[…]
Quick Hits
Whistleblower lawsuit — Medical device giant Medtronic is facing allegations that it promoted a device for uses not approved by FDA, leading to patient injuries and false claims submitted to government payers, STAT reports. The whistleblower suit alleges the company sought approval for the device under false pretenses. Patient advocates say the case exposes the shortfalls of medical device regulations. If the device had been tested in a clinical trial it would have been clear that it was designed to fit a part of the spine the company wasn’t seeking approval for, Diana Zuckerman of the National Center for Health Research explained to STAT. Medtronic has not yet responded to the suit. […]
To see the original article, click here