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June 2, 2020
Tissue Regenix Earns CE Mark for OrthoPure XT
The certification followed positive results from a three-year trial.
June 2, 2020
Feedback’s Bleepa Imaging Platform Receives CE Mark
“Bleepa is the only solution that can allow remote image interpretation at the scale required to meet the challenges created by the coronavirus crisis,” the company said.
June 2, 2020
U.S. Donates 1,000 Ventilators to Brazil
“The U.S. and Brazil will remain in close coordination in the shared fight against the coronavirus pandemic,” the White House said.

Research and Development

May 26, 2020
New Reagent Available to Support COVID-19 Diagnostics
May 25, 2020
New Reagent Available to Support COVID-19 Diagnostics
May 25, 2020
Device Consortium Requests Feedback on Real-World Evidence Framework for IVDs
May 22, 2020
Consortium Calls for Comment on Real-World Evidence Framework for IVDs
May 22, 2020
Fujifilm Begins Research on AI Tech for COVID-19 Pneumonia

Submissions and Approvals

June 2, 2020
Stryker’s N95 Mask Decontaminator Gets Emergency Use Authorization
June 1, 2020
Gynesonics’ Sonata System 2.1 Gets Green Light
June 1, 2020
Nexxt Spine’s ALIF and Lateral Lumbar Systems Cleared
June 1, 2020
FDA Approves Eli Lilly’s Alzheimer’s Diagnostic Agent
June 1, 2020
FDA Grants EUA for Quest Diagnostics’ At-Home COVID-19 Test