FDA clears Cepheid’s multiplex respiratory panel test
September 30, 2026
The panel is designed to identify 13 common bacterial and viral respiratory pathogens from one nasopharyngeal swab.
The panel is designed to identify 13 common bacterial and viral respiratory pathogens from one nasopharyngeal swab.
Intuitive (NASDAQ: ISRG) continues to get back to its roots, claiming a European approval for its da Vinci 5 system in minimally invasive cardiac procedures.
Mobile platform combines smartphone technology, a proprietary light-occluding headset, and AI-assisted software to capture and analyze nystagmus without complex equipment.
DALLAS, Sept. 28, 2026 /PRNewswire/ — Insera Therapeutics, Inc., a medical device company focused on advancing cyclical aspiration for mechanical thrombectomy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CLEAR™ Aspiration System.
After de-emphasizing heart surgery for decades due to limits with its earlier platforms, the surgical robot maker is eyeing the large market in cardiovascular disease treatment.
The proposed prescription-only product would be separate from Glytec’s existing Glucommander technology.
Marani’s M•wrap for foetal and and maternal heart signal monitoring is intended to give patients an at-home monitoring option versus travelling to a clinic.
The panel voted 7-2 vote in favour of GRAIL’S Galleri multi-cancer early detection (MCED) test’s benefits outweighing its risks.
FDA Clearance and CE Mark Complete Aptiva’s Antiphospholipid Syndrome Portfolio, Expanding Global Access to Comprehensive APS Testing
Xenix Medical has announced FDA 510(k) clearance for its Riva Anchor Spinopelvic Fixation System, designed to facilitate fusion of the sacroiliac joint at the base of a posterior lumbar or thoracolumbar fusion construct.