MedTech News

Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.
This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.

Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess™, its restorative vascular access conduit
aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel

Providence Medical Technology, Inc. Announces FDA Clearance of CORUS™ Navigation Access System for Use with Medtronic’s StealthStation™ Surgical Navigation in Posterior Spinal Fusion
The potential benefits of utilizing the CORUS™ Navigation Access System to perform a navigated CORUS fusion include:
> Enhanced accuracy and precision with surgical instruments and spinal implants, e.g., CAVUX FFS-LX.
> Improved visualization of the facet joints and other anatomical structures during procedures.
> Reduced risk of complications and shorter operative time.

FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials
With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.

New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation
Temporary vessel occlusion a growing practice for trauma patients.

Philips launches Duo venous stent system with FDA approval
Philips (NYSE: PHG) today announced the first implant of its Duo venous stent system following FDA premarket approval.

FDA clears clinical decision software from Getinge
Getinge announced today that it received FDA 510(k) clearance for its Talis +ACG (advanced clinical guidance) support software.

Avicenna.AI secures FDA clearance for AI detection of vertebral compression fractures
Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.