Companies

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.

CareFusion Corp. has announced an agreement in principle to resolve previously disclosed government investigations related to prior sales and marketing practices for its ChloraPrep® skin preparation product and its relationships with health care professionals.

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

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.

It’s interesting to see Edwards Lifesciences reporting a sales increase of over eight percent compared with a year ago (10% on constant currency basis), yet still sounding disappointed that it missed its projections. Looking forward it’s watered things down a bit too.

Covidien has voluntarily recalled certain Power Pac batteries for its Newport™ HT70 and HT70 Plus ventilators following customers reporting units alarming and switching to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

Consumer protection activist organisation, Consumers Union has urged the U.S. FDA today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.

Abbott has announced that the TECNIS® Toric 1-Piece intraocular lens has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.

Now we weren’t expecting that. With DePuy ASR trials there was a thought that it would be a matter of how much rather than whether there was an award or not. Seemingly not true as an Illinois jury finds in favour of the company and offers no settlement.

Boston Scientific Corporation has acquired the fiXate™ Tissue Band from Anulex technologies, Inc. The fiXate Tissue Band is a novel suturing device that is designed to enable quick and simple placement of a suture to help secure a spinal cord stimulator lead or pain pump catheter.

Thermo Fisher Scientific , a world leader in serving science, has agreed to acquire life sciences company Life Technologies Corporation for approximately $13.6 billion. Thermo expects the move will create the ultimate customer partner and enable it to expand more rapidly, especially in emerging markets.

Integra LifeSciences has initiated a voluntary recall of certain products manufactured in its Añasco, Puerto Rico facility between December 2010 and May 2011 and between November 2012 and March 2013. It seems the Company identified that there may have been deviations from approved processes in their production rather than any specific product-related issues, but the impact on the numbers is real enough for the company to be issuing warnings of revenue and profits notices.

Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Boston Scientific Corporation has received U.S. FDA approval for its Precision Spectra Spinal Cord Stimulator System. The company is now beginning a limited launch of what it says is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts.

Stryker’s Shapematch cutting guide was the subject of a company recall last November. Now the FDA has upgraded the recall to Class I status, indicating the high risk it has placed on use of the device.

Biomet sees revenue increases entirely due to the DePuy trauma acquisition. Net income increased year on year after exclusion of special items.