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/PRNewswire/ -- Berlin Heals Holding AG (Berlin Heals), a Swiss medical technology company, is delighted to announce the appointments of Dr. Felix Baader and...
/PRNewswire/ -- Berlin Heals Holding AG (Berlin Heals), a Swiss MedTech company that has developed a completely new and groundbreaking method for the therapy...
Share it 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 t...
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 i...
(1) 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 the...