Approval/Clearance

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.

Israeli company ETView has been granted US FDA 510(k) clearance for an expanded size range of its VivaSight™-DL Airway Management System. The company currently distributes the VivaSight™-DL Airway Management System in the US.

Dialysis device company NxStage® Medical, Inc. has gained FDA clearance for its System One™ hemodialysis system. The only truly portable hemodialysis system cleared for home use, System One with its new higher flow capabilities will be launched in the United States later this year.

St. Jude Medical, Inc. has announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P). The device brings quadripolar lead technology to the pacemaker market for the first time.

In short Last summer we announced the CE marking of Blockade Medical’s cerebral aneurysm coil system, here. Now the company … continue reading “FDA 510(k) Clearance For Blockade Medical™ Barricade™ Coil System”

Spinal device company Spine Wave, Inc.has received US FDA 510(k) clearance to market and sell the StaXx® IB System, an Intervertebral Body Fusion Device.

in vivo imaging company NinePoint Medical, Inc. has received an additional FDA 510(k) clearance for its NvisionVLE™ Imaging System, expanding the system’s indication to include imaging of esophageal tissue microstructure.

Olympus claims is fancy pants new 3D HD visualisation system improves speed, accuracy and precision of surgical procedures when compared with 2D surgical systems.

Interesting concept this. The Lifecare Keyhole Cup is a clear plastic dome that sucks in the anterior abdominal wall following application of negative pressure. This in turn separates the wall from the underlying tissues and provides a safe environment in which to insert the Veress needle prior to laparoscopic surgery. The cup is then removed.

Z-Medica® has gained expanded CE indications for its QuikClot® Hemostatic Dressings. QuikClot® products are now indicated as an adjunct to manual pressure for the temporary control of moderate external bleeding from surgical wounds or cuts and lacerations during operative and postoperative care.

It’s a form of ultimate recycling, fat tissue removed using Andrew Technologies’ HydraSolve device now being FDA cleared for reinjection into the same patient.

TriReme has announced that its Japanese partner, Century Medical, Inc. (CMI), has received Shonin approval for the Glider™ PTCA catheter indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion. Glider™ is the world’s only torqueable PTCA catheter and is designed to address challenging cases such as bifurcations and highly stenosed lesions.

Aspect Imaging has obtained clearance from US FDA for its M2 compact MRI system, developed for diagnostic imaging of the wrist. The company says its technology should deliver MR-based imaging at a fraction of the cost of existing clinical MRI systems.