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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 ....

United States , Marko Bagaric , Berlin Heals Holding , Drug Administration , University Of Vienna , Breakthrough Device Designation , Failure Device , Initiates Early Feasibility Study , Cardiac Microcurrent Therapy Device , Investigational Device Exemption , Early Feasibility Study , Berlin Heals , Medical University , Investegate Announcements , Investegate Company Announcements , Berlin Heals Holding Ag , Globe Newswire , Globenewswire And , ஒன்றுபட்டது மாநிலங்களில் , பெர்லின் குணப்படுத்துகிறது வைத்திருத்தல் , பல்கலைக்கழகம் ஆஃப் வியன்னா , திருப்புமுனை சாதனம் பதவி , தோல்வி சாதனம் , இதய மைக்ரோகாரண்ட் சிகிச்சை சாதனம் , பெர்லின் குணப்படுத்துகிறது , மருத்துவ பல்கலைக்கழகம் ,

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 ,

Berlin Heals Holding AG: BERLIN HEALS Announces results of first-in-human study for its Implantable C-MIC device for the Treatment of Heart Failure with Electrical Microcurrent and the Launch of a pivotal CE Mark Study

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BERLIN and ZUG, Switzerland, March 04, 2021 (GLOBE NEWSWIRE) BERLIN HEALS, a company dedicated to developing and offering novel and life-saving treatments for patients suffering from heart failure, announces results of a first-in-human study published in
ESC Heart Failure, in patients with dilated cardiomyopathy for its proprietary C-MIC device. The C-MIC is a small implantable device that delivers a minimal constant electrical DC current to the heart. The results show significant, rapid improvements in heart function, heart size and quality of life of patients. Thus, this treatment has the potential to become the first sustainable, almost curative, treatment for heart failure in patients with unmet medical needs. ....

Kostenloser Wertpapierhandel , Marko Bagaric , Berlin Heals Holding , York Heart Association , New York Heart Association , Ventricular Assist Devices , Berlin Heals , Scientific Director , பெர்லின் குணப்படுத்துகிறது வைத்திருத்தல் , யார்க் இதயம் சங்கம் , புதியது யார்க் இதயம் சங்கம் , பெர்லின் குணப்படுத்துகிறது , அறிவியல் இயக்குனர் ,