MedTech News
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.
FDA approves Lumicell’s breast cancer visualization system
Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal.
Scopio Labs Receives Groundbreaking FDA Clearance for First-Ever Digital Bone Marrow Aspirate Application
The company’s 3rd FDA clearance accelerates the shift to AI-powered digital hematopathology, enhancing diagnostic speed and patient care
Xstim, Inc. Receives FDA Approval for Xstim™ Spine Fusion Stimulator.
IRVING, Texas, April 16, 2024 /PRNewswire/ — Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstim™ Spine Fusion Stimulator