South Korea’s Ministry of Food and Drug Safety signed a confidentiality agreement with Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to boost bilateral regulatory cooperation in the field of medical devices.
Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.