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

Suggested Articles

Johnson & Johnson Vision announced that the worldwide president of its surgical business, Tom Frinzi, plans to retire at the end of this year.

Philips looked back on 15 years of data from one of its telehealth-equipped intensive care units, where centralizing operations reduced mortality.

Sanofi will look to pull back from its three-year-old relationship with Verily and their virtual diabetes clinic, Onduo.