Guided Therapeutics seeks FDA meeting after 'non-approvable' letter; The Sorin Group gains regulatory nod for heart devices;

@FierceMedDev: Covidien bought Maya Medical, the maker of a renal denervation treatment, and barely acknowledged it. Item | Follow @FierceMedDev

> Guided Therapeutics wants to meet with the FDA to determine a path forward for approval for its LuVivia advanced cervical scan PMA, after regulators issued a "not-approvable" letter for the product. Release

> The Sorin Group obtained FDA approval for its Paradym RF implantable cardioverter defibrillators and cardiac resynchronization therapy devices. Execs are also launching the products commercially. Release

> EndoSphere has secured a new U.S. patent regarding its incisionless anti-obesity device technologies. Release

> Hitachi Medical Systems America, which makes diagnostic imaging equipment, has gained FDA clearance to market its new Echelon Oval 1.5T Ultra-Wide MR system. Release

> Abbott has launched its new FreeStyle InsuLinx Blood Glucose Monitoring System in Canada. The product is armed with an insulin calculator to generate suggested insulin doses. Release

> Startup Micro Interventional Devices has nailed down $500,000 in bridge financing to advance clinical development of its Permaseal device, designed to enable self-sealing, sutureless cardiac access and closure for various heart repair procedures. Release

Pharma News

 @FiercePharma: New DSM won't make grief an illness. Panel also cuts two proposed diagnoses: RE psychosis, anxiety/depression--NYT. Article | Follow @FiercePharma

> Lipitor copy powers a surge in Ranbaxy sales, profits. Report

> Advisory panels take up Gilead's Truvada, then Quad. More

> Senate probes ties among narcoticsmakers, pain organizations. Story

Biotech News

 @FierceBiotech: Third Rock's Levin calls for teamwork in personalized medicine by @DamianFierce. Report | Follow @FierceBiotech

 @RyanMFierce: GSK's pursuit of HGSI has gone hostile as Glaxo goes directly to HGS investors with $2.6B tender offer. News | Follow @RyanMFierce

> FDA advisers snub Regeneron drug for gout. News

> Support seen for U.S. plan to speed nods for 'breakthrough' drugs. Article

> GSK raises fists in $2.6B hostile bid for Human Genome Sciences. Report

Biomarkers News

> Targeted therapies need cost-effective biomarkers. More

> DNA changes could predict prostate cancer relapse. Article

> 15-minute test could tag Alzheimer's. Story

> Biosignatures fingerprint tuberculosis and sarcoidosis. Story

Drug Delivery News

 @DamianFierce: The coming onslaught of blockbuster knockoffs could be a huge opportunity for drug delivery firms. News | Follow @DamianFierce

> Charge-changing nanoparticles can help kill resistant bacteria. More

> pSivida gets U.K. nod for behind-the-eye treatment. Article

> Echo's trandsdermal tech gets positive results, TV time. News

> Patent cliff could create need for novel delivery tech. Item

> MonoSol, Midatech tout positive Phase I for insulin film. Story

And Finally... University of Washington scientists have come up with a type of surface that, once shaken, would move drops along specific paths in order to conduct medical and environmental tests. The finding is considered an important step in developing diagnostics small enough to fit into a person's pocket, Nanowerk reports. Story

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