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Prescient Surgical wins de novo FDA nod for CleanCision surgical wound...
Surgical device spin-out Prescient Surgical said today it won de novo clearance from the FDA for its CleanCision wound retraction and protection system designed to cleanse and protect surgical wound...
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InVivo touts 6th patient conversion in regenerative spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that a patient enrolled in December in its Inspire study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. This...
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MassDevice.com +5 | The top 5 medtech stories for January 24, 2017
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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Study: DexCom touts low A1C, more “in range” time for MDI patients using CGM
DexCom (NSDQ:DXCM) today announced the publication of study results from a trial examining the benefit of continuous glucose monitoring for diabetes patients on multiple daily injections, touting...
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Stryker Q4 earnings take hit from recalled hip implants
Stryker’s profits decreased 2.3% year-over-year in the fourth quarter, to $510 million, amid charges related to its recalled Rejuvenate or ABG II modular metal-on-metal neck hip stems, as well as...
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Intuitive Surgical expects slowdown in da Vinci sales growth
Intuitive Surgical beat Wall Street expectations with its fourth quarter results, but company officials expect a slowdown in sales growth this year for da Vinci surgical robots. Intuitive Surgical...
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Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology...
Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to...
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Abbott’s Q4 sales miss the mark
Abbott (NYSE:ABT) missed expectations with its 4th-quarter sales but met Wall Street’s consensus forecast for earnings, sending shares down a tick in pre-market trading today. In its 1st quarterly...
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Heart Test Laboratories raises $12m to support heart disease detection device
Heart disease detection device developer Heart Test Labs raised $12 million in a private placement of common stock to support the international launch of its MyoVista product in the 1st quarter. The...
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Medtronic touts In.Pact Admiral drug-coated balloon data
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon in patients with peripheral arterial disease. The company presented outcomes from its In.Pact Global study patient cohorts...
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Abbott releases swath of BurstDR neuromod study data
Abbott (NYSE:ABT) this week released a wealth of new data on its neuromod technology, which it acquired in its $25 billion buy of St. Jude Medical (NYSE:STJ). Presentations included an analysis from...
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Vectura wins IND for drug-device combo for pediatric asthma
Vectura said yesterday that the FDA approved an Investigational New Device application for its drug-device combination to treat asthma in children 12 months to 8 years old. The UK-based company’s...
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Roche taps Vivonoetics, Great Lakes NeuroTech for wearable respiratory...
Roche (PINK:RHHBY) tapped Vivonoetics and Great Lakes NeuroTechnologies, to provide a wearable respiratory testing device to Roche’s Firefish study. The company’s study aims to evaluate drug efficacy...
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EU anti-trust regulators OK Abbott-Alere deal
Anti-trust regulators in the European Union may be OK with the pending, $5.8 billion union of Alere (NYSE:ALR), but Abbott (NYSE:ABT) still wants out of the deal. The Chicago-area healthcare giant,...
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Tracking the neurodegenerative disease haunting American football
Aethlon Medical (NSDQ:AEMD) subsidiary Exosome Sciences said today that it plans to support a clinical trial involving retired NFL players to study a biomarker-based diagnostic to detect and monitor...
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Report: Siemens to tap banks for Healthineers listing
Siemens (NYSE:SI) is reportedly ready to tap investment banks as it readies a public listing for its Healthineers business. Citing “3 people close to the matter,” Reuters said the German industrial...
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FDA approves 2mg Narcan nasal spray for opioid overdose treatment
Adapt Pharma said today that the FDA approved the 2mg formulation of its Narcan nasal spray for the emergency treatment of opioid overdose. The 2mg dose is intended for opioid-dependent patients that...
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How Howard Root guided Vascular Solutions to a $1B buyout—and beat federal...
Fink Densford/Associate Editor Fresh from a huge legal win over the U.S. Justice Dept., Howard Root guided Vascular Solutions to a $1 billion buyout. Here’s what he learned about leadership along the...
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PQ Bypass study meets safety, efficacy endpoints
PQ Bypass said yesterday that its Detour I trial met its primary safety and efficacy endpoints. The company’s trial is evaluating its fully percutaneous bypass treatment for patients with complex...
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Endologix wins CE Mark reinstatement for AFX, AFX2, touts 3-year post market...
Endologix (NSDQ:ELGX) said today it received notice that the CE Mark approval for its AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately, after being...
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