MedTech News
.................... by Andrew Celentano
Elixir Medical’s coronary bioadaptor system granted FDA breakthrough device designation
The designation recognises the novelty of the technology and the potential to provide a more effective treatment option for patients with coronary artery disease.
CardioFlow’s VitaFlow Liberty™ Granted EU CE-MDR Mark, Advancing Global Expansion Roadmap
SHANGHAI, June 17, 2024 /PRNewswire/ — MicroPort® CardioFlow Medtech Corporation (CardioFlow) (Stock Code: 02160.HK) recently announced that its self-developed second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow LibertyTM Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow LibertyTM), has received EU CE-MDR certification. This certification highlights VitaFlow LibertyTM as a pioneering TAVI solution, that sets a new benchmark in transcatheter heart valve treatments.
Philips wins FDA nod for new mobile C-arm
Philips (NYSE:PHG) announced today that it launched its now FDA-cleared Zenition 90 motorized mobile C-arm system.
A new way to spot life-threatening infections in cancer patients
Leuko, founded by a research team at MIT, is giving doctors a noninvasive way to monitor cancer patients’ health during chemotherapy — no blood tests needed.
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.