The Hainan Medical Products Administration has granted marketing approval to a heart-lung walking test data analysis software following a priority review process. This digital therapy product, classified as a Category II medical device, is designed to assist healthcare professionals in evaluating patients’ exercise cardiopulmonary function, excluding automatic diagnosis. The approval underscores the growing integration of digital health solutions in medical practice.
To date, Hainan province has approved a total of six digital therapies as Category II devices. These approvals are part of a broader trend of embracing digital health innovations, with a total of 10 such products having been filed for marketing through the priority review channel. The priority review process is indicative of the region’s commitment to expedite the availability of innovative medical technologies to patients.- Flcube.com
