourage medically unnecessary services, HHS-OIG says.

The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.

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.