Lupin Digital secures Class C medical device license from CDSCO

Mumbai: Lupin Digital Health’s Lyfe, a Digital Therapeutics (DTx) platform, has attained Class C license for manufacturing medical devices from the nodal agency Central Drugs Standard Control Organization (CDSCO). With this it has become the first chronic condition management platform to be recognized under this category.

Elaborating on the significance of development, Sidharth Srinivasan, CEO, Lupin Digital Health said, "Securing the Class C medical device license for Lyfe is a significant achievement. It validates Lyfe as a best-in-class platform to support millions of cardiac patients in India. This recognition will also encourage more cardiologists, hospitals and insurers to adopt remote cardiac rehabilitation for improved patient health outcomes.”

Commenting on the move by the regulatory body, Rajeev Sibal, President , India Region Formulations, Lupin, stated, "This approval reaffirms our dedication to excellence in cardiac care. We are proud to be at the forefront of digital therapeutics in India, signifying our commitment to supporting cardiologists with patient-centric solutions and improving cardiovascular outcomes.",

Lyfe, is a remote cardiac rehabilitation program powered by artificial intelligence (AI) and machine learning (ML), which deals with the treatment of chronic diseases by reducing the risks and costs of hospitalisation.