FDA MedTech Robotics

ReWalk’s New CMS Code Could Change the Exoskeleton Market Forever

Released on July 23, 2020

In 2014, ReWalk Robotics won FDA clearance for the home use of its personal exoskeleton. But despite the clearance happening six […]

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Cardiology FDA Structural Heart

Boston Sci Wins Nod for Next Gen Watchman Device

Released on July 22, 2020

Boston Scientific has won a nod from FDA for the latest generation of the Watchman Left Atrial Appendage Closure (LAAC) technology. […]

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FDA Robotics Surgery

Johnson & Johnson to take its time on general surgery robot

Released on July 17, 2020

Johnson & Johnson (NYSE:JNJ)  has decided not to follow a 510(k) clearance pathway for its planned general surgery robot — with a […]

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FDA Robotics Surgery

J&J drops planned 510(k) for Verb-Auris general surgery robot, targets 2022 clinical trial start

Released on July 17, 2020

Dive Brief: Johnson & Johnson has changed earlier plans to seek U.S. marketing authorization for its robotic platform for general surgery […]

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FDA MedTech

FDA proposes BPH device trial guidance changes as market heats up

Released on July 14, 2020

Dive Brief: FDA has proposed changes to its guidance on the development of medical devices used to treat benign prostatic hyperplasia, […]

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Drug-delivery FDA MedTech

Abbott lays out plan for US study of FreeStyle Libre 3

Released on July 13, 2020

Dive Brief: Abbott has laid out plans to begin a U.S. study this month of the latest version of its glucose […]

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FDA MedTech

FDA plans to resume onsite inspections later this month

Released on July 10, 2020

FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted […]

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FDA Orthopedic

FDA clears new Baxter bone graft substitute

Released on July 10, 2020

Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft for bone growth and fusion. Deerfield, […]

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Digital Health FDA Neuro

Soterix wins IDE for depression treatment trial

Released on July 8, 2020

Soterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial of its tDCS-LTE) neuromodulation system. New […]

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Diagnostics FDA MedTech

FDA warns of false positives with BD coronavirus diagnostic

Released on July 7, 2020

Dive Brief: FDA raised concerns Monday about an increased rate of false positives associated with a BD test for the novel […]

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Cardiology FDA Pediatrics

Berlin Heart touts pediatric heart device post-approval performance

Released on July 3, 2020

Berlin Heart announced today that it completed the post-approval surveillance process for its Excor pediatric ventricular assist device (VAD). Post-approval surveillance is […]

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FDA Implantables MedTech

Envoy Medical Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant

Released on July 2, 2020

WHITE BEAR LAKE, Minn.–(BUSINESS WIRE)–Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, […]

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