Products

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.

A recent Europe-wide survey of Anaesthetists, delivered by UK medical device research firm Creative Medical Research, claims to have revealed the views of the profession in relation to existing and future technologies.

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.

The UK’s Bourn Hall, the world’s first IVF clinic, is introducing a new technology that captures early embryo development on video and then provides detailed, objective information about size and growth. This information can be used by embryologists to help them decide which embryos have the greatest chance of becoming a baby when transferred to the woman’s womb.

Mitek Sports Medicine has unveiled the Healix 3.4mm Suture Anchor, its smallest dual-thread offering for rotator cuff repair. This coincides with the introduction of a new double-loaded minimally invasive partial thickness rotator cuff repair system, as part of its Healix Transtend™ Implant System.

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).

J&J division, Sedasys says its sedation system is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal-to-moderate sedation in defined patient groups undergoing colonoscopy and esophagogastroduodenoscopy procedures.

A second of the companies heading down the FDA’s new Early Feasibility Pilot Study route is Texan outfit BiO2 with its clever anti-embolic Angel Catheter. Strikingly, as the study gets the FDA’s nod to commence, the device is already on the market in Europe.

Balloon Aortic Valvuloplasty looks like it’s been getting some serious design input as InterValve comes up with a figure eight shaped balloon for optimal rapid dilation. Now the device has added to its CE mark with a US FDA 510(k) clearance to market.