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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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Mazor Q2 tops The Street in EPS, falls short of rev
Mazor Robotics (NSDQ:MZOR) shares rose today after releasing 2nd quarter earnings that put the company above The Street’s expectations for earnings per share, but slightly behind on revenue. The...
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FDA warning letters: Findings for clinical investigators
Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the...
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DexCom shares droop on Q2 release
Dexcom Inc. (NSDQ:DXCM) released its 2nd quarter earnings late yesterday, nailing Wall Street analysts expectations for revenue but missing on earnings per share by nearly double, seeing shares shrink...
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Wright Medical surges on Street-beating Q2
Wright Medical (NSDQ:WMGI) saw shares surge over 10% after releasing 2nd quarter earnings that topped the Street in earnings per share but were off on revenue. The Memphis, Tenn.-based company reported...
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Reva Medical looks to CE Mark for Fantom scaffold
Reva Medical (ASX:RVA) said today it completed its submission for CE Mark approval of its Fantom sirolimus-eluting bioresorbable coronary scaffold following the completion of a clinical data analysis...
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LivaNova posts beat-and-raise Q2
LivaNova (NSDQ:LIVN) today posted Street-beating 2nd quarter earnings, raising its guidance and seeing shares rise over 10%. The U.K.-based company reported profits of $9 million, or 18¢ per share, on...
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