Medical Devices: Page 153
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Telemedicine CEO pleads guilty in $424M Medicare kickback scheme
The executive admitted to seeking and getting bribes from patient recruiters, pharmacies and brace suppliers in return for arranging for doctors to order medically unnecessary orthotic braces.
By Dana Elfin • Sept. 9, 2019 -
Axonics wins PMA for sacral neuromod system, challenging Medtronic
The FDA approval allows the medtech to market its implantable, rechargeable device for treatment of fecal incontinence as it seeks further indications for overactive bladder and urinary retention.
By Maria Rachal • Sept. 9, 2019 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
NESTcc 1.0 aims to launch, be able to take unsolicited projects by end of year
The National Evaluation System for health Technology Coordinating Center Task Force is also currently developing an active surveillance roadmap it aims to issue for public comment this fall.
By David Lim • Sept. 6, 2019 -
FDA finalizes guidance on HDEs after AdvaMed scrutiny
Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.
By Susan Kelly • Sept. 6, 2019 -
Racing Edwards, Abbott starts pivotal trial of tricuspid device
The product, a sibling of MitraClip, could become the first transcatheter tricuspid device of its kind on the U.S. market.
By Nick Paul Taylor • Sept. 6, 2019 -
Jacob Bell/MedTech Dive
FDA floats idea for assessing the risk-benefit profile of weight-loss devices
Concerned that some patients lack access to effective weight-loss devices, the agency is seeking feedback to inform guidance that it says will help device developers offer a wider variety of tools.
By Nick Paul Taylor • Sept. 6, 2019 -
Livongo posts 'good enough' first earnings since IPO, but stock tanks
The digital health company beat analysts' revenue targets, but a greater-than-expected loss on earnings per share contributed to a double-digit hit to its stock price in morning trading.
By Maria Rachal • Sept. 5, 2019 -
With partner iRhythm, Verily ramps up AFib efforts
iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.
By Maria Rachal • Sept. 5, 2019 -
Robotic tech used for cardiac intervention from 20 miles away
Patients were treated remotely using telerobotic technology from Corindus, which was recently acquired by Siemens Healthineers.
By Nick Paul Taylor • Sept. 5, 2019 -
More Blue Cross plans now covering Senseonics' implantable glucose monitor
The medtech recently snagged a new positive coverage decision from Health Care Services Corporation, the nation's fourth largest insurer, which operates Blue Cross Blue Shield plans covering 16 million members across five states.
By Nick Paul Taylor • Updated Oct. 15, 2019 -
Tool to bust coronary plaque with sonic waves wins FDA breakthrough nod
Shockwave Medical, which went public in March, is enrolling patients in a pivotal trial to study the device in treating cardiovascular disease. Abiomed is among its backers.
By Susan Kelly • Sept. 4, 2019 -
Stryker spends up to $500M to boost spine unit with imaging, robotics tech
The medtech said Monday it completed its buy of Mobius Imaging, which makes a mobile CT scanner, and Cardan Robotics, which develops radiology procedure technologies.
By Maria Rachal • Updated Oct. 21, 2019 -
Biotronik's Orsiro stent beats Abbott's Xience in head-to-head trial
The trial linked the "ultrathin" Orsiro to a lower rate of target lesion revascularization than Abbott's incumbent device.
By Nick Paul Taylor • Sept. 4, 2019 -
FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel
The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.
By David Lim • Sept. 3, 2019 -
Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests
Published in JAMA and funded by Medtronic, results from the retrospective study have yet to be confirmed by randomized clinical trials.
By Maria Rachal • Sept. 3, 2019 -
Regulators put out call for experts to join device advisory committees
FDA is seeking people to sit on 18 panels that review medical device data and manufacturing regulations.
By Nick Paul Taylor • Sept. 2, 2019 -
FDA urges providers, manufacturers to transition to duodenoscopes with disposable parts
Boston Scientific told investors last year single-use duodenoscopes represent a market opportunity of more than $1 billion dollars.
By David Lim • Aug. 30, 2019 -
Jacob Bell/MedTech Dive
Summer slowdown drags on for De Novos
The FDA has not announced a De Novo clearance in 12 weeks. Two-thirds of the way through 2019, pacing suggests the overall number of novel device approvals won't match 2018's high.
By Maria Rachal • Aug. 30, 2019 -
McKesson, Philips devices flagged by DHS for cyber vulnerabilities
Certain cardiovascular IT systems and ultrasound devices could be exploited by hackers, the Department of Homeland Security wrote in separate notices.
By Nick Paul Taylor • Aug. 30, 2019 -
AdvaMed wins some, loses some in FDA guidance on managing uncertainty
While the agency tweaked parts of the document in line with feedback from AdvaMed and other groups, it maintained its plan to hold advisory committee meetings on certain postmarket data and kept other contested proposals.
By Nick Paul Taylor • Aug. 30, 2019 -
Medline, Vantage ethylene oxide emissions caused cancer, lawsuits claim
Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.
By David Lim • Aug. 29, 2019 -
Surmodics passes milestone in trial of Abbott-licensed paclitaxel-coated balloon
Surmodics completed enrollment sooner than some analysts expected on a trial comparing its paclitaxel-coated balloon to Medtronic's IN.PACT Admiral.
By Nick Paul Taylor • Aug. 29, 2019 -
Elekta buys ProKnow to boost digital radiotherapy strategy
The Swedish company says ProKnow's capabilities are of particular value to its large customers, potentially helping give it an edge over rivals such as Varian Medical Systems.
By Nick Paul Taylor • Aug. 29, 2019 -
Life Spine talks up global expansion weeks after DOJ hit
The micro invasive spine tech maker says its products are now sold in 30 countries, including recent additions in South America.
By Nick Paul Taylor • Aug. 29, 2019 -
Medtronic's Ishrak set to retire after nearly decade as CEO
The leadership shuffle paves the way for Restorative Therapies Group head Geoff Martha, who led Medtronic's nearly $43 billion takeover of Covidien in 2014, to take the helm in time for the medtech giant's next fiscal year.
By Maria Rachal • Aug. 28, 2019
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