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Cardiovascular, BioWorld MedTech
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Corvia launches Interatrial Shunt Device trial using Physiq's biosensor

September 25, 2019
By Annette Boyle
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Corvia Medical Inc. is enrolling patients in a 100-site multinational study of its Interatrial Shunt Device that will measure traditional heart failure endpoints as well as biosensor data transmitted to the cloud for analysis by Napier, Ill.-based Physiq's artificial intelligence analytics. The trial will evaluate Tewksbury, Mass.-based Corvia's device in heart failure with preserved and mid-range ejection fraction.
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Sonivie's PAH treatment scores FDA breakthrough device designation

September 10, 2019
By Meg Bryant
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The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.
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