MedTech News
inHEART receives FDA Clearance for advanced AI-Driven Software Module that optimizes the creation of 3D Models of the Heart
Solution uses fully automated AI segmentation to generate inHEART’s digital twin of the heart with greater speed and efficiency
Implantable sensor could lead to timelier Crohn’s treatment
Wireless sensors monitoring inflammation could prevent or limit damage to intestines
Intuitive lands FDA clearance for new da Vinci robot
The soft tissue robotics leader incorporated new features into the system, from tissue sensing feedback to a smaller size and more comfortable console.
Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site
Inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System.
Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent.
SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.
Ventris Medical Receives 510(k) Additional Clearance for Amplify® Standalone Bone Graft Putty
NEWPORT BEACH, Calif., March 13, 2024 /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 in the intervertebral disc space for Synthetic Bone Graft Putty (Amplify®). Amplify® represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation and is comprised of Amplify® biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. The device can be used either standalone or in combination with autograft bone (1:1 ratio) as a bone graft extender.