Open-heart surgery has a paradox at its centre: to repair the heart, the surgeon must first stop it. While the heart is still, another machine takes over its work — pumping blood around the body and filling it with oxygen, beat after beat, for hours on end. It is one of the most demanding machines in all of medicine, and for decades India has bought nearly every one of them from abroad.
A company in Vadodara has just changed that. Mediyant Technologies has built the New Century Heart-Lung Machine, and in July 2026 it became India’s first indigenously manufactured heart-lung machine to win clearance from the United States Food and Drug Administration — alongside a Class C manufacturing licence from India’s own regulator, the Central Drugs Standard Control Organisation (CDSCO). The company has already secured export orders from the United States.
The New Century Heart-Lung Machine in an operating theatre. (Official visual: Mediyant Technologies)
The machine that does the heart’s job
A heart-lung machine — a cardiopulmonary bypass system — temporarily performs the functions of the heart and lungs during complex cardiac procedures, keeping blood circulating and oxygenated while the surgeon works on a still, bloodless heart. It is the machine behind coronary artery bypass grafting, heart valve replacements and congenital heart defect repairs.
The New Century is a modular perfusion platform, built around four belt-driven roller pump modules with a touchscreen control monitor that oversees the whole circuit. The company says the system pairs an integrated centrifugal pump head with third-party compatibility, a high-capacity battery backup that keeps each module running independently, and data management that plugs into hospital record systems. Fine dual-speed control with safety lockouts and follow-function safety logic on the touchscreen are designed to keep perfusion steady through every phase of a procedure.
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Twenty years of fixing other people’s machines
The story behind the machine starts with its founder. Hiren Desai, an NRI entrepreneur, spent nearly twenty years servicing imported heart-lung machines in Indian hospitals — opening them up, tracing their faults, keeping them running through long surgical days. He knew these machines from the inside out, including every way they could fail a perfusionist mid-procedure.
That experience is what Mediyant was built on. The company says the New Century’s engineering, design and manufacturing are all carried out in India — this is a machine designed here, not assembled here. It is an ISO 13485 certified company and a CDSCO-approved manufacturer, working from its facility in the Savli industrial estate outside Vadodara, Gujarat.
Cleared in America, built in Vadodara
The double approval is what makes this a milestone rather than just a launch. The USFDA 510(k) clearance means the machine has passed the American regulator’s bar for safety and effectiveness against established devices, and the CDSCO Class C licence — the category for India’s highest-risk medical devices — clears it for manufacture and sale at home. The company’s registration with the US FDA is on the public record, listing the Century console and its cardiopulmonary bypass pumps.
For Indian hospitals, the significance is practical. India performs an estimated 2.5 to 3 lakh cardiac surgeries every year, and cardiovascular disease remains the country’s leading cause of death — yet a large share of the sophisticated equipment in cardiac operating theatres is still imported. A world-class machine built in Vadodara means shorter supply chains, service engineers who speak the same language as the perfusionists using it, and pricing that puts advanced cardiac care within reach of more hospitals. The Indian heart-lung machine market was valued at about $73.1 million in 2023 and is projected to reach $121.4 million by 2030.
Here’s the company’s own film of the Century perfusion system in action:
What comes next
With both approvals in hand, Mediyant is scaling up manufacturing in Vadodara to meet demand at home and abroad, and the export orders already in place point to a machine the world wants to buy from India, not just one India buys for itself. The portfolio is growing alongside it: the company’s HIVA heater-cooler system and the Mini HIVA for ECMO procedures extend the same perfusion engineering into the rest of the cardiac theatre.
India’s medical device market is valued at around $15 billion today and is projected to pass $50 billion by 2030, with the government’s Make in India and Production Linked Incentive schemes pushing high-end manufacturing home. A heart-lung machine that has cleared America’s regulator and is rolling out of a Vadodara factory is exactly the kind of proof point that ambition needed — a machine that quite literally keeps hearts beating, built by the country whose patients depend on it.
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