Regulatory Setback For Medtronic's High Blood Pressure Device - FDA Backed Japanese Firms' Similar Device For Uncontrolled Hypertension
Portfolio Pulse from Vandana Singh
Medtronic's Symplicity Spyral RDN System, a device for treating high blood pressure, has faced a regulatory setback as the FDA Circulatory System Devices Panel voted against its approval, citing that the risks do not outweigh the benefits. Meanwhile, the same panel backed a similar device by Recor Medical and its parent company, Otsuka Medical Devices. Medtronic's shares fell 1.24% in premarket trading following the news.
August 24, 2023 | 12:45 pm
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POSITIVE IMPACT
Otsuka Medical Devices, parent company of Recor Medical, received backing from the FDA for its high blood pressure treatment device.
The FDA's backing of Otsuka's device is a positive development for the company, which could lead to increased revenues and profitability in the future. This news could potentially lead to an increase in the company's share price.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
POSITIVE IMPACT
Otsuka Medical Devices, parent company of Recor Medical, received backing from the FDA for its high blood pressure treatment device.
The FDA's backing of Otsuka's device is a positive development for the company, which could lead to increased revenues and profitability in the future. This news could potentially lead to an increase in the company's share price.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
Medtronic's high blood pressure device failed to gain FDA approval, leading to a drop in the company's share price.
The FDA's decision not to approve Medtronic's device is a significant setback for the company, which could negatively impact its future revenues and profitability. This news has already led to a drop in the company's share price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100