FDA Robotics Surgery

Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors

Released on December 4, 2019

First surgical robot to be granted Breakthrough Device classification BOSTON, Dec. 4, 2019 /PRNewswire/ — Vicarious Surgical Inc., the leading innovator in virtual […]

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FDA Neuro Ophthalmology

FDA grants breakthrough status to eye-tracking Parkinson’s test

Released on December 4, 2019

Dive Brief: Bethesda, Maryland-based eye-tracking technology developer RightEye received FDA’s breakthrough device for its test for Parkinson’s disease, the company said Tuesday. […]

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Cardiology FDA

FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted

Released on December 3, 2019

The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest […]

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FDA Neuro Ophthalmology

RightEye Has “Breakthrough” in Its Vision for Parkinson’s Test

Released on December 3, 2019

There could soon be an eye test to aid in the assessment of Parkinson’s disease. FDA has recently granted breakthrough device […]

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FDA MedTech

FDA seeks public input on pediatric device applications including ways to minimize burden

Released on December 2, 2019

Dive Brief: FDA is seeking comments from the public on information required for submitting medical device applications for pediatric populations. The […]

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FDA Women's Health

Report: More women harmed by medical devices than men

Released on November 30, 2019

This article has been updated with comments from the FDA and from Madris Tomes. A new investigation of FDA adverse event […]

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Cardiology FDA

Medtech in a Minute: LivaNova Nixes TMVR, FDA Tackles EtO, and More

Released on November 27, 2019

FDA Wants Medtech to Cut Back on EtO Use FDA is encouraging manufacturers to reduce the amount of paper included in […]

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Digital Health FDA Urology

Renovia Receives FDA OK for Next Generation Pelvic Digital Therapeutic

Released on November 25, 2019

Renovia has received a nod from FDA for a next-generation pelvic digital therapeutic. The Boston-based company said the Ieva device is […]

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FDA Spine

FDA clears Life Spine Longbow titanium lateral expandable spacer system

Released on November 25, 2019

Life Spine announced that it won FDA 510(k) clearance for its Longbow titanium lateral expendable spacer system. The Longbow system is the […]

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Cardiology FDA

Attune Pushing for New Label Indication

Released on November 22, 2019

Attune Medical is hoping to get a label expansion for its device to reduce thermal injury to the esophagus during cardiac […]

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Drug-delivery FDA

Medtronic warns patients of MiniMed insulin pump safety issue

Released on November 22, 2019

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- […]

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FDA Neuro

Axonics inks deal to supply SNM system to University of Tennessee Medical Center

Released on November 22, 2019

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it entered into an agreement to supply its r-SNM (sacral neuromodulation) system to the University […]

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