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Penumbra launches Lantern peripheral microcatheter
Penumbra said it launched its Lantern peripheral microcatheter and reported Phase IV data from a 100-patient trial of its Indigo peripheral thrombectomy device. The Lantern device won 510(k) clearance...
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Intuitive Surgical looks to expand its Sunnyvale campus
Robotic surgery industry leader Intuitive Surgical (NSDQ:ISRG) is looking to grow its Sunnyvale, Calif. campus by approximately 600,000 sq. ft, according to the Silicon Valley Business Journal. The...
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FDA releases February 2016 510(k) clearances
February 2016 510(k) Clearances 510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016. TOTAL 510(k)s THIS PERIOD 224 TOTAL WITH SUMMARIES 213 TOTAL WITH...
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Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Medtronic’s Resolute Integrity stent tops Abbott’s Xience in Propel all-comers study Results from the Propel all-comers trial comparing Medtronic‘s (NYSE:MDT) Resolute Integrity drug-eluting stent...
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Sterigenics acquires Nelson Labs
Sterigenics said yesterday it picked up microbiology testing service provider Nelson Laboratories for an undisclosed amount. Salt Lake City, Utah-based Nelson Labs provides microbiology testing...
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Stryker closes $1.3B Physio-Control deal
Stryker (NYSE:SYK) said today that it closed the $1.28 billion acquisition of automated external defibrillator maker Physio-Control from Bain Capital. Medtronic (NYSE:MDT) sold Physio-Control to Bain...
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MassDevice.com +5 | The top 5 medtech stories for April 5, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Bracco wins FDA nod for liver cancer microspheres
Bracco Diagnostics said yesterday it won FDA premarket approval for its Lumason ultrasound imaging agent, now indicated for use in ultrasonography of the liver for characterization of focal liver...
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Study: Proteus Discover boosts compliance, lowers BP & LDL | ACC 2016
Proteus Digital Health yesterday presented interim results from a study of its Proteus Discover for patients with uncontrolled hypertension and type 2 diabetes, claiming use of the system raised...
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EnteroMedics touts study showing improved weight loss in moderate obesity...
EnteroMedics (NSDQ:ETRM) today released data from the ReCharge study of its vBloc Neurometabolic Therapy in patients with moderate obesity, touting 74% greater weight loss with vBloc therapy compared...
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FDA, NIH propose new clinical trial protocol template for investigational...
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration and the National Institutes of Health (NIH) have jointly proposed a new template for clinical trial sponsors to use for submitting...
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Medtronic still unfazed by new inversion rules
Medtronic (NYSE:MDT) remains unfazed by the U.S. Treasury Dept.’s push to rein in so-called “inversion” mergers, which allow American companies to re-organized under foreign jurisdictions, after the...
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SurModics launches 1st-in-human trial for SurVeil drug-coated balloon
SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device...
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Edap seeks FDA nod for Focal One HIFU
Edap (NSDQ:EDAP) said today it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The company said...
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MC10 inks Japanese distro deal with Marubun for BioStamp
MC10 said today it inked a limited exclusive distribution partnership with Marubun Corp. to distribute its BioStamp products in Japan. The Lexington, Mass.-based company’s BioStamp sensor products are...
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Amid public feuds, NEJM finds itself under attack
by Charles Ornstein, ProPublica. The New England Journal of Medicine is arguably the best-known and most venerated medical journal in the world. Studies featured in its pages are cited more often, on...
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FDA releases March 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD March 2016 TOTAL 510(k)s THIS PERIOD 279 TOTAL WITH SUMMARIES 265 TOTAL WITH STATEMENTS 14 DEVICE: QuikRead go CRP,...
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Cadence expands cleanroom capabilities
Cadence announced today plans to enhance cleanroom capabilities in its Plymouth, Mass., and Santo Domingo, Dominican Republic-based facilities to expand support for medical device and life science...
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Eximo Medical’s hybrid catheter clears pivotal trial
Eximo Medical said a 20-patient pivotal trial in Europe, aimed at winning CE Mark approval there for its hybrid peripheral catheter, met its safety and efficacy endpoints. Rehovot, Israel-based Eximo’s...
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MassDevice.com +5 | The top 5 medtech stories for April 6, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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