The FDA Granted An Investigational Device Exemption To Initiate BACKBEAT Study Evaluating Orchestra Biomed's Atrioventricular Interval Modulation Therapy (BACKBEAT CNT) For Hypertensive Patients Who Are Indicated For A Dual-chamber Cardiac Pacemaker
Portfolio Pulse from Benzinga Newsdesk
The FDA has granted an Investigational Device Exemption to Orchestra Biomed for its BACKBEAT CNT therapy for hypertensive patients who are indicated for a dual-chamber cardiac pacemaker. This will allow the initiation of the BACKBEAT study.
September 19, 2023 | 11:38 am
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Orchestra Biomed's BACKBEAT CNT therapy has received an Investigational Device Exemption from the FDA, allowing the initiation of the BACKBEAT study.
The FDA's Investigational Device Exemption for Orchestra Biomed's BACKBEAT CNT therapy is a positive development for the company. It allows the initiation of the BACKBEAT study, which could potentially lead to the approval and commercialization of the therapy. This could have a positive impact on the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100