SeaStar Medical Holding Corporation has announced the shipment of its QUELIMMUNE™ device to a leading academic medical center, marking its fourth commercial customer. QUELIMMUNE is designed to treat ...

The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, ...

MURRAY, Utah (ABC4 Utah) – Intermountain Medical Center in Murray has made medical history as the first hospital in the United States to perform a new procedure using a groundbreaking device for ...

SARASOTA, Fla.--(BUSINESS WIRE)--Center For Sight, A US Eye Company, one of the nation’s leading ophthalmology practices, has performed the first iDoseTR implant surgery in the state of Florida since ...

RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies, today announced continued commercial momentum with a growing ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...

The rapid progress of Generative Artificial Intelligence (GenAI) has raised concerns about the sustainable economics of emerging GenAI services. Can Microsoft, Google, and Baidu offer chat responses ...

An unproven and unregulated dental device at the center of patient lawsuits has not been evaluated by the FDA, according to a months-long joint investigation by KHN and CBS News. More than 10,000 ...