Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into the TAP program.

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...

SeaStar Medical (ICU) announced that the U.S. FDA has approved an investigational device exemption application to evaluate the safety and ...

With $10 million in new funding, Teal Health co-founder Kara Egan shares how her health care startup intends to reach its first patients.

Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...

The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...