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 ...

Upcoming events in the coming weeks and months include two FDA advisory committee meetings, MAGI 2024: The Clinical Research Conference as well as webinars on choosing the right IRB review partner, ...

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 ...

The Securities and Exchange Commission (SEC) announced Monday that Quanta and two of its top executives have agreed to settle fraud charges brought against the company, stemming from statements the ...

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.

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 ...

The Chiesi Group has received FDA approval for Lamzede (velmanase alfa-tycv) for treatment of adult and pediatric patients with non-central nervous system manifestations of alpha-mannosidosis, a rare ...

The FDA has issued Soligenix a Refusal to File letter for its HyBryte (synthetic hypericin) new drug application (NDA), deeming it not sufficiently complete for a substantive review. Soligenix said it ...

A Florida district judge said Tuesday that the nearly 50,000 complaints filed against multiple drugmakers alleging Zantac (ranitidine) causes cancer cannot form larger multi-plaintiff injury cases and ...

Florida-based medical device specification developer KL Distributing was handed a Form 483 for inadequate purchasing controls, training, medical device reporting (MDR) and other lapses.