First chronic condition management platform to be recognized as a Class C ‘Software as a Medical Device’

Lupin Digital Health, India’s first evidence-based cardiology Digital Therapeutics (DTx) platform, is proud to announce that its Lyfe platform has received approval as a Class C Medical Device from the Central Drugs Standard Control Organization (CDSCO). This milestone marks a ground breaking advancement in post-discharge integrated care, highlighting the potential of evidence-based digital therapeutics solutions to transform patient care.

Having undergone a rigorous application, review, and on-site audit process, this Class C Medical Device license reaffirms the platform’s effectiveness and emphasizes its commitment to quality, safety, and rigour.

Lyfe is now India’s first clinically proven remote cardiac rehabilitation program, designed to enhance heart health and quality of life. By providing tailored, accessible solutions in the comfort of patients’ homes, Lyfe empowers individuals to confidently manage their heart health.

Commenting about this recognition, 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 fore front of digital therapeutics in India, signifying our commitment to supporting cardiologists with patient-centric solutions and improving cardiovascular outcomes.”

Elaborating on the significance of receiving this license, Sidharth Srinivasan, CEO, Lupin Digital Health added, “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.”

Trusted by over 700 cardiologists and serving patients across 280 districts in India, Lyfe provides cardiovascular patients who have undergone events like Angioplasty, Bypass Surgery and Heart Failure a better way to manage and recover from their condition.