The FDA wants more details for Atossa's breast cancer Dx 510(k); Development of pediatric 3D prosthetic hand takes interesting turn;

@FierceMedDev: 1,000 people (and rising) are gearing up to sue Medtronic over its Infuse bone growth implant. More | Follow @FierceMedDev

@MarkHFierce: Uh-oh for Thoratec. Some heart pump safety troubles. Story via WSJ (sub. req.) | Follow @MarkHFierce

@GalenMoore: Upheld: Former Spectranetics CEO's conviction for lying to the feds over device smuggling allegations. Story | Follow @GalenMoore

@EmilyWFierce: GE Healthcare slapped with FDA's most serious recall for some of its infant resuscitation products. More | Follow @EmilyWFierce

> Atossa Genetics' 510(k) application for its ForeCYTE Breast Aspirator test has taken an interesting turn with the FDA requesting additional information about the product's development. Item

> TransEnterix, a maker of flexible surgical instruments and robotics, said its revenue dipped and net losses climbed during its fiscal 2013 fourth quarter. Item

> NuVu Studio in Cambridge, MA, wants students to develop a 3-D prosthetic hand for children. Story

> A North Carolina surgeon has developed a medical implant designed to trigger an orgasm for patients unable to achieve them. Clinical trials will begin later this year in Minneapolis. Story

Biotech News

@FierceBiotech: FDA rejects Eli Lilly's SGLT2 diabetes drug empagliflozin. More | Follow @FierceBiotech

@JohnCFierce: Analysts applaud as Bristol-Myers preps a PhIII study for PD-1 cancer combo. Editor's Corner | Follow @JohnCFierce

@DamianFierce: FDA rejects Lilly and Boehringer's diabetes drug (SGLT2-blocker) over manufacturing issue. Release | Follow @DamianFierce

@EmilyMFierce: This week's issue of FierceBiotech Research is out: Read | Follow @EmilyMFierce

> Biogen Idec buys into Eisai's BACE camp on Alzheimer's as drug race heats up. News

> Xoma drug fails to beat out a placebo in PhII osteoarthritis study. Article

Pharma News

@FiercePharma: With tough Japanese enforcers eyeing its Blopress marketing, Takeda chief admits missteps. Story | Follow @FiercePharma

@TracyStaton: This year's version of FiercePharma's most popular special report: The top 10 pharma companies by 2013 revenue. Report | Follow @TracyStaton

@EricPFierce: WSJ says Pfizer angling for OTC Lipitor. That will get generic drugmakers' notice. More | Follow @EricPFierce

@CarlyHFierce: Roche, by the way, was No. 3 when it comes to 2013 revenue - read more here and see the rest of the top 10. Report | Follow @CarlyHFierce

> Medicaid health plans demand state help to cover pricey new hep C drugs. Article

> Lilly's end of the road on Evista looms with FDA nod for Teva generic. News

Drug Delivery News

> AstraZeneca looks to pen injector approval to turn Bydureon diabetes sales around. Story

> Teva, Alexza launch inhaled schizophrenia, bipolar treatment in the U.S. News

> Neos collects $15.5 from private investors to bring ADHD extended-release option to market. News

> Study: In two-drug, HIV-preventing vaginal ring, only one drug does the job. Article

> New manufacturing technique offers tailored delivery nanoparticles made of iron, silver and silicon. Story

> Tattoo-mediated delivery offers possible treatment for sandfly-borne skin disease. Brief

Diagnostics News

> J. Craig Venter raises $70M for a gene-sequencing and therapeutic startup. News

> Sequenom counts on prenatal test growth to reverse its fortunes. Story

> Qiagen launches its HPV test in India with low-resource areas in mind. Article

> Biodesix's CE mark triggers wider access for its personalized lung cancer treatment Dx. Story

NEJM study scores Illumina prenatal test high for reducing false positives. Research

> CardioDx confronts tough reimbursement climate by touting cost-effective CAD test. Brief

Pharma Marketing News

> It's trial by fire for Zogenix, as painkiller Zohydro's launch meets public furor. Story

> Sanofi expands Kynamro marketing team to spark up sales. News

> Critics may play whack-a-mole on pharma's doctor-speakers, but the species lives on. Article

> Can Teva persuade payers that pricey long-acting Copaxone beats cheap generics? Article

> Aiming for big growth in top 5 meds, Bayer will stake an extra $600M on marketing, R&D. Story

> With tough Japanese enforcers eyeing its Blopress marketing, Takeda chief admits missteps. Brief

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