Individuals With Uncontrolled Hypertension - FDA Adcomm Panel Just Supported Japanese MedTech's Blood Pressure Treatment Device
Portfolio Pulse from Vandana Singh
The FDA's Circulatory Systems Devices Panel has backed Recor Medical Inc and its parent company, Otsuka Medical Devices Co Ltd's (OTC:OTSKF) (OTC:OTSKY) hypertension treatment device, the Paradise Ultrasound RDN system. The panel voted unanimously in favor of the device's safety and majority in favor of its efficacy. If approved by the FDA, the device would be the first FDA-approved renal denervation device in the U.S. intended to reduce blood pressure in patients with uncontrolled hypertension.
August 23, 2023 | 1:34 pm
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POSITIVE IMPACT
The FDA panel's backing of Otsuka Medical Devices' hypertension treatment device could lead to FDA approval, potentially boosting the company's market position in the U.S.
The FDA panel's backing is a significant step towards FDA approval. If the device is approved, it would be the first of its kind in the U.S., potentially giving Otsuka a significant market advantage.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
POSITIVE IMPACT
The FDA panel's backing of Otsuka Medical Devices' hypertension treatment device could lead to FDA approval, potentially boosting the company's market position in the U.S.
The FDA panel's backing is a significant step towards FDA approval. If the device is approved, it would be the first of its kind in the U.S., potentially giving Otsuka a significant market advantage.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100