In July 2023, Nissha Medical Technologies (NMT) achieved a significant milestone: Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its HeartSync line of disposable defibrillation electrodes. This marked the culmination of years of collaborative efforts across teams within NMT and external partners, solidifying the company’s reputation as a leading global manufacturer of disposable medical electrodes.
A Foundation of Excellence
The journey of HeartSync began with the development of a high-quality defibrillation electrode by the HeartSync company, recognized for its safety, efficacy, and cost-effectiveness. NMT identified the potential of HeartSync’s products early on, leading to its acquisition in May 2019. This integration complemented NMT’s core expertise in disposable, wearable medical technologies and positioned HeartSync as a key brand within the company’s portfolio.
Expanding Market Presence
Prior to PMA approval, HeartSync products, already 510(k)-cleared, were widely utilized across the U.S. healthcare system and had a growing presence in Canada and Europe. Competing in a crowded market of defibrillation electrode manufacturers, HeartSync quickly gained recognition for its reliability and clinical value.
In 2022, the FDA enforced a new requirement for PMA approval of automated external defibrillators (AEDs) and their accessories, reflecting their classification as high-risk devices. HeartSync was positioned to meet this challenge.
Understanding 510(k) vs. PMA
To contextualize, FDA 510(k) clearance applies to devices with moderate risk, while PMA approval is reserved for high-risk products requiring more stringent evaluation. Given the critical role of AEDs in delivering up to 360 joules of electricity during life-saving procedures, the associated defibrillation pads must meet rigorous standards to ensure precise and safe energy delivery.
Meeting the Challenge: PMA Evaluation
NMT’s engineering and development teams had been preparing for the PMA process well before the FDA’s up-classification deadline. Extensive testing and validation efforts were conducted to meet the FDA’s stringent criteria.
Through meticulous preparation and rigorous testing, NMT provided robust data that satisfied FDA requirements, culminating in the successful PMA approval.
Updates to Defib Packaging Post-PMA Approval
Since receiving PMA approval, our defib packaging has undergone several updates. It now specifies use for adults only, replacing the previous adult/child designation. The packaging features the UKCA marking and has been streamlined to include a single barcode. Most importantly, it now lists PMA-approved compatibility. For a complete list of compatible devices, refer to the IFU page.
Building on Success
Now, almost two years into PMA approval, HeartSync continues to deliver value to healthcare systems worldwide, with over 20 million electrodes adopted by hospitals globally. This success story is far from over—NMT remains committed to driving innovation and maintaining the highest standards of quality as the HeartSync brand evolves to meet the needs of the healthcare community