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Essential Medical wins FDA IDE nod for vascular sealer
Essential Medical said today it won an Investigational Device Exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device. The 180-patient pivotal study will run across 10-16 sites...
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Invuity prices $28m offering
Invuity (NSDQ:IVTY) last week priced a new $28 million public offering of common shares, looking to float $2.8 million shares at $10 a piece. The new offering comes with a 30-day underwriters option to...
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MassDevice.com +5 | The top 5 medtech stories for August 1, 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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Cantel Medical picks up Accutron for $52m
Cantel Medical (NYSE:CMN) said today it acquired Accutron for approximately $52.5 million. Accutron manufactures nitrous oxide delivery systems and single-use nasal masks, and will be folded into the...
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Medpace prices $161m IPO
Contract research organization Medpace today released the pricing for its initial public offering, looking to float 7 million shares at between $20 and $23 per share, which will bring in between $140...
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ReVision Optics touts Raindrop inlay study data
ReVision Optics today released results from a trial of its Raindrop near vision inlay, touting significantly improved near and immediate vision and no loss of distance binocular acuity in subjects with...
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Piloting an improved intercenter consult process
By: Michael Rappel, Ph.D., and Rachel E. Sherman, M.D., M.P.H. Over the last few months, we’ve shared what FDA is doing to improve the review of combination products, including establishing the...
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Gore wins FDA nod for Tigris vascular stent
W.L. Gore & Associates said today it won FDA premarket approval for its Tigris self-expanding vascular stent designed for treating peripheral artery disease. The 3rd-generation dual-component stent...
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Boston Scientific issues urgent field safety notice for select Lotus valves
Boston Scientific (NYSE:BSX) this week issued a voluntary field safety corrective action for its Lotus Valve Systems, looking to recall units from the field over issues with release mandrel breakage....
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TransEnterix sells 1st ALF-X unit
TransEnterix (NYSE:TRXC) said today it sold the 1st ALF-X surgical robotic system to Milan, Italy’s Humanitas Hospital. The company acquired the Telelap ALF-X robot-assisted surgery device from Italy’s...
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SteadyMed raises $32m
SteadyMed Therapeutics (NASDAQ:STDY) today announced a new $32 million round of funding through a 2-tranche private placement. The round was led by new investor OrbiMed and joined by existing investors...
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Glaukos raises guidance after Street-beating Q2
Glaukos (NYSE:GKOS) today released 2nd quarter earnings that topped The Street’s expectations for earnings per share and revenue marks, lifting its full year 2016 revenue expectations. The Laguna...
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Few seniors seeking health advice from Dr. Google
(Reuters) – Even though most seniors have cell phones and computers, they still don’t go online to find answers to medical questions, contact doctors or fill prescriptions, a U.S. study suggests....
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Draeger Medical wins $57m contract from DoD
Draeger Medical reeled in $57.4 million from the U.S. Department of Defense, according to a contract release posted yesterday. The money came through the 2nd 1-year option period for a 1-year base...
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Nu-Med Plus tweaks NO delivery system pre-FDA 510(k) submission
Nu-Med Plus said today it is making tweaks to its delivery system prior to applying for FDA 510(k) submission. The Salt Lake City, Utah-company said it is incorporating its newly developed nitric oxide...
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ImpediMed, Mayo Clinic ink dev deal
Australian medtech developer ImpediMed said last week it inked a 3-year joint development deal with the Mayo Clinic. ImpediMed develops and distributes medical devices which use bioimpedance...
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Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath
Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s...
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MassDevice.com +5 | The top 5 medtech stories for August 2, 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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J&J’s Codman Neuro inks distro deal with InNeuroCo
Johnson & Johnson‘s (NYSE:JNJ) Codman Neuro said last week it inked an exclusive U.S. and European distribution deal with InNeuroCo for its intermediate catheters designed for the minimally...
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Remote heart monitoring can help detect emergencies
(Reuters) – Instead of having heart monitors with noisy alarms near patients’ beds in the hospital, it might be better to have off-site technicians do the heart monitoring remotely, a recent study...
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