First FDA Approved Defibrillator Released in the USA
Physio-Control's latest announcement is going to shape the world of medicine in big ways: as the Technation Development team has uncovered, the company’s HeartSine samaritan PAD 360P (SAM 360P) fully automatic external defibrillator (AED) is the first to receive US FDA Premarket Approval (PMA) under the new regulatory process and is available for sale in the United States.
Gaining FDA Premarket Approval (PMA) is known to be one of the most meticulous regulatory processes, and HeartSine, acquired by Physio-Control in 2015, is the first of it's kind to receive approval for a new AED product under this regulation.
The Physio-Control HeartSine samaritan PAD 360P is able to analyze cardiac rhythm and automatically deliver electric shock to victims of sudden cardiac arrest without the use of a shock button. It's user-friendly visual and audio prompts, such as CPR coaching, verbally guide the rescuer through the CPR process. Regarding exposure to elements such as dust and water, the new Physio-Control HeartSine AEDs have a durability rating of IP56 and are able to endure a wide array of usage locations.
All of Physio-Controls AED's come with interchangeable Pad-Pak cartridges, also PMA approved, allowing for a "rapid replacement mechanism that enables the battery and pads to be replaced easily in seconds." Physio-Control has a custom line of Cadex battery adapters to ensure maximum up-time of critical equipment such as the HeartSine samaritan PAD 360P.