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DoD re-ups Philips contract for $77m
Royal Philips (NYSE:PHG) won a maximum $77 million modification through the U.S. Department of Defense as the 7th year in a possible 9-year contract for medical equipment. The contract positions...
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Summer 2016 enforcement date set for Chinese medical device clinical trial rules
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) plans to begin enforcing new clinical trial quality management requirements for medical devices starting June 1, 2016....
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Zimmer Biomet says federal probe to extend past deadline
Zimmer Biomet (NYSE:ZBH) said last week that the U.S. Justice Dept.’s probe into alleged Biomet kickbacks schemes in Brazil and Mexico will extend past the deadline of a deferred prosecution agreement...
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BioTelemetry ponies up $16m for VirtualScopics
BioTelemetry (NSDQ:BEAT) said last week that it agreed to pay about $15.5 million to acquire clinical trial imaging provider VirtualScopics (NSDQ:VSCP) with an all-cash tender offer. Terms of the deal...
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Glaukos wins Japanese nod for iStent glaucoma device
Glaukos (NYSE:GKOS) said today that the Japanese Ministry of Health, Labor & Welfare approved its iStent device for treating glaucoma. Laguna Hills, Calif.-based Glaukos said the approval covers...
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Intuitive Surgical touts cost study on robot-assisted prostate surgery
Intuitive Surgical (NSDQ:ISRG) is touting a study comparing the cost of prostate surgery using its da Vinci robot-assisted surgery device with traditional open surgery. The study, published in the...
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V-Wave touts 1st-in-human for interatrial shunt
V-Wave today released results from the 1st-in-human implantation of its investigational interatrial shunt device designed for patients with advanced heart failure, touting a 100% success rate for...
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Direct Flow launches next-gen TAVI delivery system in the EU
Direct Flow Medical today announced the European launch of its next-gen DirecTrack Delivery System designed for its Direct Flow transcatheter aortic valve system. The new system features improved...
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Anika Therapeutics wins CE Mark for Cingal knee treatment
Anika Therapeutics said today it won CE Mark approval in the European Union for its Cingal drug-combo designed to treat osteoarthritis-related knee pain. Cingal is a combined viscosupplement formulated...
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Rock West Medical Devices raises $1.3m
Rock West Medical Devices said in a regulatory filing that it raised $1.25 million from a single, unnamed investor. San Juan Capistrano, Calif.-based Rock West Medical is a subsidiary of Rock West...
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Stentys wins CE Mark for Xposition S self-apposing coronary stent
Stentys SA (EPA:STNT) said today it won CE Mark approval in the European Union for its self-apposing coronary Xposition S sirolimus-eluting stent, claiming it to be the “world’s 1st and only...
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Former Advanced BioHealing exec Clawson pleads guilty in VA fraud case
Former Advanced BioHealing executive Todd Clawson last week pleaded guilty to federal charges that he bribed U.S. Veterans Affairs Dept. doctors to use the company’s DermaGraft biologic wound dressing....
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ECRI, LSE partner for medical device pricing study
The ECRI Institute said earlier this month it inked a partnership deal with the London School of Economics and Political Science’s LSE Health and Social Care group. The Plymouth Meeting, Penn.-based...
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MassDevice.com +5 | The top 5 medtech stories for March 28, 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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Japan clears Zoll’s Thermogard XP for sudden cardiac arrest
Zoll Medical said today its Japanese Subsidiary Asahi Kasei Zoll Medical won approval from Japan’s Pharmaceuticals and Medical Devices Agency for its Thermogard XP temperature mangement system for...
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AHA: Wearable defib may be alternative to ICD for select patients
Wearable automatic defibrillators may be a viable alternative to implantable cardioverter-defibrillators in patients at risk for life threatening heart rhythm abnormalities, according to the American...
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Addressing issues relating to combination products: Human factors
By: Jill Hartzler Warner, J.D., and Thinh Nguyen Combination products represent an important and growing category of therapeutic and diagnostic products under the FDA’s regulatory authority. These...
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Tegra Medical receives Manufacturing Excellence Award from Worcester Business...
Tegra Medical is proud to announce that it has received the Manufacturing Excellence Award from the Worcester Business Journal. The eight recipients of this inaugural award were announced in its March...
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FDA clears Corindus Vascular Robotics CorPath for peripheral interventions
Corindus Vascular Robotics (NYSE:CVRS) said today that it won FDA 510(k) clearance for its robotic-assisted CorPath system for peripheral interventions, a year after launching a clinical trial. The...
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Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers. Broomfield, Colo.-based...
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