CAMBRIDGE, Mass.-- (BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma ...

ATLANTA, Dec. 9, 2024 /PRNewswire/ --Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug ...

DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation ...

DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of ...

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its ...

Pending U.S. Food and Drug Administration ("FDA") Humanitarian Use Device ("HUD") Classification and Approval as a HUD, Company Expects to Begin Commercializing Reducer in U.S. by Early 2020 ...

The FDA released a draft guidance on the submission process for humanitarian use device designation for devices that diagnose or treat diseases and conditions effecting fewer than 4,000 Americans per ...

DENVER, Oct. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences ...

Nativis, a clinical-stage therapeutic device company developing non-sterile, non-invasive, non-thermal treatments for cancers and other serious diseases, announced it has received notice from the Food ...

Micropacemaker to treat foetus with heart block Reported in the journal Heart Rhythm, the micropacemaker has been designated a Humanitarian Use Device by the US Food & Drug Administration (FDA).

“We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added.