MedTech News
FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System
Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System.
Front Line Medical wins CE mark for COBRA-OS device
Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device.
FDA clears computer-assisted thrombectomy system from Penumbra
Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system.
Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for vessels of the peripheral arterial and venous systems
PLEASANTON, Calif., April 22, 2024 /PRNewswire/ — Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food and Drug Administration. This announcement introduces a new and exciting player in the peripheral thrombectomy market.
FDA clears new Zenition 30 mobile C-arm from Philips
Philips (NYSE: PHG)+
announced today that the FDA granted 510(k) clearance for its Zenition 30 mobile C-arm.
FDA approves Lumicell’s breast cancer imaging tool
Lumicell developed the technology to help physicians detect residual cancer in the breast cavity after surgery.
Cochlear receives FDA clearance to lower the age for the Osia System to 5-years-old
The Osia System, which launched commercially in 2020, is indicated for people with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD)
Scopio Labs wins de novo nod for bone marrow analysis software
Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.