FDA MedTech

Big data, cybersecurity among top FDA device center priorities

Released on August 23, 2019

Leveraging big data and real-world evidence in regulatory decisions, enhancing medical device cybersecurity and streamlining clinical trial design are some of the top priorities identified…

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Healthcare MedTech

AdvaMed warns White House sterilization regs pose device shortage risk

Released on August 23, 2019

AdvaMed warned the White House in a meeting August 8  that forthcoming regulations revising emission standards for ethylene production could endanger the medical device supply chain and patient safety if…

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Digital Health

AllScripts touts deal with Apple Health Records

Released on August 23, 2019

Apple has entered into an agreement with Allscripts to allow its Apple Health Records product to interface with many of Allscripts’ electronic health record products…

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Diagnostics Healthcare

Medicare draft decisions may boost Natera, Myriad tests

Released on August 23, 2019

Medicare contractors published a batch of local coverage determinations Thursday relating to devices and diagnostics sold by companies including Myriad Genetics and…

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Biotech

Enable Injections inks deal with Genentech

Released on August 23, 2019

Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device…

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Cardiology FDA

Edwards Lifesciences slides after FDA slaps Class I on Sapien 3 Ultra recall

Released on August 23, 2019

Edwards Lifesciences (NYSE:EW) shares slid today after the FDA slapped Class I status on last month’s recall of its Sapien 3 Ultra…

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Ophthalmology

New World Medical Launches Implant to Treat Moderate and Severe Glaucoma

Released on August 23, 2019

The Ahmed ClearPath device, named after the Rancho Cucamonga, CA-based company’s founder Dr. A. Mateen Ahmed, helps drain intraocular pressure…

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MedTech

5 More Private Medtech Companies to Watch

Released on August 22, 2019

MedTech analysts continue to keep a watchful eye on the private sector. Needham & Co.’s Mike Matson just called attention to these five private medical device companies he finds interesting, adding to two previous lists the firm published earlier this year…

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Cardiology FDA

FDA grants breakthrough nod to Miracor Medical’s PiCSO device

Released on August 22, 2019

Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of…

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MedTech

Industry sounds alarm on EU single-use device reprocessing regs

Released on August 22, 2019

The medical device industry strongly criticized aspects of the European Commission’s draft policy on the reprocessing of single-use products in a slate of comments on the proposal this week…

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Diagnostics FDA Cleared

Drawbridge Health Receives FDA 510(k) Clearance for OneDraw™ A1C Test System

Released on August 22, 2019

MENLO PARK, Calif., Aug. 22, 2019 /PRNewswire/ — Drawbridge Health today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the…

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Biotech

The anti-aging drug that’s just around the corner

Released on August 22, 2019

In 1999, the US Food and Drug Administration approved rapamycin as an immunosuppressant to prevent the rejection of…

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AI Cardiology

AI Finds Hidden Atrial Fibrillation in Subtle Beats of the Heart

Released on August 22, 2019

Atrial fibrillation, the fleeting arrhythmia of the heart, is hard to catch. Elusive and intermittent, it’s often overlooked during a seconds-long electrocardiogram …

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MedTech

Italy’s IMQ fourth notified body designated in EU

Released on August 22, 2019

Italian certification company IMQ is the fourth notified body designated under the European Union Medical Device Regulation, according to the European Commission Tuesday…

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Public Offering Vascular

Avinger prices $5m offering

Released on August 22, 2019

Avinger (NSDQ:AVGR) yesterday priced a stock offering worth nearly $5 million for its line of devices to treat…

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MedTech

Oral Surgeons in Manchester, CT Offer the First and Only FDA-Cleared Robotic Device for Dental Implant Surgery

Released on August 22, 2019

Esteemed oral surgeons in Manchester, CT, Drs. Rosenlicht and Ansari offer Yomi® Robotic-Assisted Implant Surgery to enhance their dental implant placement…

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Cardiology

Experts Caution Against Catch-all Assumptions About LVADs and Mitral Regurgitation

Released on August 22, 2019

Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create significant regurgitation, but a new study questions the presumption that all’s well with the mitral valve after…

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Orthopedic

Myomo launches OUS licensing development program

Released on August 22, 2019

Myomo today said it launched a business development program to help bring its MyoPro orthotic product line to more markets…

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Robotics Surgery

Medtronic Drops Huge Update on Surgical Robotics System

Released on August 22, 2019

Analysts and investors will get their first look at Medtronic’s soft tissue surgical robotics system late…

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Digital Health Wearables

Singapore taps Fitbit for nationwide public health program

Released on August 22, 2019

Singapore has enlisted Fitbit as a partner on a population health initiative meant to help improve overall health outcomes for the…

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AI MedTech

You and Artificial Intelligence

Released on August 21, 2019

Medical devices are getting smarter. Contracting executives will have to do the same…

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Orthopedic Spine

NuVasive launches Modulus TLIF-A porous titanium implant

Released on August 21, 2019

NuVasive (NSDQ:NUVA) yesterday announced the commercial launch of the Modulus TLIF-A, used in…

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Biotech FDA Approved

Teva launches generic EpiPen Jr.

Released on August 21, 2019

Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available…

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Digital Health Wearables

AliveCor stops selling KardiaBand ECG for Apple Watch

Released on August 21, 2019

AliveCor reportedly yesterday said that it ended sales of its KardiaBand for use with the Apple Watch…

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Imaging

Ultrasound firm Terason partners with DiA Imaging Analysis

Released on August 21, 2019

Ultrasound imaging company Terason said today that it has inked a deal with y DiA Imaging Analysis to provide DiA Imaging’s cardiac solutions on…

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Neuro Ophthalmology

Optic Nerve Stimulation Device Could Provide Visual Aid for Blind People

Released on August 21, 2019

Researchers at Ecole Polytechnique Fédérale de Lausanne in Switzerland have developed a new type of intraneural electrode to bypass the eyeball and send messages directly to…

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Radiology

High-Performance Handheld Ultrasound Based on Piezoelectric Micromachined Ultrasonic Transducers

Released on August 21, 2019

The company EXO Imaging out of Redwood City, CA recently emerged from stealth mode to announce the development of a novel technology called Piezoelectric Micromachined Ultrasonic Transducers (pMUT) for…

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