FDA hits Accutron with Class I label over flowmeter recall; Abbott device revenues continue to slide;

 @FierceMedDev: The FDA has slapped its most serious label on Accutron's voluntary flowmeter recall. More | Follow @FierceMedDev

 @MarkHFierce: New device company Cibiem launches with $10M series A. More | Follow @MarkHFierce

 @DamianFierce: AstraZeneca's inked a deal with another CRO, picking Charles River to help speed along its pipeline. More | Follow @DamianFierce

> Earlier this month, Accutron launched a voluntary recall of some of its flowmeters, warning that they can release nitrous oxide when switched off, possibly leading to brain damage in patients. Now, the FDA has slapped its most serious label, Class I, on the recall. FDA notice

> Abbott Laboratories ($ABT) posted double-digit earnings growth in the third quarter, but the company's vascular device revenue suffered from declining demand for the Promus stent, falling 10.2% from the previous year. More

> As India considers changing its regulatory system for medical devices, the industry wants some sort of guidance document to inform its decision-making in the meantime. Story

> Ventus Medical has launched a starter kit for its Provent sleep apnea device, designed to ease patients into the tech's expiratory resistance therapy. Release

> McGill University scientists have concluded that hepatitis C rapid/point of care tests with fast turnaround times work as efficiently as conventional laboratory tests that take more time. The finding, they believe, could help better control the infection. Release

Biotech News

 @FierceBiotech: Scientists produced stem cells from cadaver scalp tissue. Item | Follow @FierceBiotech

 @JohnCFierce: Looks like Samsung is getting a taste of just how devilishly hard it can be to develop drugs. More | Follow @JohnCFierce

 @RyanMFierce: Charles River is touting a 3-year strategic deal with AstraZeneca, which is outsourcing across the globe. More | Follow @RyanMFierce

> Cebix gains $31M, new CEO as it preps for PhIIb diabetes study. Story

> FDA advisers back NPS Pharma's orphan bowel drug. Article

Pharma News

@FiercePharma: Our latest ranking: 10 Largest Settlements and Judgments. Includes those big state deals. More | Follow @FiercePharma

> Abbott's drug sales tick upward as AbbVie spinoff looms. Story

> Sanofi, Coca-Cola team up on 'Beautific' drinks. Article

> Pfizer's bid to forestall Chantix trial fails. News

Biomarkers News

> Gene variants increase bipolar risk. Article

> Protein marker could cut cost of cancer screening. More

> Gene variant in donated kidneys could mark survival. Report

> Endocyte uses vitamin receptor to tag lung cancer. Story

Drug Delivery News

> Simple anti-HIV vaginal ring delivers three months of protection. Story

> Over the moon? NASA develops motion sickness nasal spray. Item

> Why shape matters in gene delivery. More

> Hiding in plain sight: Using red blood cell proteins to deliver drugs. Article

> Unilife announces new eye delivery platforms. News

Suggested Articles

In an SEC filing, Baxter International disclosed that it may have overstated its income over multiple years, inflating it by about $276 million.

The FDA has given Grail a green light to conduct the interventional study, and it has begun enrolling participants through the company’s R&D partners.

Coronavirus may not require a front-line battle yet in certain places, but it’s still taxing public health officials preparing for a potential crisis.