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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