FDA proposes quick response for 510(k) apps; Study: More than 1 in 7 TAVR patients suffer complications;

 @FierceMedDev: Roche Holdings' heart attack test helped reduce emergency room diagnoses in a new stud--via BloombergReport | Follow @FierceMedDev

 @MarkHFierce: Think an epipen, but shaped like a credit card that offers voice and written instructions. Sanofi made; FDA approved. More | Follow @MarkHFierce

 @DamianFierce: More M&A for Teleflex, this time spending $276M on Singapore's LMA. News | Follow @DamianFierce

> The FDA's proposed 510(k) guidance guarantees that devicemakers will get a response on their applications within 15 days. If the agency fails to do so, the application is automatically accepted for a substantive review. Report

> More than one in 7 patients undergoing transcatheter aortic valve replacement procedures reported major vascular complications, a study reports. News

> China's Dehaier Medical Systems reported flat income growth in Q2, netting $1.7 million on $7 million in revenue. Release

> Medical device manufacturer Helix Medical has acquired a 50% stake in Ireland's Cambus Medical, a maker of catheter components. Story

> Derma Sciences posted a net lost of $2.8 million in the second quarter, up from last year's $551,295, but the company saw its net sales jump 10.9% to $17.6 million. Item

> Medical Compression Systems, an Israeli firm developing a device to prevent blood clots after orthopedic surgery, snagged a $2.5 million investment from Pontifax. Article

Biotech News

 @FierceBiotech: On eve of Forest proxy showdown, Icahn takes aim at management for undisclosed FDA warning letters. Article | Follow @FierceBiotech

 @JohnCFierce: Booming Shire closes in on new campus site for U.S. HQ. More | Follow @JohnCFierce

 @RyanMFierce: Quintiles, the big CRO, gets bigger via buyout of DNA sequencing and analysis shop Expression Analysis. News | Follow @RyanMFierce

> Genentech whistleblower suit claims execs dangerously rushed Pi3K study. Report

> Unconventional Kineta adds to its bankroll for autoimmune program. Story

Pharma News

 @FiercePharma: Merck KGaA's Rebif (for MS) and Erbitux (cancer) helped push Q2 sales past expectations. Weak euro helped, too. More | Follow @FiercePharma

> Icahn slams Forest for undisclosed FDA warning. News

> What are Avastin's chances in its next NICE review? More

> Pfizer, AstraZeneca strike $250M-plus deal for OTC Nexium. Article

Biotech Research News

> Gene offers tantalizing leukemia target. Story

> University of Cambridge debuts latest stem cell research institute. More

> Nanomaterial propels self-repair for damaged hearts. Article

Pharma Manufacturing News

> Internet drug dealer gets 10 years but feds want his Chinese boss. Story

> FTC says GPhA drug shortage plan avoids antitrust issues. More

> FDA asks Merck to make up for Sanofi cancer drug shortage. News

> Thieves target pharmacies, not trucks, in Mexico. Item

> More drugs for U.S. to come from Ranbaxy's Mohali, India, plant. Article

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