Philips rolls out heart surgery imaging device; Chinese Dx market poised to explode;

 @FierceMedDev: Japan readies guidelines for Sequenom prenatal Down syndrome Dx. More | Follow @FierceMedDev

 @MarkHFierce: A Down syndrome Dx is about to hit the market in Japan with lots of restrictive guidelines to prevent misuse. More | Follow @MarkHFierce

 @DamianFierce: Dako has won FDA approval for its companion diagnostic for blockbuster hopeful Kadcyla. Article | Follow @DamianFierce

> Philips is launching a new surgical tool in the U.S. designed to produce a combined view of X-ray and 3-D ultrasound images of the heart, enabling surgeons to perform minimally invasive repairs of heart-disease-related damage. Story

> Switzerland's Endosense has bagged another $4.3 million tranche to support its catheter ablation treatment of cardiac arrhythmias, part of a $44.6 million Series C. More

> Roche ($RHHBY) Chairman Franz Humer, widely credit with spurring the drugmaker's commitment to diagnostics, announced he will retire in 2014. Article

> The Chinese diagnostics market is poised to explode, according to Lux Research, as the new government has pledged about $183 million to support development in the local industry. Report

> CircuLite has secured the FDA's blessing for a feasibility study of its Synergy Circulatory Support System, a minimally-invasive device designed to reverse the symptoms of heart failure. Release

> Millennium Healthcare has secured nationwide distribution for its Oral Diagnostics Biopsy test, a non-invasive biopsy can be used to rule out oral dysplasia or cancer. Item

> Kinetic Concepts is touting a new study that finds its ABThera wound closure performed better than standard treatment and saved patients money in the long run. News

Biotech News

 @FierceBiotech: Trending on GSK jumps new IT hurdles in 'real-world' test of blockbuster hopeful. Editor's Corner | Follow @FierceBiotech

 @JohnCFierce: Celgene buys into upstart's new approach to evaluating cancer drugs- $13M upfront for Presage, a Jim Olson startup. More  | Follow @JohnCFierce

 @RyanMFierce: With Humer stepping down, who should be Roche's next chairman? Seems unlikely to be CEO Schwan. Article | Follow @RyanMFierce

> Onyx maps fresh expansion for SF campus. Item

> Specialty med price shock rattles ill-equipped payers. Report

> Depomed slams brakes on hot-flash drug after FDA advisers vote to reject. Article

Pharma News

 @FiercePharma: No dice for proposed menopause meds at FDA. Reviewers say benefits of Depomed, Noven drugs are "marginal." Article | Follow @FiercePharma

> Longtime Roche chairman is stepping aside. Who's up next? Story

> Generics bite primary-care sales, but specialty drugs soar 18.4%. Report

Pharma Manufacturing News

> Endo expands, upgrades Qualitest plant. Article

> GSK sues Hospira over vaccine deal gone bad. More

> Capsugel bags Encap for lipid technology. News

Biotech Research News

 @EmilyMFierce: New target found for common pediatric brain tumor. Article | Follow @EmilyMFierce

> Sarepta reports promising preclinical results for antibioterrorism drug. More

> Misshapen chemo drug particles may be better at targeting breast cancer. Article

> Sequester cuts come down heavy on scientific, medical research. Story

> Mouse neurons live longer than the brains they came from. Item