MedTech News
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.
Alleviant Medical wins FDA IDE, breakthrough nods for no-implant heart failure treatment
Alleviant Medical announced today that it received FDA investigational device exemption (IDE) and breakthrough device designation for its atrial shunt.
AccurKardia wins FDA breakthrough nod for hyperkalemia detection software
AccurKardia announced today that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia detection software.
CeQur raises $120M to support insulin delivery tech
Insulin delivery technology developer CeQur today announced a significant funding round to support its commercialization efforts.
Francis Medical raises $80M Series C for water vapor ablation tech
Francis Medical announced today that it completed an oversubscribed $80 million Series C equity financing.
Fire1 raises $120M for breakthrough heart failure management tech
Fire1 announced today that it completed a $120 million financing round to accelerate the advancement of its heart failure management system.
Introducing isaac by PreEvnt™ – Non-Invasive Blood Glucose Alert Device at the CES Digital Health Exhibit
OXNARD, Calif., Jan. 6, 2025 /PRNewswire/ — PreEvnt, a subsidiary of SCOSCHE Industries, a leading innovator of award-winning consumer technology will proudly unveil isaac* by PreEvnt at the Digital Health Exhibit at CES.
Medtronic gets CE mark for Harmony transcatheter pulmonary valve
Medtronic (NYSE: MDT)+
today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system