PMA Meaning in Medical Devices: HeartSync’s FDA Approval

PMA Meaning in Medical Devices: HeartSync’s FDA Approval

Defibrillator, NMHS, Patient Monitoring, Quality
What is the PMA meaning in medical manufacturing, and why does it matter? PMA stands for Premarket Approval, the FDA’s most rigorous pathway for approving high-risk medical devices. In July 2023, Nissha Medical Technologies (NMT) received PMA approval for its HeartSync line of disposable defibrillation electrodes. This marked a milestone that reflects years of collaboration, testing, and innovation.PMA Meaning vs. 510(k): What's the Difference?To understand the definition of PMA, it helps to compare it to the more familiar 510(k) clearance process.The 510(k) pathway applies to moderate-risk devices. It allows manufacturers to demonstrate that their product is substantially equivalent to one already on the market.PMA approval is required for Class III, or high-risk, devices. Therefore, these products require extensive testing, clinical data, and a full FDA review before they can be…
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Defibrillation Pads: Essential Tools for Saving Lives

Defibrillation Pads: Essential Tools for Saving Lives

Defibrillator, General Health, Patient Monitoring
Sudden cardiac arrest (SCA) is one of the leading causes of death worldwide, claiming millions of lives every year. Quick access to a defibrillator and the right electrodes can dramatically improve outcomes. That’s where HeartSync defibrillation pads come in — providing reliable, fast-acting support when every second counts.What are HeartSync defibrillation pads?HeartSync Defibrillation pads, (or HeartSync Defibrillator Electrodes), are adhesive devices placed on a person's chest during a cardiac emergency. They conduct electric current from an AED or manual defibrillator to the heart, helping to restore a normal rhythm. HeartSync pads are designed for high performance in critical care situations, making them a trusted choice for hospitals, EMS, and athletic programs alike.How do defibrillation pads work?During cardiac arrest, the heart's electrical signals become irregular or stop altogether. When connected to…
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Expanding Horizons: HeartSync Defibrillation Electrodes Now Registered in Mexico

Expanding Horizons: HeartSync Defibrillation Electrodes Now Registered in Mexico

Defibrillator, Patient Monitoring
By Amy JearyNMT is thrilled to share some exciting news, HeartSync Defibrillation Electrodes have officially been registered in Mexico! This is a significant milestone for NMT, and we couldn't be more excited about the opportunities this presents.HeartSync has already made a substantial impact in various markets around the globe, thanks to its unique features and benefits. Now, we're ready to bring these advantages to Mexico, a country with a vibrant healthcare sector that is always seeking innovative solutions.Improved Access to Quality HealthcareWith HeartSync now registered in Mexico, healthcare providers and their patients will have access to one of the most innovative medical devices in the market. Our goal has always been to improve health outcomes worldwide, and this registration brings us one step closer to achieving that.Validation of Quality and…
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Nissha Medical Technologies Announces Mexico Registration Approval of HeartSync Defibrillation Electrodes

Nissha Medical Technologies Announces Mexico Registration Approval of HeartSync Defibrillation Electrodes

Defibrillator, HS-News, Press Releases
March 15, 2024 – Global Headquarters in Buffalo, NY – Nissha Medical Technologies (NMT), a leading innovator in the medical device and healthcare industry, is pleased to announce their HeartSync Defibrillation Electrodes have successfully achieved registration in Mexico. This significant milestone underscores NMT’s commitment to expanding access to quality healthcare solutions worldwide.The HeartSync Defibrillation Electrodes offer several key advantages over traditional defibrillation electrodes currently available on the market including:Extended shelf life of 36 months with 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 leadwire length options up to 60 inches 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…
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HeartSync Defibrillation Electrodes’ Remarkable Journey To FDA Approval

HeartSync Defibrillation Electrodes’ Remarkable Journey To FDA Approval

Defibrillator, Patient Monitoring, Quality
by Jason Obrokta In July of 2023, after much time, effort and expense, Nissha Medical Technologies (NMT) was awarded PMA approval from the Food and Drug Administration (FDA) for its HeartSync line of disposable defibrillation electrodes. This signaled the culmination of successful efforts by many people inside and outside of the organization and further reinforces NMT as a world-renowned manufacturer of disposable electrodes.   The Origins of HeartSync's Success It all started with the foundation of a great product built by the HeartSync company and their design of a safe, effective, and economic defibrillation electrode. Nissha Medical Technologies had seen the growth and success with the products which made them an appealing acquisition for NMT and one that fit well in its core competency in disposable wearable products. The HeartSync…
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How to Select the Right Defibrillation Pad

How to Select the Right Defibrillation Pad

Defibrillator, Patient Monitoring
By Jason ObroktaWhen looking for a defibrillation pad, the decision-making process requires answers to some basic questions. By addressing these few simple asks up-front, the choice of pad type can be dramatically simplified.  Here are the most important things to consider:What defibrillation device will be used?With recent changes to the classification of defibrillation devices and accessories by the FDA, the list of devices suitable for use in the United State has shortened. Even with fewer options available, it is important to know the device manufacturer when ordering. Each manufacturer of defibrillator utilizes a slightly different connector so this is typically the first question which should be addressed. Who is the patient?A patient type will typically fall into one of two categories. Adult or Pediatric. Most defibrillation electrodes are sized for these…
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