The Chicago-based medical technology company said the MRI device, called Signa Magnus, had received 510(k) clearance by the U.S. Food and Drug Administration. That approval pathway is for devices that ...

DENVER, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device ... FDA deadline to begin patient ...

Number three, gaining FDA approval for the Allurion Balloon and preparing for ... Our new strategy is inspired by the successful approaches taken by other cash pay medical devices, especially ...

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable ...

Lucid Diagnostics Inc.  ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: ...

The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...

Nov 13 (Reuters) - The U.S. Food and Drug Administration approved PTC Therapeutics' (PTCT.O), opens new ... PTC Therapeutics ...

SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...

GE HealthCare says the head-only design allows the system to deliver a gradient amplitude and slew rate far surpassing those ...

The IDE will allow the medtech giant to conduct clinical trials at US sites with the robotic surgical system called Ottava.

Abbott's Freestyle Libre 2 and 3 are the first CGMs to receive FDA clearance for use during imaging tests like X-rays, CT scans, and MRIs.