India has taken a major step towards strengthening domestic cardiac medical-device manufacturing with the development of an indigenous heart-lung machine by Vadodara-based Mediyant Technologies. The company’s New Century Heart-Lung Machine (HLM) has secured USFDA 510(k) clearance along with a Class C manufacturing licence from the Central Drugs Standard Control Organisation (CDSCO), paving the way for wider domestic use and international expansion.
Supporting Critical Cardiac Procedures
A heart-lung machine is a vital piece of equipment used during open-heart surgeries. It temporarily takes over the functions of the heart and lungs by maintaining blood circulation and oxygenation while surgeons operate on the heart.
India conducts an estimated 60,000-100,000 open-heart surgeries every year, with approximately 600-1,200 heart-lung machines currently in use across healthcare facilities.
Built and Manufactured in India
Mediyant Technologies was founded by NRI entrepreneur Hiren Desai and developed the New Century HLM drawing on nearly two decades of experience in servicing imported heart-lung machines.
The company says the machine is not simply assembled in India. Its engineering, design and manufacturing have been undertaken domestically, marking a move towards greater self-reliance in sophisticated cardiac equipment.
Potential to Cut Import Dependence
The indigenous machine could help reduce hospitals’ dependence on costly imported heart-lung systems and potentially make advanced cardiac technology more accessible.
Greater availability of locally manufactured equipment could be particularly beneficial for hospitals in smaller cities and emerging healthcare markets, where access to advanced cardiac infrastructure remains limited.
Vadodara Manufacturing to Scale Up
With regulatory clearances in place, Mediyant Technologies is preparing to expand production at its Vadodara facility. The company has also received export orders from the United States, creating an opportunity for an Indian-designed cardiac medical device to enter international markets.
The Indian heart-lung machine market was valued at around $73.1 million in 2023 and is projected to reach approximately $121.4 million by 2030, indicating significant growth potential for indigenous manufacturers.
