Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site
March 15, 2024
Inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System.
Inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System.
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent.
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.
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.
Announcing a new type of diagnostic platform that uses sound waves to spin an individual drop of water up to 6,000 revolutions per minute.
The collaborators aim to resolve the clinical, regulatory, coverage and payment questions facing developers of the devices.
Affluent Medical today announced the successful first-in-human implant of its minimally invasive urinary incontinence treatment device.
Applied during endoscopic procedures, GastroShield could help prevent complications such as bleeding and leakage from weakened gastrointestinal tissues.
With the new technique, MIT researchers hope to identify mutations that could be targeted with new cancer therapies.