Regulatory

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.

The first implants of a novel aortic stent graft for use where aneurysms include sidebranches, have been performed under a new FDA early feasibility pilot program, designed to encourage more early-stage clinical research on new medical devices.

CircuLite®, Inc. has announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY® Circulatory Support System. The results show clinically meaningful and sustained hemodynamic improvements, with a relatively low rate of adverse events when compared with larger support devices.

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.

The FDA is promising that its two day course will teach you about 5 new risk management tools and 4 emerging new standards to transform your risk management program.

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.

Cook Medical’s aspirations with its Zilver® PTX® drug-eluting stent have been somewhat dented temporarily by the need to voluntarily recall the device following problems with its delivery device.

Four class I recalls in three days! It looks like someone at the FDA has been catching up with the paperwork as these four old recalls have been ramped up to Class I status in an attempt to put them to bed. One even goes back to 2011.