SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux saw a ...

This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for ...

Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common ...

Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing ...

A federal appeals court has taken action to allow the abortion medication Mifeprex and its mifepristone generic forms to stay on the market, with the same restrictions that existed before FDA loosened ...

The U.S. Supreme Court (SCOTUS) on Thursday struck down Amgen’s attempt to revive patents on its cholesterol medicine Repatha (evolocumab), effectively preventing the company from monopolizing an ...

Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple types of cancer.

Sens. Raphael Warnock (D-Ga.) and John Kennedy (R-La.) have introduced the Affordable Insulin Now Act of 2023, which would cap out-of-pocket insulin costs at $35 a month for both insured and uninsured ...

The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.

Abbott’s MitraClip cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary mitral valve regurgitation (MR) in a five-year study at multiple U.S.

Now you can have the same investigation manual for 2019 that the FDA investigators use. Know what the investigators look for — before they even get there. Know the investigators’ expectations and ...

Texas-based Dalton Medical, a manufacturer of powered wheelchairs, adjustable hospital beds and other durable medical equipment, received a Form 483 for failure to establish design control and ...