On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® ...

CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough ...

CFO Raffi Asadorian reported that Talphera reduced Q4 2024 operating expenses to $3 million from $4.6 million in Q4 2023, with further cash operating expenses for 2025 projected at $18-$19 million.

Supira Medical has completed a $120m Series E funding round, with plans to use the capital to advance its position in the ...

EQS-News: Nyxoah SA. / Key word (s): Miscellaneous FDA Issues Nyxoah an Approvable Letter for its Genio® System 26.03.2025 / 09:45 CET/CEST The issuer is solely responsible for the content of this ...

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...

The drug, tested on mice, restored these gamma oscillations, and in turn reconnected neurons to essentially heal the brain damage without arduous physical rehabilitation.

A new study has discovered what researchers say is the first drug to fully reproduce the effects of physical stroke rehabilitation in model mice, following from human studies. A new study by UCLA ...

The FDA PMA submission represents a major milestone for Perimeter, marking their first regulatory approval application for AI-enabled wide-field OCT technology. Perimeter Medical Imaging AI has ...