FDA

Misonix gains FDA clearance for ultrasonic surgical platform

Released on June 3, 2019

The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar…

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FDA Neuro

Israeli startup gets FDA nod for neuromodulation device to treat migraines

Released on May 30, 2019

According to research firm Global Data, the U.S. neuromodulation device market is expected to grow to …

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Biotech FDA

Resolution Bioscience Granted Breakthrough Device Designation from FDA

Released on May 30, 2019

Known as the Resolution HRD, the company’s liquid biopsy test promises to …

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Digital Health FDA

Nightware receives breakthrough designation for its PTSD nightmare therapy technology

Released on May 21, 2019

The startup’s Apple Watch application has received “breakthrough therapy” status from the Food and Drug Administration, expediting its clinical validation and review process…

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Cardiology FDA

FDA Says Patient Selection is Key to Abiomed Impella RP Safety

Released on May 21, 2019

The benefits Abiomed’s Impella RP System outweigh the risks of the device, but only if it is used for the currently approved indication…

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FDA

Report: AI-based med devices could leave makers liable for ‘learned’ changes

Released on May 17, 2019

A new push from the FDA for more artificial intelligence-powered devices could leave device makers liable for changes the devices ‘learn’ after their initial approval by the federal watchdog, according to a Bloomberg report…

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Cardiology FDA

New Approval Extends Impella’s Support Time

Released on May 14, 2019

Abiomed has received a nod from FDA to expand the Impella 5.0 and Impella LD PMA’s labeling…

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FDA MedTech

Regulation for AI-based medical devices could drive adoption

Released on May 7, 2019

In April, the Food and Drug Administration announced steps it’s taking to consider a new regulatory framework for AI-based medical devices…

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Cardiology Digital Health FDA

Medtronic gets FDA green light for iPad-based pacemaker programmer

Released on May 7, 2019

The FDA has cleared a new device manager platform from Medtronic that allows physicians to program and download data from compatible cardiac implants using an iPad…

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FDA MedTech

FDA Cracks Down on Surgical Staplers

Released on April 23, 2019

After analyzing more than 41,000 adverse event reports logged between January 2011 and March 31, 2018, FDA found that the most commonly reported problems involve…

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FDA

FDA explores changes to get better AI in medical devices

Released on April 23, 2019

The Food and Drug Administration wants public comments on how to overhaul approval of medical device software to better incorporate artificial intelligence tools…

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FDA

Ned Sharpless to continue where Scott Gottlieb left off at FDA

Released on April 17, 2019

Scott Gottlieb may be gone from the Food and Drug Administration, but his successor plans to continue the work he started…

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