The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...

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

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

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's randomised trial involving its fast-resorbable embolic microsphere, Nexsphere ...

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

Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...

Dr Tsun Sean Law details the ARISE trials and outlines other orthobiologic treatments currently available — but not yet ...

Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational ...

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

First FDA-Cleared Antibiotic-Eluting BioEnvelope Now Available ... Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients ...

FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.