NeuroMetrix pain management device wins 510(k) clearance; Unannounced device inspections debut in China;

 @FierceMedDev: Cleveland Heart will use $30M in new investment to advance its artificial heart device. An LVAD is also in the mix. News | Follow @FierceMedDev

 @MarkHFierce: Doctors in Japan have implanted the first baby there with an artificial heart. Release | Follow @MarkHFierce

 @DamianFierce: Covidien is voluntarily recalling two models of tracheostomy tubes over leakage risks. Report | Follow @DamianFierce

> NeuroMetrix ($NURO) gained 510(k) clearance for its Sensus pain management system, according to an FDA posting. Story

> For the first time in Japan, doctors implanted an artificial heart in a baby. Berlin Heart's Excor ventricular assist device was used for the procedure, as a bridge-to-transplant. Release

> SurModics ($SRDX), a maker of in vitro diagnostics technology, will purchase up to $55 million of its stock through a modified "Dutch auction" tender offer. Release

> Medical device manufacturers in China risk facing new unannounced inspections, thanks to new regulations that kicked in on June 18. Story (reg. req.)

> Ikonisys has raised $1.4 million to help fuel development of disease and genetic disorder detection devices. Story

> Minnesota's ExoStat Medical is seeking $4 million in funding to help advance a hand-held device designed to measure CO2 levels under the tongue to diagnose septic shock. Item

Biotech News

 @FierceBiotech: Teva's MLK inhibitor blocks aggressive breast cancer in MSU study. Article | Follow @FierceBiotech

 @JohnCFierce: There's no question that AZ paid too much for MedImmune. The question now is whether MedImmune has built a valuable pipeline. More | Follow @JohnCFierce

 @RyanMFierce: Did the VCs get dissed again? Novartis backs UPenn's pioneering cancer immunotherapies. Article | Follow @RyanMFierce

> Industry Voices: Microbiome Therapies - Coming to a Clinic Near You. More

> Astellas Pharma axes Durham R&D site amid generics threat. News

> K-V Pharma travels bankruptcy route after suing FDA. Story

> FDA approves Sanofi's Zaltrap for colorectal cancer. More

Pharma News

 @FiercePharma: Chinese officials arrest 2,000 (brave, foolhardy, daft, choose your adjective) people in counterfeit-drug sting. News | Follow @FiercePharma

> SEC ropes Teva into pharma bribery probe. Story

> Aenova will aim for M&A under new private-equity owner. News

> Escalating problems culminate in K-V Pharmaceutical bankruptcy. More

> Generics posse threatens to overwhelm Singulair sales. Article

Biotech IT News

> Bayer boosts diabetes message with new blog. Story

> Accenture snaps up pharma software outfit Octagon. Article

> Qsymia approval process. Timeline

> AstraZeneca adopts search engine for scientists. More

> Medidata lands record $100M deal with a Big Pharma. Story

CRO News

> Accenture boosts clinical data offerings with Octagon buy. Article

> Halo buys Teva's Canadian plant, inks production deal. News

> Report: Weak rupee hampers Indian CRO sales. More

> House Dems look to boost trial safety for patients. Story

And Finally... High-tech medical equipment and devices are often left unused after donations to poor countries, because they're not designed to run in the settings they're sent to, according to a new report. Story

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