Vadodara: For decades, hospitals across India have relied on imported heart-lung machines from countries such as the United States, Germany and Japan for open-heart surgeries. That dependence may soon reduce, with an NRI-led firm preparing to manufacture what it claimed to be India’s first USFDA-cleared the heart-lung machine.The device has also received a Class C medical device manufacturing licence from the Central Drugs Standard Control Organisation (CDSCO).The breakthrough comes from Vadodara-based Mediyant Technologies, founded by Surat-born NRI entrepreneur Hiren Desai, who is currently based in the US. The company recently secured the licence for its New Century heart-lung machine (HLM), a critical device used during cardiac surgeries.Heart-lung machines temporarily take over the functions of the heart and lungs during open-heart procedures, allowing surgeons to operate while maintaining blood circulation and oxygen supply to the body. India performs an estimated 60,000 to one lakh such surgeries annually and currently has 600 to 1,200 heart-lung machines in operation, according to industry estimates.Desai said the milestone was the outcome of nearly two decades of work in the cardiac medical equipment sector.“When we started servicing imported heart-lung machines, the objective was to understand the technology thoroughly and eventually build it in India. Today, that experience has enabled us to manufacture the machine in Vadodara,” he said.The company claimed the device was the first heart-lung machine manufactured in India to receive both USFDA 510(k) clearance and a CDSCO Class C manufacturing licence.“This is not merely an imported product being assembled locally. The engineering, design and manufacturing have been carried out in India, and our aim is to increase localisation further in the coming years,” Desai said.The Indian heart-lung machine market, valued at $73.1 million in 2023, is projected to grow to $121.4 million by 2030. Desai said indigenous manufacturing could reduce dependence on costly imports and improve access to advanced cardiac care, particularly in smaller cities.With regulatory approvals now in place, the company plans to scale up manufacturing from Vadodara and has already secured export orders from the United States.
