FDA could classify mesh devices as high risk; First patient enrolled in study evaluating ST segment monitoring technology;

> The FDA could classify mesh devices surgically implanted transvaginally as high risk, thus requiring more clinical data, according to documents released today. News

> The first patient in a study examining the safety and effectiveness of a ST segment monitoring feature in an implantable cardioverter defibrillator has been implanted with the investigational device in the U.S., St. Jude Medical ($STJ) said in a statement. St. Jude release

> France's Cerma has created the spin-off Cermavein, which will expand commercialization of the proprietary Steam Vein Sclerosis technology for endovenous thermal ablation. SVS is the only product designed to treat all types of varicose veins in a single session. Cerma release

> MedWaves has received the OK from South Korean authorities to import and sell its AveCure microwave ablation system and devices through a partner in that country. The system has successfully been used in more than 1,000 patients worldwide, treating lesions in bone, as well as the kidney, liver, lung and pancreas. MedWaves release

> Not many people have completed a swim across the English Channel.  But a recipient of an artificial disc developed by Medtronic's Memphis-based spinal and biologics unit recently did so. Article

And Finally... Can a novice physician learn to implant a pacemaker through a vein to save a patient with a deadly slow heart rate? With PacerMan, he or she might be able to do so. Story

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