Indigenous Device Gains Global Approval
India has achieved a significant milestone in cardiac medical technology with the development of a homegrown heart-lung machine by Vadodara-based Mediyant Technologies. The company’s New Century Heart-Lung Machine (HLM) has received USFDA 510(k) clearance and a Class C medical device manufacturing licence from the Central Drugs Standard Control Organisation (CDSCO).
Supporting Open-Heart Surgeries
Heart-lung machines temporarily perform the functions of the heart and lungs during open-heart surgery. They maintain blood circulation and oxygen supply while surgeons operate on the heart.
According to The Times of India, India performs an estimated 60,000–100,000 open-heart surgeries annually and currently has around 600–1,200 heart-lung machines in use.
Reducing Dependence on Imports
Mediyant Technologies, founded by NRI entrepreneur Hiren Desai, developed the device after nearly two decades of experience servicing imported heart-lung machines. Unlike products that are merely assembled locally, the company says the device’s engineering, design and manufacturing are carried out in India.
Moreover, indigenous production could reduce dependence on expensive imported equipment and improve access to advanced cardiac care, particularly in smaller cities.
Manufacturing and Exports to Expand
The Indian heart-lung machine market was valued at approximately $73.1 million in 2023 and is projected to reach $121.4 million by 2030. With regulatory approvals now in place, Mediyant Technologies plans to scale up manufacturing in Vadodara and has already secured export orders from the United States.