UCLA docs find success with TransMedics' tech; 510(k) changes could increase costs;

 @FierceMedDev: New special report: Top 10 Diagnostics Companies 2012. Report | Follow @FierceMedDev

@MarkHFierce: Venture funding lives: TriReme Medical pulled in $18 million in a new round. Release | Follow @MarkHFierce

 @DamianFierce: As Mindray Medical knows, being a Chinese company gives you cost advantages but can come with some PR hurdles. More | Follow @DamianFierce

> UCLA doctors, using TransMedics' technology, for the first time successfully kept donor lungs functioning and "breathing" in an Organ Care System device as they were transported for lung transplant into a 57-year-old patient with pulmonary fibrosis. Story

> Beyond the 2.3% device tax slated to begin in January, device companies will also confront new changes in the 510(k) clearance process and a number of increased costs, Becker's Spine Review reports. Story

> The Wall Street Journal reports on the push to develop medical device implants powered by the body's own energy. Story (sub. req.)

> The U.K. government has awarded funding for development of a simple cancer diagnostic that tests blood to determine in real time how well a patient responds to cancer treatment. Release

> CardioDx, a 2012 Fierce 15 company, is launching a large-scale trial to compare diagnostic solutions for patients with coronary artery disease symptoms. More

> GE Healthcare ($GE) got 510(k) clearance for its FlightPlan liver imaging system. Article

> The FDA has launched a handy website that tracks all of its MDUFA-related proposed guidances. Item

Biotech News

 @FierceBiotech: In case you missed it: Top 50 Industry Voices in Biotech Twittersphere -- 2012. Special Report | Follow @FierceBiotech

 @JohnCFierce: Updated Acadia story with CEO comments on pimavanserin dev plans. Confirm Ph3, pursue schizophrenia and Alzheimer's psychosis. Story | Follow @JohnCFierce

 @RyanMFierce: Why Big Data alone lacks the punch pharma needs. Article | Follow @RyanMFierce

> China fosters biosimilar drug R&D with new set of custom guidelines. More

> Pfizer gets Rhythm with $8M bet on diabetes, obesity drug work. News

Pharma News

@FiercePharma: Merck KGaA says it won't offload its consumer health unit, despite promise of big $$. Report | Follow @FiercePharma

> Abbott nabs new Humira use, launches Amitiza in Japan. News

> Sharpening Victoza's edge, Novo touts data in trial against Januvia, Byetta. More

Pharma Manufacturing News

> Some 'misbranded drugs' turned up in Avastin probe came from Roche plant. News

> Switzerland, home of Roche and Novartis, gets pass from EU API rule. Story

> EMA wants manufacturers to offer up drug shortage 'risk analysis'. Article

> Novartis gets FDA OK for faster flu vaccine production at U.S. plant. More

Biotech Research News

> German team combines 2 old drugs for new MS treatment. More

> Stem cell-reliant HIV vaccine launches animal studies in January. Article

> Anti-cancer virus could gain new power with patient immune cell tweak. Story

> McGill scientists link autistic behavior to brain protein mutation. Item

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