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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FDA MedTech

OTC hearing aid proposal, EtO sterilizer rule make 2020 regulatory agenda

Released on July 2, 2020

Dive Brief: A final rule from the EPA on commercial sterilizers that use ethylene oxide and an FDA proposal creating a […]

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FDA MedTech

FDA delays UDI enforcement amid COVID-19, ongoing technical issues

Released on July 2, 2020

Dive Brief: FDA has decided to delay the enforcement of unique device identification (UDI) requirements on Class I and unclassified products […]

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FDA Healthcare Telehealth

HHS ‘expects to renew’ COVID-19 emergency, spokesperson says

Released on June 30, 2020

Dive Brief: A top spokesperson for HHS tweeted Monday night the department “expects to renew” the public health emergency for COVID-19 […]

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Diagnostics FDA Healthcare

Beckman enters busy COVID-19 antibody test market amid accuracy concerns

Released on June 30, 2020

Danaher subsidiary Beckman Coulter has joined the ranks of major diagnostics manufacturers with FDA’s go-ahead to sell a COVID-19 serology test, […]

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