Joey Jermaine Francois, 45, of Morgan City, is charged with manufacture and possession of a bomb, as well as several drug offenses.

Nelson Labs' Thor Rollins becomes a convener of ISO 10993-1, driving advancements in biocompatibility standards.

HeartBeam (NASDAQ: BEAT) was among the medical device companies highlighted in a Jan. 8 report by Modern Healthcare by ...

The FDA today issued a warning related to certain heart pump technologies made by Johnson & Johnson MedTech's Abiomed unit.

Doctors say that identifying the right patients will be critical to the future of the field. Only time will tell, according to trialists.

Allurion saw its shares jump roughly 60% on Monday, Feb. 23, as the FDA signed off on the medtech’s premarket approval ...

Where FDA breakthrough devices stand through 2025: growth, authorizations, leading specialties, AI trends, and qualification pathways explained.

Creating a drug that might help treat or cure a health condition in humans is a long, complex process. After developing a ...

The FDA is flagging a high-risk issue with blood glucose monitors manufactured by Trividia Health that the company says is tied to 114 serious injuries and one death since the devices’ launch 12 years ...

A provocative new proposal has offered the FDA a way to let a broad swath of potentially risky AI devices flood the market.

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

The FDA clearance of GE HealthCare’s next-generation Signa products aligns with the company’s multi-year strategy to differentiate its MRI portfolio.