NEWS RELEASE: Nissha Medical Technologies announces FDA PMA approval of its HeartSync defibrillation electrodes
Buffalo, New York, July 11, 2023: Nissha Medical Technologies (NMT) is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for its HeartSync defibrillation electrodes.
The HeartSync defibrillation electrodes offer several key advantages over traditional defibrillation electrodes currently available on the market including:
- Enhanced patient comfort thanks to smaller pad size, which allows easy positioning around the heart and reduces pressure points from larger pads.
- Greater efficiency with lead-wire length options up to 60 in., which provide greater maneuverability and flexibility than standard lengths while maintaining safety standards.
- Energy distribution through the new conductor plate shape featuring a larger surface area per each terminal plate compared to other brands.
- Improved adhesiveness due to the unique advanced hydrogel material used for the gel layer. This ensures maximum adherence to skin to prevent slipping during ECG monitoring and subsequent defibrillation therapy.
This approval further reinforces the reputation of excellence associated with the products that we produce here at Nissha Medical Technologies,” said Peter O’Loughlin, group VP. “We are proud that the HeartSync defibrillation electrodes were PMA approved by the FDA and that we can continue to provide this lifesaving device to hospitals across the United States. HeartSync has a proven track record of clinical success, and this distinction is a clear indicator of that.”
About Nissha Medical Technologies
Nissha Medical Technologies is a direct-to-hospital medical device manufacturer and full-service product design and contract manufacturing partner, leveraging its global footprint and technical expertise to advance in various markets. Areas of specialization include product design and development, technology integration, vertical integration, and contract manufacturing of complex single-use minimally invasive surgical devices, complex clinical-grade wearable devices, and an assortment of clinical accessories.
The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.