MedTech News
ZEISS MEL 90 excimer laser receives U.S. FDA approval; completes Corneal Refractive Workflow
DUBLIN, Calif. and JENA, Germany, Jan. 13, 2025 /PRNewswire/ — ZEISS Medical Technology announced today that the MEL® 90 received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism (a condition where both hyperopic and myopic correction is required).
Spear Bio Secures FDA Breakthrough Device Designation for its Novel pTau 217 Blood Test, Advancing Scalable Solutions for Early Alzheimer’s Disease Diagnosis
WOBURN, Mass., Jan. 13, 2025 /PRNewswire/ — Spear Bio Inc., a biotechnology company pioneering next-generation ultra-sensitive immunoassays, today announced that its pTau 217 blood test has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognizes the test’s potential to address a critical unmet need for the millions of Americans living with Alzheimer’s disease and not yet diagnosed.
Medtronic wins CE mark for adaptive deep brain stim tech for Parkinson’s
Medtronic (NYSE: MDT)+
announced today that it received CE mark approval for its BrainSense adaptive deep brian stimulation (aDBS).
Scientists engineer nanostructured surfaces hostile to bacteria but friendly to cells
Researchers from Tokyo Metropolitan University have created nanostructured alumina surfaces which are strongly antibacterial but can be used to culture cells.
FDA clears CapsoVision capsule endoscopy tech for pediatric patients
CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above.
Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Johnson & Johnson MedTech (NYSE: JNJ)+
announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter to treat AFib
Roche’s momentum in digital pathology continues with FDA clearance on its high-volume slide scanner
TUCSON, Ariz., Jan. 9, 2025 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA).
Ventris Medical Receives 510(k) Clearance for Innovative Backpack® Bone Graft Containment System
NEWPORT BEACH, Calif., Jan. 9, 2025 /PRNewswire/ — Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the United States Food and Drug Administration has granted 510(k) clearance for Backpack® (Porous Biologic Scaffold, K240765)). Backpack® represents a new class of biomaterials designed for the optimization of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures. Backpack® is available in 2 versions. One version consists of a collagen mesh pouch prefilled with our osteoinductive Allocell® AF fibers and in the second version, the collagen mesh pouch is prefilled with our surface activated Amplify® granules.