Maquet Cardiovascular wins approvals for new balloon catheter; Is medical device study data as good as companies believe?;

 @FierceMedDev: Hospira faces a Class I recall for its Symbiq infusion system. More | Follow @FierceMedDev

 @MarkHFierce: Drug eluting stents have benefits in people over age 80, acc. to the XIMA study. More | Follow @MarkHFierce

 @DamianFierce: Patheon is spending $255M on softgel specialist Banner Pharmacap. More | Follow @DamianFierce

> Maquet Cardiovascular nailed down both FDA 510(k) clearance and a CE mark for a new intra-aortic balloon catheter. Release

> ANSR is contemplating its future now that a federal judge ordered it to stop selling an anti-acne medical device and the FDA warned it has not properly sought FDA clearance for its products. Story

> IBA and Philips Healthcare ($PHG) have installed their first U.S.-based patient-centered proton therapy treatment room. Item

> Ascendx Spine, a Florida startup focused on designing devices to treat vertebral compression fractures caused by osteoporosis, is trying to raise $2 million, MedCity News reports. Story

> A number of makers of dissolving stents presented encouraging data at the Transcatheter Cardiovascular Therapeutics meeting in Miami, MedPage Today reports. Story

> Forbes magazine analyzes whether medical device companies are deluding themselves into thinking that their research data is better than it actually is. Analysis

Biotech News

 @FierceBiotech: Human heart simulated on world's fastest supercomputer. More | Follow @FierceBiotech

 @JohnCFierce: Survey: Many docs will be slow to switch to biosimilar mAbs. More | Follow @JohnCFierce

 @RyanMFierce: Five3, maker of cancer genomics software, takes off from UCSC labs. More | Follow @RyanMFierce

> Principia platform earns $12.5M tranche from A-list venture players. News

> GSK antes up Viiv stake, grabs control of potential HIV blockbuster. Story

Pharma News

@FiercePharma: Pfizer won't report earnings on Tuesday as planned, thanks to Hurricane Sandy. More | Follow @FiercePharma

> Pfizer reps to bear brunt of Canadian layoffs. Story

> Canada joins in on Novartis vaccine suspension. News

> Docs say they'll wait and see before using biosimilar mAbs. Item

> New AZ chief gets $6.4M to make up for Roche forfeit. Article

CRO News

> Patheon buys softgel specialist for $255M. Item

> Small CROs band together to better compete. Story

> Clinipace raises $9M to staff up after acquisition. Article

> Quintiles eyes first global trial for Indonesia. News

Biotech IT News

> Five3, maker of cancer genomics software, takes off from UCSC labs. News

> Human heart simulated on world's fastest supercomputer. Article

> Swedish bioinformatics group grabs $840K to fuel growth, report says. Story

> Accelrys acquisition hunt continues with $30M Aegis deal. Item

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