CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above.

Johnson & Johnson MedTech (NYSE: JNJ)+
announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter to treat AFib

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).

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.

Alleviant Medical announced today that it received FDA investigational device exemption (IDE) and breakthrough device designation for its atrial shunt.

AccurKardia announced today that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia detection software.

Insulin delivery technology developer CeQur today announced a significant funding round to support its commercialization efforts.

Francis Medical announced today that it completed an oversubscribed $80 million Series C equity financing.