Palliare announces EU CE mark approval under new Medical Devices Regulation
Additionally…Palliare Signs First US GPO Agreement with Northwell[28 July 2023] – Galway, Ireland and Oceanside, CA. Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices Regulation (MDR) for its EVA15 insufflator and smoke evacuation system. This makes it one of the first laparoscopic and endoscopic insufflators to meet the new more extensive regulatory requirements introduced in 2021 for medical devices in Europe and will now permit the company to commence shipments to the European market with immediate effect.
Commenting on the clearance, John O’Dea, CEO, said “We believe that this is an important step forward for our company. Certifying EVA15 as a Class 2b device to the new MDR regulation has entailed an extensive exercise, one that puts the company on a firm regulatory approval footing in Europe for the coming years. We have now started the process of installing EVA15 in leading robotic surgical training centers in Europe”.
NSAI CEO, Geraldine Larkin, continued “Certification is a key pillar for companies in the medical devices sector to drive innovation, ensure quality, and to gain market accessibility. Ireland is a major hub for the medical devices sector in Europe and the ability of the NSAI to certify products for access to the European market is an important part of our work in supporting Irish business”.
In further news, Palliare is pleased to announce that it has signed a GPO agreement with Northwell Health, New York’s largest healthcare provider. Palliare engaged with Northwell’s Global Strategic Partnerships team and came through their International Business Program, an established program for international companies to work with the Northwell system. Elaine Brennan, Executive Director of Global Strategic Partnerships said, “We created this program to streamline engagement with international companies that add value for Northwell – from procurement to pilots to investment opportunities – and we’re glad to add Palliare as a solution for Northwell and partner within the GPO alliance”.
Commenting, David Corcoran, Head of US LifeSciences, Enterprise Ireland said “Palliare’s innovative smoke evacuation and insufflation technologies are transforming surgical operating rooms, addressing the growing demands of patient procedures while also enhancing safety. Enterprise Ireland proudly supports Palliare’s US scaling journey, and are delighted that Palliare and Northwell Health, a longstanding strategic partner of Enterprise Ireland and leading US healthcare system, have collaborated to accelerate the adoption of these transformative technologies, driving improved patient outcomes.”
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About the EVA15 Insufflator
The EVA15 insufflator and smoke evacuation system is the first product from Palliare, designed to create a safer operating room environment and deliver best-in-class insufflation and smoke evacuation performance to meet the particular demands of laparoscopic, endoluminal, endoscopic, and robotic surgical procedures. EVA15 is currently cleared by the US FDA for sale in the USA, and is now CE marked in Europe and offers similar smoke evacuation and insufflation performance to the Conmed (NYSE: CNMD) Airseal system.
Palliare was founded in 2018 as a spinout from Irish gastro-diagnostic company Crospon, which was acquired by Medtronic (NYSE:MDT) in 2017. Based in Galway, Ireland, and with US headquarters in Oceanside, CA, Palliare is dedicated to advancing the state of the art in smoke evacuation and insufflation technologies for laparoscopic, endoluminal, endoscopic, and robotic surgery. For more information about Palliare, visit www.palliare.com.