In a significant milestone for India’s medical technology sector, Vadodara based Mediyant Technologies has secured USFDA 510(k) clearance and a Central Drugs Standard Control Organisation (CDSCO) Class C manufacturing licence for what is being recognized as India’s first indigenously manufactured heart lung machine. The achievement paves the way for commercial production of the advanced cardiac device, reducing the country’s dependence on imported perfusion systems used during open heart surgeries.

The heart lung machine, also known as a cardiopulmonary bypass (CPB) machine, temporarily performs the functions of the heart and lungs during complex cardiac procedures by maintaining blood circulation and oxygenation. Such systems are critical for surgeries including coronary artery bypass grafting (CABG), heart valve replacement and congenital heart defect repairs.

According to the company, the dual regulatory approvals position Mediyant Technologies to manufacture and market the device both in India and internationally. The startup has already secured export orders from the United States, highlighting the global acceptance of the indigenously developed technology and strengthening India’s ambitions of becoming a global hub for high value medical device manufacturing.

Founder Hiren Desai said the achievement is the culmination of nearly 20 years of experience in the cardiac medical equipment industry and reflects the company’s commitment to developing world-class medical technologies in India. The company aims to address the growing demand for advanced cardiac surgical equipment while supporting the country’s vision of self reliance in healthcare technology.

India performs an estimated 2.5–3 lakh cardiac surgeries annually, with demand continuing to rise due to the increasing burden of cardiovascular diseases, which remain the leading cause of death in the country. Despite this growing need, a large proportion of sophisticated cardiac surgical equipment continues to be imported, making indigenous manufacturing strategically important for improving affordability and supply chain resilience.

The development aligns with the Government of India’s ‘Make in India’ and Production Linked Incentive (PLI) Scheme for Medical Devices, which aim to strengthen domestic manufacturing, reduce import dependence and position India as a global medical device manufacturing destination. The Indian medical devices market, currently valued at around USD 15 billion, is projected to exceed USD 50 billion by 2030, driven by increasing healthcare investments and technological innovation.

Healthcare industry experts have welcomed the milestone, noting that local manufacturing of high end cardiac equipment can reduce procurement costs, improve accessibility and accelerate innovation within India’s medtech ecosystem. The commercial production of India’s first USFDA cleared heart lung machine marks a major step toward strengthening the country’s advanced medical device manufacturing capabilities while enhancing its competitiveness in global healthcare technology markets.