Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk ...

Mursla Bio, a Cambridge UK and Boston US leader in Extracellular Vesicle (EV) science, has received FDA approval for its lead ...

The bone graft incorporating rhBMP-2 has received FDA IDE approval for a pivotal clinical trial in spinal fusion ...

Orchestra BioMed Holdings shares rallied premarket after the maker of medical devices said a blood-pressure mechanism received breakthrough status from the U.S. Food and Drug Administration, allowing ...

Indianapolis-based software company Greenlight Guru, which helps medical-device makers more easily navigate the FDA approval process, said it has heard from numerous concerned customers.

The US FDA is coping with a series of Trump-imposed job cuts. These are starting to hamper food safety and pharmaceutical ...

FDA has also been proactive in approving AI-driven medical devices, with more than 1,000 AI containing products authorized through established premarket pathways. These approvals reflect the ...

Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary ...

Tim Boreham sharpens his knifes to look under the hood at cardiac pacing device innovator EBR Systems after its US FDA ...

The US FDA has approved EBR System's leadless pacemaker WISE, the only heart device able to deliver left-ventricle ...

Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's application to initiate an Early Access Program for its investigational inhaled sed ...

The results of the study will be used to apply for FDA premarket approval (PMA ... Adagio is a medical device company focused on developing and commercializing products for the treatment of ...