First chronic condition management platform to be recognized as a Class C ‘Software as a Medical Device’
Mumbai, April 25, 2024: 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.
About Lupin Digital Health
Lupin Digital Health, a subsidiary of Lupin Limited, a leading global pharmaceutical company, is committed to developing advanced digital health solutions to meet patient needs. Their primary offering, Lyfe, is a remote cardiac rehabilitation program powered by artificial intelligence (AI) and machine learning (ML). Lyfe addresses the crucial challenge of managing chronic diseases effectively, reducing the risks and costs of hospitalization. Through Digital Therapeutics, Lyfe offers timely health guidance, empowering individuals to manage their well-being proactively. With its integrated health monitoring devices, easy technological access, and the expertise of top cardiologists, Lyfe delivers a comprehensive cardiac care solution, helping individuals take control of their health and revolutionize patient care. Visit Lyfe(https://lyfe.in/) for more information.
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About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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For further information or queries, please contact –
Priyanka Chavda
Manager – Corporate Communications
Email: priyankachavda@lupin.com