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StemCells to wind down operations after ending mid-stage study
(Reuters) – StemCells Inc said it would wind down operations after the company terminated a mid-stage trial testing its therapy in spinal cord injury, sending its shares plummeting 85%. The magnitude...
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Sensus Healthcare prices $11m IPO
Sensus Healthcare (NSDQ:SRTSU) priced an $11 million initial public offering yesterday, saying it plans to float 2 million shares at $5.50 apiece starting today. Boca Raton, Fla.-based Sensus said the...
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Brazilian regulators move to all-electronic medical device importation process
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA now accepts only electronic submissions of petitions for importation of devices. According to a new directive, RDC...
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Zoo’s Tasmanian Devil gets pacemaker
(Reuters) — A Tasmanian devil named Nick is back in his exhibit at the San Diego Zoo after receiving a pacemaker to make his heartbeat normal. In January, zoo veterinarians discovered that Nick...
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NeuroMetrix jumps on $21m round as Quell pain device hits 1k retail stores
NeuroMetrix (NSDQ:NURO) shares jumped yesterday after the company announced a $21 million private placement and said its Quell pain relief device is on the shelves at 1,000 retail drug stores. The...
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Judge: Plaintiffs must prove cases in Zimmer NexGen knee MDL
Plaintiffs in the multi-district litigation over the NexGen knee implants made by Zimmer Biomet (NYSE:ZBH) must prove their cases under a so-called “Lone Pine” order issued by the Illinois federal...
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Appeals court again upholds NuVasive in patent win over Medtronic
A federal appeals court today again upheld its decision to award a win to NuVasive Inc. (NSDQ:NUVA) in 1 of its long-running patent infringement battles with spine implant rival Medtronic (NYSE:MDT)....
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Noxilizer wins 510(k) for NO2 sterilization of medical device
Novel sterilization firm Noxilizer on Wednesday touted the FDA 510(k) clearance of a device which is terminally sterilized using the company’s nitrogen dioxide sterilization process. Read the full...
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Vital Connect raises $18m for wearable biosensors
Wearable biometric diagnostic patch company Vital Connect raised $18 million in a new round of equity financing, according to a new SEC filing. The company is developing the Vital Connect platform...
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MassDevice.com +5 | The top 5 medtech stories for June 3, 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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Tepha buys its way out of Metabolix bioresorbables deal
Absorbable biomaterial developer Metabolix said it amended its license agreement with medical device company Tepha, forgoing future royalties and providing 2 additional Metabolix production strains and...
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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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