@FierceMedDev: EU proposes tougher medical device rules in light of breast implant scandal. More | Follow @FierceMedDev
@DamianFierce: Smith & Nephew has issued a device failure warning for one of its all-metal hip implants. More | Follow @DamianFierce
> The Affordable Care Act, bearer of the 2.3% excise tax, is said to be a blessing in disguise for the medical device industry, as expanding the ranks of the insured will mean more customers for devicemakers. However, according to a report from Roth Capital Partners, that claim's not all its cracked up to be. Analysis
> A California court has sided with the hospital board accused of conducting secret tests of a Stryker ($SYK) bone growth product, saying the hospital does not have to produce internal documents on the issue. News
> Startup Spiritus Tech has developed a cuff inflation syringe that addresses the risks of underinflation in endodtracheal intubations. Article
> Precision Spine snagged 510(k) clearance for its ReForm pedicle screw system, designed to stabilize spinal segments. More
> Advanced Brain Monitoring picked up FDA clearance for its neuro-cardio diagnostic tool, Sleep Profiler, which assesses sleep architecture and continuity. Item
> Dallen Medical is seeking an FDA nod for its Compressyn staple for small bone fixation, targeted to foot, ankle and hand applications. Release
> German medical device and component company Helix Medical is opening a new facility in Costa Rica. Release
Biotech News
@FierceBiotech: Tagging the lows: RNA biomarkers personalize depression treatment. More | Follow @FierceBiotech
@RyanMFierce: Ouch. Cardiome doesn't have much to fall back on after this Afib program that Merck has dropped back in its lap. More | Follow @RyanMFierce
> Biogen races to FDA with positive PhIII data for hemophilia B drug. Article
> FDA seeks ways to boost antibacterial drug pipeline. Story
> Merck hands back heart-drug rights to struggling Cardiome. Item
Pharma News
@FiercePharma: Did Valeant bid too high for Medicis? Analysts cite flagging scripts for lead drug, Solodyn. More | Follow @FiercePharma
> J&J aimed Risperdal pitch at childrens' doctors, witness says. Story
> Reckitt petitions FDA to force 'child resistant' packaging on Suboxone rivals. Article
> Is Valeant's $2.6B price for Medicis too high? More
Biomarkers News
> Marker picks out the right people for stroke therapy. More
> Genes power bowel cancer marker panel. News
> Cutting through the silence of heart disease. Article
Durg Delivery News
> Pulsing nanotubes pump out drugs. Story
> SkyePharma's Flutiform launches in Germany, Kyorin seeks OK in Japan. News
> Boston Scientific's stent opens blood vessels and European markets. Article