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Breakthrough Device Designation
This page shows the latest Breakthrough Device Designation news and features for those working in and with pharma, biotech and healthcare.
Roche and Eli Lilly to collaborate on Alzheimer’s disease blood test
Roche’s Elecsys Amyloid Plasma Panel (EAPP) test, which has already been given breakthrough device designation in the US, would be an additional tool to determine whether symptomatic individuals should proceed
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Biogen and Alcyone Therapeutics partner in deal worth over $50m
ThecaFlex, an implantable medical device intended for subcutaneous delivery of ASO therapies into the intrathecal space, has already received a CE Mark in Europe and Breakthrough Device Designation from the US ... Biogen’s interim head of R&D, Priya
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Roche’s diagnostic test for Alzheimer’s receives FDA Breakthrough Device Designation
Roche’s Elecsys Amyloid Plasma Panel has received a Breakthrough Device Designation from the US Food and Drug Administration (FDA) for use in the treatment of symptomatic patients being assessed for ... These biomarkers can signal a need for further
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Grail’s multi-cancer blood test gets FDA breakthrough status
Could detect multiple cancers from single blood sample. Cancer diagnostics venture GRAIL has been granted an FDA breakthrough device designation for its lead multi-cancer detecting blood test. ... The FDA breakthrough status is a major milestone for the
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Breakthrough Device status for novel blood filtering immunotherapy
Novel technology aims to reactivate immune system in cancer patients. This year has seen the FDA grant a flurry of Breakthrough Device Designations, and the latest is from Immunicom and its ... The US regulator first launched the Breakthrough Therapy
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Morning brief: Sanofi's shaky start, pharma begins talks with UK government and more
Omeros gains second Breakthrough nod. Omeros has gained an FDA Breakthrough Therapy Designation for its OMS721 drug, a novel treatment for patients with high-risk hematopoietic stem cell transplant-associated thrombotic ... Meanwhile, yesterday also saw
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AI: the smart money is on the smart thinking
efficiently. The CTEPH Pattern Recognition Artificial Intelligence obtained FDA Breakthrough Device Designation in December 2018.
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