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France’s Servier to face trial over Mediator weight-loss drug

Drug maker Servier and the French drug regulator will face trial over weight-loss pill Mediator, believed to have caused at least 500 deaths in one of France’s worst health scandals, the prosecutor’s office said.

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GE Healthcare Launches First-Ever Mammography System that Allows Patients to Control their Compression by Remote Control

GE Healthcare announced FDA 510(k) clearance of an industry-first, patient-assisted mammography device that literally puts women in control of their mammograms.

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Device maker Teleflex boosts urology business with NeoTract buy

Medical device maker Teleflex Inc. said on Tuesday it would buy privately held NeoTract Inc. to strengthen its portfolio of urology devices in its second billion-dollar deal in the past nine months.

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Noble Announces Global Collaboration with BD to Provide Advanced Patient Onboarding Solutions for Line of Safety and Shielding Systems

Noble, a leader in biopharmaceutical onboarding and device training, announced a global collaboration with BD (Becton, Dickinson and Company), a leading global medical technology company, for developing patient onboarding solutions including demonstration devices.

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InVivo Therapeutics Slashes 39 Percent of Jobs and Cuts Two R&D Programs in Restructuring

Despite a temporary halt of an experimental spinal cord implant trial following a patient death, InVivo Therapeutics is doubling down and focusing its financial resources on the treatment by initiating a strategic restructuring that includes cutting nearly 40 percent of its workforce.

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Medtronic misses revenue estimates, shares dip

Medical device maker Medtronic Plc reported Q1 fiscal 2018 revenue fell short of analysts’ estimates, hurt by lower sales in its diabetes-related device business.

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Flimsy evidence behind many FDA approvals

Many drugs granted accelerated approval and most high-risk medical devices approved by FDA lack clear evidence of safety and effectiveness, per JAMA reports.

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Amazon’s Possible Strategy for Breaking Into the $560 Billion Pharma Market

Goldman Sachs published a 30-page report on how Amazon could break into the prescription drug market. Written by five analysts, the report points out that although Amazon has not explicitly stated it is interested in entering the prescription drug market, it has developed the secretive 1492 group, which is reportedly working on medical devices, and hired Missy Krasner, former vice president and managing director of Box’s healthcare and life sciences group to head up its pharmacy group. Box markets cloud management products and services.

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Stimwave Receives FDA 510(k) Clearance for the First Full-Body MRI Scan Ready Wireless Peripheral Nerve Stimulator (PNS) System

Stimwave LLC received FDA 510(k) clearance for the first wireless, micro-technology neuromodulation device that can enable ongoing full-body MRI scans under certain scanning conditions for the relief of chronic peripheral nerve pain.

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FDA clears Optovue’s epi-mapping software

The FDA cleared Optovue’s epithelial thickness mapping software (epi-mapping) for quantitative measurements of the epithelial and stromal layers of the cornea.

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Boston Scientific Warns of Fluke Death Involving Its S-ICD Pacemaker

Boston Scientific called a single pacemaker-related death for its S-ICD implant a “fluke” that was the result of radiation corruption that negatively impacted the device’s memory.

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Takeda, BioSurfaces Announce Research Program

Takeda and BioSurfaces announced a deal to initiate a research program designed to develop innovative medical devices to treat patients with GI diseases.

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Siemens Breaks Ground on $300 Million Expansion in Walpole, Mass., Plans for 700 New Jobs

Siemens Healthineers broke ground on a $300 million expansion at its Massachusetts-based laboratory diagnostics, manufacturing and research and development facility. 

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Stryker awarded $248.7 million in patent case against Zimmer

A U.S. judge increased the amount medical device maker Zimmer Biomet Holdings Inc. must pay Stryker Corp. for infringing patents on a surgical cleaning wand to $248.7 million following a ruling by the U.S. Supreme Court.

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Interleukin Genetics Slashes 63 Percent of Workforce, Shuts Down Program and Mulls Sale

The struggling Massachusetts-based company terminated five employees, about 63 percent of its workforce, as a part of a cost-cutting effort. The job cuts leaves the company with three employees, according to the Boston Business Journal. Stock prices tumbled more than 50 percent after the company made the announcement, closing at 29 cents per share.

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FDA Approves VNS Therapy Treatment

FDA approved LivaNova’s VNS Therapy system in patients as young as 4 years of age with partial-onset seizures that are refractory to antiepileptic medications.

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DePuy Synthes Announces Acquisition of Sentio to Enable Innovation in Minimally Invasive Spine Surgery

DePuy Synthes Products Inc., part of the Johnson & Johnson Medical Devices Companies, announced today that it has acquired Innovative Surgical Solutions LLC, doing business as Sentio LLC.

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Medtronic deal with Aetna ties insulin pump payment to patient results

Medtronic Plc said it signed an agreement with health insurer Aetna Inc. under which payment for its insulin pump systems will be tied to how well diabetes patients fare after switching from multiple daily insulin injections.

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FDA Voice Blog: Fostering Medical Innovation – A Plan for Digital Health Devices

“FDA will soon be putting forward a broad initiative that is focused on fostering new innovation across our medical product centers,” according to Scott Gottlieb, M.D. Commissioner of the U.S. Food and Drug Administration. “I will have more to say on many elements of this initiative soon. However, today I want to focus on one critical aspect of this innovation initiative: A new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices.”

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Real-time glucose monitoring system approved in U.S., Europe

Smart Meter LLC received 510(k) clearance from FDA and CE Mark in Europe to market the company’s iGlucose Blood Glucose Monitoring System.

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