Regulatory

Covidien’s Nellcor™ pulse oximetry systems have received U.S. FDA 510(k) clearance for so-called “motion” claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio.

Thoratec Corporation has received approval from the U.S. FDA to market the HeartMate II® Pocket Controller™, a device it calls the small, smart, safe face of the HeartMate II LVAD System.

Devon Medical, Inc. has received the CE mark for its portable extriCARE® 2400 Negative Pressure Wound Therapy (NPWT) system. NPWT has … continue reading “CE Mark For Devon Medical’s extriCARE® Portable Negative Pressure Wound Therapy System”

Tryton Medical, Inc., specialist in stents designed to treat bifurcation lesions, has gained CE Mark approval for its Tryton Side … continue reading “CE Mark For Next-Generation Tryton Side Branch SHORT Stent”

Biosensors International says its newly CE Marked BioMatrix NeoFlex™ drug-eluting stent builds on the strengths of its predecessor, but with enhanced pusability, trackability and crossability..

Direct Flow Medical Inc. has received FDA approval for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of its novel transcatheter aortic valve system. We’ll be watching to see whether this study replicates EU study results showing a reduction in valve regurgitation.

With EuroPCR* taking place any day, now seems a good time for companies to be previewing their offerings and debuting … continue reading “St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement”

Elixir Medical Corporation has received CE Mark approval for its DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System. The scaffold is designed to degrade in about one year returning the patients’ coronary vessel ultimately to its normal de novo state.

CircuLite®, Inc. has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of its SYNERGY® IC Circulatory Support System, the first mechanical support system that does not require major surgery.

DiFusion Technologies’ Xiphos ALIF spinal implant manufactured from VESTAKEEP® PEEK material has received FDA 510(k) clearance. The company says the material is ideally suited for use in an implantable spinal device with structural requirements.

Visiometrics has gained CE mark approval for the next generation of its Optical Quality Analysis System, the HD Analyzer. Launch follows.

Sorin’s next-generation implantable defibrillators can now be monitored remotely using the company’s Smartview technology which has now gained FDA approval.

Taking your dental technology and applying it to other surgical disciplines makes perfect sense if you’re to fully exploit your intellectual property. FDA’s clearance of WaterLase iPlus for surgical application means BioLase is not just a dental company any more.

The FDA has issued a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.

St. Jude Medical, Inc. has announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Two new devices from the Medtronic ICD/CRT-D stable have gained FDA’s approval. These are the Viva®portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).