Lehigh Valley medical device maker settles lawsuit over faulty equipment for nearly $40 million

An Upper Saucon Township company that specializes in surgical equipment will pay $38.5 million to settle allegations under ...
MassDevice

B. Braun subsidiary Aesculap to pay $38.5M to resolve False Claims Act allegations

The U.S. DOJ announced that B. Braun subsidiary Aesculap agreed to pay $38.5 million to resolve allegations under the False ...
Becker's Spine Review

Medical device company to pay $38.5M to resolve false claims allegations

Aesculap Implant Systems, an orthopedic and spine device maker, agreed to pay $38.5 million in order to resolve False Claims Act allegations.  The agreement resolves allegations that between July 2010 ...
LVB

Aesculap settles federal investigations

Center Valley-based medical device company, Aesculap Implant Systems, LLC said it has resolved federal investigations into ...
Hosted on MSN

Device claims to protect athletes’ brains, but records reveal doubts at FDA

One day this summer, Pat McAfee, the former NFL punter turned ESPN personality, interviewed New York Jets cornerback Sauce Gardner about his partnership with Q-Collar, the only medical device cleared ...
JD Supra

Marketing Medical Devices: Navigating Increased FDA Scrutiny

With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...

Withings has received FDA clearance for medical 'multiscope' BeamO

Withings announced that its multi-function medical device BeamO has received clearance from the FDA. BeamO contains sensors to perform an electrocardiogram, a stethoscope and a thermometer. The ...