Cardiovascular Systems receives a CE mark; Cook Medical hit with warning letter;

@FierceMedDev: ICYMI yesterday: Spinoff Halyard Health gets boost from Ebola fears, stock up modestly in market debut. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Maryland provides seed financing to 15 med tech startups. Item | Follow @VarunSaxena2

@EmilyWFierce: This just in from the $ACT earnings call: "Actergan." | Follow @EmilyWFierce

> Cardiovascular Systems received a CE Mark for its Stealth 360 orbital atherectomy catheter treatment system for severe peripheral artery disease. News

> The FDA flagged device manufacturer Cook Medical with a warning letter about its Bloomington, IN, plant after below-par performance in a regulatory inspection last summer. More

> Developer of 3D scanning solutions, Fuel3D, closed a $6.4 million funding round that will be used to imove the company into the biometrics and eyewear markets, increase production, customer support and international retail distribution. Release

Biotech News

@FierceBiotech: Novartis gears up for FDA scrutiny with a new blood cancer drug. Report | Follow @FierceBiotech

@JohnCFierce: Should Chris Viehbacher replace John Lechleiter at $LLY? Now that would be interesting. | Follow @JohnCFierce

@DamianFierce: The most metal researcher in all of science. More | Follow @DamianFierce

@EmilyMFierce: Science Cafés are growing in popularity. More | Follow @EmilyMFierce

> GlaxoSmithKline heads to the FDA with its next big respiratory bet. Report

> AstraZeneca's $2B oncology contender shows promise in prostate cancer. Article

> Can Rockwell Medical win FDA approval for its dialysis drug? More

Pharma News

@FiercePharma: ICYMI: PATH Malaria Vaccines Initiative nets $156 million from Gates Foundation. FierceVaccines story | Follow @FiercePharma

@EricPFierce: Boehringer Ingelheim unloads US API plant to Chinese company even as it expands in China. FiercePharmaManufacturing article | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Here's a first: Regeneron cuts forecast after hard-charging Eylea sales miss. Article | Follow @CarlyHFierce

> Actavis rides success of branded drugs and M&A to positive Q3. More

> Allergan loses fight to block Ackman from voting for a Valeant takeover. Article

Drug Delivery News

> Distinct, compartmental reactions in an 'artificial cell' offer controlled delivery action. More

> OptiNose submits NDA to FDA. Item

> MIT spinoff SQZ Biotech nabs startup prizes for cell-squeezing delivery enhancer. Story

> AstraZeneca, University of Manchester create new center for advanced drug delivery. Article

> Study: Timing of administration an oft-overlooked factor in drug delivery. More

Diagnostics News

> Diagnostics companies homing in on rapid mobile tests to quell Ebola outbreak. Report

> Myriad signs expanded deal with AbbVie for cancer Dx. More

> AstraZeneca shells out $150M for cancer Dx outfit Definiens. Item

> LabCorp bets $6B in diversification deal with Covance. Story

> Qiagen beats the Street's Q3 numbers with success of companion Dx and next-gen TB test. Article

Pharma Marketing News

> Who's king of the orphan drug hill? BMS, Merck, Celgene and Roche, to name a few. Article

> A tale of two studies: Prescribe Pradaxa 'with caution'? Or rely on FDA's safety backing? More

> Sovaldi's not the only superhero launch: Meet the rest of the pharma Avengers. Story

> Sales speedster Eylea faces a tougher track in new DME market, Regeneron SVP says. Article

Suggested Articles

Qiagen launched a one-stop shop compiling publicly available genomic data, scientific literature and phenotypic information on potential superbugs.

Adaptive Biotechnologies is planning a $200 million IPO to help power its sequencing tests aimed at the body’s immune system and related therapies.

Abbott’s new diabetes test provides A1c results in three minutes, allowing clinicians to develop care plans within a single office visit.