NxStage wins CE mark for dialysis needle; ReShape completes enrollment for anti-obesity balloon trial;

 @FierceMedDev: Intersect ENT pulls in $30M Series D for sinusitis-implant sales push. More | Follow @FierceMedDev

 @MarkHFierce: Another successful post-marketing test will help fuel adoption of CardioDx's coronary artery disease Dx. News | Follow @MarkHFierce

 @DamianFierce: Despite the uptick in scrutiny, Indian clinical trial deaths were about the same in 2012 as in 2011. Story | Follow @DamianFierce

> Ocular Therapeutix submitted an FDA premarket approval application for Resure Sealant, an ophthalmic device designed to seal clear corneal incisions after lens implantation surgery. Release

> NxStage Medical won a CE mark in Europe for its OneSite single needle device for use with dialysis patients. Item

> Peru's regulators published draft regulations designed to revamp the country's device classification system. Item 

> ReShape Medical completed enrollment in a 326 person pivotal trial designed to test its intragastric balloon, which it bills as among the first non-surgical weight loss devices developed for the U.S. market. Release

> Stratasys, based in Israel and Minnesota, is developing a 3-D printer that can, in part, produce customized medical devices. Story

> The blog InventorSpot highlights some of the more unusual Japanese medical devices now in the market. Item

Biotech News

 @FierceBiotech: In case you missed it last week: Fierce's Top 10 Biotech Techies - 2013. Special Report | Follow @FierceBiotech

@JohnCFierce: Royalty offer of $6.5B for Elan is smart. Investors can choose cash or Kelly Martin? No brainer. Just sweeten and stir. News | Follow @JohnCFierce

@RyanMFierce: Genentech opens mobile app playbook for tablet fans. Story | Follow @RyanMFierce

> Merck KGaA reports another R&D setback with PhIII brain cancer failure. News

> Dynavax regroups after FDA turns thumbs down on hep B vaccine Heplisav. Story

Pharma News

@FiercePharma: Reckitt Benckiser's heroin addiction drug Suboxone gets 2 generic rivals, despite co's attempt to block them. More | Follow @FiercePharma

@EricPFierce: Qualicaps, which Mitsubishi is buying, is investing $26 million to expand a plant in North Carolina. Article | Follow @EricPFierce

@AlisonBFierce: The FDA rejected Dynavax's Heplisav, an adult hepatitis B vaccine, causing shares to slide as much as 38 percent. News | Follow @AlisonBFierce

> Pfizer eyes more Chinese partners to speed growth. Article

> Ranbaxy back in gear for generic Lipitor production. News

> Allergan CEO nabs 51% pay hike with $9.4M one-time bonus. Story

> Affymax, Takeda pull Omontys after 3 deaths. Report

CRO News

> Chinese CRO ShangPharma one step closer to going private. Item

> Moody's says Quintiles is worth $4B, but IPO price remains mystery. Story

> Lonza inks $6.9M stem cell supply deal with NIH. News

> After Warnex buy, Biotrial jumps into bioanalytics. More

> Indian clinical trial deaths unchanged from 2011. Report

Biotech IT News

> Genentech opens mobile app playbook for tablet fans. News

> Medidata grabs software deal with Purdue Pharma. Article

> Ex-Merck dreamer Friend sharpens open science nonprofit with 'competition' edge. Story

> Boost in sales, customers pumps up Medidata's 2012 revenue. More

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A startup has raised $12 million to fund its real-time system for monitoring patients undergoing dialysis at home and calling in complications.