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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Diagnostics Drug-delivery MedTech

Thermo Fisher projects 10% increase in Q2 sales

Released on July 6, 2020

Thermo Fisher Scientific (NYSE:TMO) announced today that it estimates revenue growth for its recently ended second quarter to total approximately 10%. Waltham, […]

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Diagnostics Healthcare Neuro

Forest Devices partners with Alberta Health Services

Released on July 1, 2020

Forest Devices announced that it entered into a partnership with Alberta Health Services (AHS) to improve healthcare delivery for stroke patients. […]

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Diagnostics FDA Cleared Radiology

Qure.ai Secures FDA Clearance for Head CT Scan Technology

Released on June 30, 2020

Qure.ai said it has received FDA clearance for its first head CT scan product. The San Mateo, CA-based company’s technology is […]

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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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Cardiology Diagnostics MedTech

Boston Scientific wins FDA clearance for insertable cardiac monitor

Released on June 29, 2020

Boston Scientific (NYSE:BSX) today said it received FDA 510(k) clearance for its Lux-Dx Insertable Cardiac Monitor System. The system is a long-term […]

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Diagnostics Digital Health Telehealth

Verily, CVS Health join the budding back-to-work health screening market

Released on June 24, 2020

Verily and CVS Health are among the latest big names lending their health and technology expertise to reopening businesses. Both companies […]

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Diagnostics FDA MedTech

5-minute, quantitative COVID-19 antibody test snags BARDA backing

Released on June 24, 2020

Dive Brief: HHS’ Biomedical Advanced Research and Development Authority said Tuesday it is working with MBio Diagnostics on development of a […]

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Diagnostics FDA Healthcare

As problems grow with Abbott’s fast COVID-19 test, FDA standards are under fire

Released on June 24, 2020

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks […]

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Diagnostics M&A Oncology

Lantheus, Progenics complete merger

Released on June 22, 2020

Lantheus Medical Imaging (NSDQ:LNTH) parent company Lantheus Holdings announced the completion of its merger with Progenics Pharmaceuticals. Progenics, an oncology company developing medicines […]

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Diagnostics Healthcare

Verily’s COVID-19 community testing project now reaches 130 cities nationwide

Released on June 18, 2020

Verily announced that its COVID-19 testing program has been expanded to more than 130 cities and towns across the U.S. and […]

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Diagnostics MedTech

TÜV SÜD becomes 4th notified body designated under IVDR

Released on June 18, 2020

Dive Brief: The European Commission has designated a fourth notified body under the forthcoming regulations on in vitro diagnostics, per an […]

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