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Liquid biopsies dominate FDA's latest breakthrough device nods

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Liquid biopsy developers feature heavily in the latest round of FDA breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status for their blood-based cancer tests.
Natera disclosed two breakthrough designations for its Signatera molecular residual disease (MRD) test. The designations provide a boost to Natera’s efforts to develop the circulating tumor DNA test through phase 3 trials as a companion diagnostic to two cancer medicines.
Texas-based Natera framed the FDA designations, which bring the number of Signatera breakthrough statuses up to three, as a reflection of progress in its cancer biopharma business. The unit has signed $65 million in contracts over the past year. Natera is yet to win FDA approval but it performs the test as a CLIA-certified laboratory. ....

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BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure ...

BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure ...
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Marko Bagaric , Berlin Heals Holding , Drug Administration , University Of Vienna , Breakthrough Device Designation , Cardiac Microcurrent Therapy Device , Investigational Device Exemption , Early Feasibility Study , Berlin Heals , Medical University , பெர்லின் குணப்படுத்துகிறது வைத்திருத்தல் , பல்கலைக்கழகம் ஆஃப் வியன்னா , திருப்புமுனை சாதனம் பதவி , இதய மைக்ரோகாரண்ட் சிகிச்சை சாதனம் , பெர்லின் குணப்படுத்துகிறது , மருத்துவ பல்கலைக்கழகம் ,

Investegate |Berlin Heals Holding AG Announcements | Berlin Heals Holding AG: BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States

Berlin Heals Holding AG
BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States
BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States
BERLIN and ZUG, Switzerland, March 11, 2021 (GLOBE NEWSWIRE) BERLIN HEALS, a company developing novel life-saving treatments for heart failure, announced today that the US Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for its proprietary Cardiac Microcurrent Therapy Device ( C-MIC ). The C-MIC is an implantable device that delivers a constant but minimal electrical DC-current to the heart via two electrodes. Based on results of first-in-human studies in 2019/20, the C-MIC device has shown potential to become the first near-curative heart failure therapy. Berlin Heals, which has already launched a Euro ....

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Berlin Heals Holding AG: BERLIN HEALS Receive Breakthrough Device Designation from FDA for its C-MIC Heart Failure Device and Initiates Early Feasibility Study in the United States

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BERLIN and ZUG, Switzerland, March 11, 2021 (GLOBE NEWSWIRE) BERLIN HEALS, a company developing novel life-saving treatments for heart failure, announced today that the US Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for its proprietary Cardiac Microcurrent Therapy Device ( C-MIC ). The C-MIC is an implantable device that delivers a constant but minimal electrical DC-current to the heart via two electrodes. Based on results of first-in-human studies in 2019/20, the C-MIC device has shown potential to become the first near-curative heart failure therapy. Berlin Heals, which has already launched a European-wide CE-study, is now about to file an Investigational Device Exemption (IDE) - Application with the FDA for an Early Feasibility Study (EFS) to commence in the US later this year. ....

Kostenloser Wertpapierhandel , Marko Bagaric , Berlin Heals Holding , Drug Administration , University Of Vienna , Breakthrough Device Designation , Cardiac Microcurrent Therapy Device , Investigational Device Exemption , Early Feasibility Study , Berlin Heals , Medical University , பெர்லின் குணப்படுத்துகிறது வைத்திருத்தல் , பல்கலைக்கழகம் ஆஃப் வியன்னா , திருப்புமுனை சாதனம் பதவி , இதய மைக்ரோகாரண்ட் சிகிச்சை சாதனம் , பெர்லின் குணப்படுத்துகிறது , மருத்துவ பல்கலைக்கழகம் ,