Abiomed completes enrollment in new Impella heart pump study; China is tightening its med device regulatory enforcement;

@FierceMedDev: Corning leads NinePoint's new $34M Series B--a big round for the next-gen imaging tech developer. More | Follow @FierceMedDev

@MarkHFierce: This is the kind of pacer I'd like to try. Wild stuff. Feature via PopSci | Follow @MarkHFierce

@MichaelGFierce: Drug delivery in space? NASA contributes to the field with microcapsules developed by ISS Research. More via FierceDrugDelivery | Follow @MichaelGFierce

@EmilyWFierce: Congress wants more answers from the FDA about its regulation of mobile medical apps. Story | Follow @EmilyWFierce

> Abiomed ($ABMD) has completed enrollment in an IDE study for its Impella RP percutaneous heart pump. Release

> ProTom International in Texas gained 510(k) clearance for a new proton therapy device to treat patients with cancer. Release

> China is tightening its medical device regulatory supervision and enforcement. Item

> Medrobotics in Massachusetts gained a CE mark approval for its new robot-assisted surgical device designed for otolaryngology surgery. Story

> A group of UCSF researchers has come up with a wireless device that can be inserted into a pregnant woman's vagina and send an alert when premature labor may be happening. Story

Biotech News

@FierceBiotech: Biotechs bag $170M in IPO cash as a booming quarter winds down. Article | Follow @FierceBiotech

@JohnCFierce: Sanofi launches a vaccine R&D program with blockbuster Prevnar 13 in its sights. News | Follow @JohnCFierce

@DamianFierce: Liver risks put another Geron trial on ice, but the damage has largely been done already. More | Follow @DamianFierce

@EmilyMFierce: Survey: 1 in 5 Americans think doctors know vaccines cause autism. Story via FierceVaccines | Follow @EmilyMFierce

> GlaxoSmithKline's cancer vaccine MAGE-A3 suffers its second PhIII flop. More

> Sanofi launches a vaccine R&D program with blockbuster Prevnar 13 in its sights. Coverage

Pharma News

@FiercePharma: Pay-for-delay: Is cash the only antitrust test that matters in patent settlements? Story | Follow @FiercePharma

@TracyStaton: Should gastro specialist Salix snap up Furiex and its IBS drug candidate? More | Follow @TracyStaton

@EricPFierce: Even an OTC drugmaker can have research published in New England Journal of Medicine. News | Follow @EricPFierce

@CarlyHFierce: Valeant's CEO, a crackerjack cost-cutter, seeks more 'fat' companies to buy. Piece | Follow @CarlyHFierce

> J&J blazes a new pharma trail with industry's first designer-in-chief. Article

> AstraZeneca unveils direct-to-patient Nexium sales to fend off generic rivals. More

Pharma Manufacturing News

> Novartis CEO predicts generic industry fallout as quality takes center stage. Story

> FDA jumps compounder for making unapproved domperidone. News

> FDA cuts U.S. plant inspections while boosting them overseas. Story

> Indian regulator finds number of substandard drugs on the rise. Article

> Parexel opens Singapore distribution facility. Story

> OTC maker has discovery published in New England Journal of Medicine. Brief

Vaccines News

> Novartis to submit Bexsero to FDA in Q2. News

> 1 in 5 Americans think doctors know vaccines cause autism. Survey

> Amgen posts positive PhIII data as judgment day for cancer vaccine bet nears. News

> Failure of sexual health clinics to offer HPV vaccine leaves high-risk groups vulnerable. Story

> Circassia begins trading in London following successful IPO. News

> Sanofi inks a Korean alliance to develop a pneumococcal vaccine. Brief

Suggested Articles

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.

Flatiron has hired a new chief medical officer as it looks to push on under its new parent in the world of electronic health records and real-world data.