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Intact Vascular launches clinical trial of Tack system
Intact Vascular said today it launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s (NYSE:MDT) Admiral drug-coated...
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US FDA: 17 Medical devices accepted into expedited access program so far
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has accepted 17 high-risk and de novo medical devices into an expedited access program launched in 2015, according to the agency....
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Medella Health raises $1.4 million for CGM contact lens
Start-up Medella Health said last week it raised $1.4 million to fund its in-development smart contact lens designed to continuously monitor glucose levels and transmit glucose data to a mobile device....
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Software startup Valify raises $2m in Series A
Texas hospital-software startup Valify raised $2 million in a Series A round of financing, according to Xconomy. Dallas, Texas-based Valify produces software and analytics to improve hospital spending...
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Axonics wins CE Mark for SNM, touts cost-efficacy study
Axonics Modulation Technologies said today it won CE Mark approval in the European Union for its SNM sacral nerve modulation system and announced the publication of a cost-efficacy study of the device...
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Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint
Ocular Therapeutix (NSDQ:OCUL) today saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint. Bedford,...
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Zimmer Biomet reveals FDA warning letter
Zimmer Biomet (NYSE:ZBH) today revealed a warning letter it received in late may over non-conformities with good manufacturing practice requirements for its quality system regulation at its Montreal,...
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FDA clears Cereve sleep-aid device
Sleep-focused company Cereve said today it won FDA 510(k) clearance for its Cereve Sleep System device designed to reduce latency to stage 1 and stage 2 sleep for patients suffering from insomnia. The...
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ESC adds St. Jude’s CardioMems to guidelines for directed HF therapy
The European Society of Cardiology has added St. Jude Medical‘s (NYSE:STJ) CardioMems heart failure system to its guidelines as a “directed therapy management and monitoring tool for heart failure...
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GW Plastics Wins Plastics News’ 2015 “Sustained Excellence” Award
GW Plastics is pleased to announce that it has been selected as Plastics News’ “Sustained Excellence” award winner for 2015. This prestigious award honoring continued excellence in well- rounded...
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CSS to attend MD&M East in New York
CSS, an international manufacturer of precision metal parts and assemblies for leaders in the medical, aerospace, firearms and defense, and transportation industries, is pleased to announce it will be...
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Sunrise Labs welcomes Doug Browne and Dave Hibbard to the team
Sunrise Labs, an ISO-13485 certified medical device product development firm in Auburn, NH, is proud to announce the addition of two engineers in leadership roles; Doug Browne, Director of Mechanical...
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Vertera Spine touts 1st procedures with Cohere spinal fusion device
Vertera Spine said today that the 1st procedures using its Cohere cervical interbody fusion system were performed recently, with a full market release of the device on the horizon. The Cohere device is...
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Milestone Scientific touts CompuFlo trial completion, plans FDA submission
Milestone Scientific‘s (OTC:MLSS) said today it completed the pivotal study of its CompuFlo epidural computer controlled system, investigating the safety and efficacy of the epidural space verification...
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MassDevice.com +5 | The top 5 medtech stories for June 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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First Ray wins FDA nod for SpeedButton soft-tissue-to-bone attachment device
Startup surgical device developer First Ray said today it won FDA 510(k) clearance for its SpeedButton system designed to attach soft tissue to bone. The SpeedButton device attaches soft tissue to bone...
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Staying ontop of hydrocephalus shunt failure with ShuntCheck
Antonio Venus-Reeve, 14, had his first shunt surgery for hydrocephalus when he was 2½ months old. Born at 25 weeks’ gestation, weighing less than two pounds, he had a serious brain bleed seven days...
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NuVasive picks up neuro monitoring provider Biotronic NeuroNetwork for $98m
NuVasive Inc. (NSDQ:NUVA) said yesterday it bought intraoperative neurophysiological monitoring service provider Biotronic NeuroNetwork for $98 million in cash. Biotronic NeuroNetwork provides...
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Avita Medical signs Malaysian distro deal with Mintcare
Avita Medical (ASX:AVH) said today it inked a distribution deal with Asia-Pacific specialized wound care product distributor Mintcare. Through the deal, Mintcare will distribute Avita’s wound care...
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Zimmer Biomet to drop $1B on spine-focused LDR Holding
Zimmer Biomet (NYSE:ZBH) said today it is buying spinal medical device company LDR Holding for approximately $1 billion. Boards from both companies approved the acquisition agreement, the company said,...
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