Biotronik wins FDA signoff for implantable defibrillators; CareFusion updates ventilator recall issue;

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@MarkHFierce: Two U.S. insurers will now cover MDxHealth's prostate cancer Dx test--a major win. It's hard to get coverage. Press release | Follow @MarkHFierce

@MichaelGFierce: MIT nanoparticles help deliver vaccines to mucosal surfaces. More from FierceDrugDelivery | Follow @MichaelGFierce

> Germany's Biotronik won the FDA's backing for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators. With that in hand, the company is launching its next-generation Ilesto DX platform. Item

> CareFusion said the company's voluntary recall of its AVEA neonatal ventilators due to a potential malfunction in high elevations now has a Class I status from the FDA--regulators' most serious designation. Item

> GE Healthcare ($GE) and The National Multiple Sclerosis Society will back an imaging study in patients with MS. Item

> If all else fails, supporters of repealing the 2.3% medical device tax might have better luck incorporating it into the broader debate over tax reform or in a form of Medicare-related legislation. Story

> Surgical device developer JustRight Surgical in Colorado raised $10.5 million in two recently completed funding rounds. Story

> Cerus ($CERS) said it has begun its FDA PMA application for the company's Intercept Blood System for platelets, which is designed to inactivate possible viruses, bacteria and parasites in donated blood. Item

Biotech News

@FierceBiotech: Most popular story on our website in Sept.: In big setback, GlaxoSmithKline's cancer immunotherapy MAGE-A3 flunks PhIII goal. Story | Follow @FierceBiotech

@JohnCFierce: Pretty clear that Perlmutter now becomes the head wheeler-dealer at Merck. Good role for him. Buying and selling. | Follow @JohnCFierce

@DamianFierce: Amid all this talk of axing jobs, have a look at FierceBiotech's rundown of just how much R&D chiefs get paid. Top 15 highest paid biopharma R&D chiefs | Follow @DamianFierce

> Serial NC startup team eyes another deal with latest biotech. More

> Struggling Merck slashing 8,500 jobs in major R&D, commercial reorganization. News

> Geron unloads its stem cell coffers to BioTime in stock deal. Story

> Shutdown looming, FDA approves new depression drug from Lundbeck, Takeda. Article

Pharma News

@FiercePharma: It's official: Roche's Perjeta nabs speedy  nod in early breast cancer. Kadcyla next? Story | Follow @FiercePharma

@CarlyHFierce: Bristol-Myers melanoma drug Yervoy helps patients live years longer, study finds. ICYMI yesterday | Follow @CarlyHFierce

> Lilly fails to persuade Medicare to pay for Alzheimer's imaging drug. More

> FDA approves Lundbeck, Takeda antidepressant Brintellix. Article

> Merck to slash 8,500 jobs in $2.5B global overhaul. Story

Biotech Research News

@EmilyMFierce: What happens to the FDA in a government shutdown? ICYMI from FierceBiotech | Follow @EmilyMFierce

> New approach could treat common childhood brain cancer. Report

> Antidepressants could provide new way to treat deadly lung cancer. More

> Antifungal drug abolishes HIV in cells. Article

> New approach could treat common childhood brain cancer. Story

> Evolva in talks with U.S. government for $14.7M antibacterial contract. Item

Pharma Manufacturing News

@EricPFierce: Growing Bayer HealthCare gets new leader. Pfizer exec Olivier Brandicourt takes over top job Nov. 1. ICYMI from FiercePharma | Follow @EricPFierce

> Legislation defines when FDA can take action against compounders. Story

> GSK opens $40M plant in Cork, Ireland, adding 20 jobs. More

> Merck joins Bahrain venture. News

> FDA plant inspections continue, even in government chaos. Item

> Boehringer Ingelheim Shanghai plant tripling capacity. Article