Regulatory

Medtronic’s Arctic Front Advance™ Cryoablation System now delivers cold therapy to a larger area more evenly, the company claiming that this will aid cardiologists in delivering cardiac ablation therapy.

Germans medical device company Cerbomed GmbH has received CE mark clearance for the application of transcutaneous Vagus Nerve Stimulation (t-VNS) in pain relief therapy.

This time it’s the company’s Alaris drug pump, certain models of which are suffering gremlins sufficiently dangerous to warrant FDA issuing a Class 1 recall, implying there is a significant risk of adverse health consequences or death.

Covidien has announced that it is not only recalling all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU), but is in fact discontinuing the products.

The National Institute for Health and Clinical Excellence has published final guidance on a new medical technology device designed to be used during surgery. The guidance advises that the use of the Mega Soft Patient Return Electrode could help reduce the risk of localised burns during monopolar electrosurgery

Covidien is conducting a voluntary recall of certain production lots of the DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that contain DGPHP RFA High-Power Single Use Grounding Pads.

Covalon Announces FDA Clearance for SurgiClear™ Antimicrobial Silicone Wound Dressing (via PR Newswire) MISSISSAUGA, ON, Aug. 21, 2012 /PRNewswire/ – … continue reading “Covalon Announces FDA Clearance For SurgiClear™ Antimicrobial Silicone Wound Dressing”

Medtronic has announced CE mark approval for two new CRT devices which automatically adapt to patients’ electrical rhythms, improving response to life-saving therapy.

Abbott has announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has gained CE Mark approval for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries.

One specific LOT of Baxter’s sterile water for irrigation may be contaminated by a bacterium. As a precautionary measure the company is acting and UK’s regulatory body has issued a device alert calling for quarantining of identified product as further investigation is performed.

Based out of Shenyang, China, Neusoft Positron Medical Systems, a joint venture between Neusoft Medical Systems Co., Ltd., and Positron Corporation has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for the Attrius® PET Systems.

EndoStim B.V. has announced CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter muscle.

W L Gore’s Hybrod Vascular Graft was FDA cleared two years ago, and now the company has announced it has its CE Mark, which it expects will bring a new level of utility to Vascular Surgeons in Europe.

Are the summer doldrums a good time to bury bad news or an opportunity to get your story to the top of the editor’s “hmmm interesting” list? We ponder this and other matters in our weekly View From The Med.

FDA has issued updated guidance on the clinical management of problematic Riata and Riata ST ICD leads. We take a considered look at how patients must be feeling and how well they’re getting looked after through this whole stressful experience.

As is often the case a company’s voluntary recall has morphed into the FDA Class 1 variety. This time it’s Covidien’s Shiley Adult Tracheostomy Tubes which have reportedly suffered disconnection and leakage.