EU Grants its Stamp of Approval: Palliare Now Certified Under New Medical Devices Regulation

Palliare, a pioneer in advanced insufflation technology, has achieved a major milestone in its mission to provide superior medical care solutions. The company recently obtained the EU CE Mark certification under the updated EU Medical Devices Regulation (MDR) for their EVA15 insufflator and smoke evacuation system.

This makes Palliare one of the first to meet the stringent new requirements which came into effect in 2021, and allows them to start shipping their products to the European market without delay. This certification contributes to their goal of delivering high-quality, safe, and reliable healthcare solutions.

John and Caroline O’Dea of Palliare were proudly presented with EVA15 Certification certificates by Kevin Mullaney, Director of Certification at the National Standards Authority of Ireland (NSAI). The joyous couple beamed with pride, symbolizing their recognition of hard work and commitment to deliver the highest standards of quality.

John O’Dea, CEO of the company, expressed his enthusiasm regarding the successful certification of EVA15 as a Class 2b device according to the new MDR regulation, noting that it marks an important step forward for the company.

He went on to announce that they have begun installing EVA15 in leading robotic surgical training centers across Europe, confident that the successful clearance puts the company on a strong regulatory approval footing for the years to come.

NSAI CEO Geraldine Larkin remarked that “Certification is a vital keystone for companies in the medical devices industry to foster progress, secure quality and obtain market access. Ireland is a major stronghold of the medical devices industry in Europe and the capacity of the NSAI to bestow accuracy to products destined for the European market is a crucial part of our assistance to Irish firms.”

Palliare is thrilled to announce it has joined forces with Northwell Health as part of their International Business Program! As the largest healthcare provider in New York, Northwell’s Global Strategic Partnerships team saw an opportunity to connect with the international company and make the most of their procurement, pilot and investment opportunities.

“We’re so excited to welcome Palliare into our GPO alliance and provide our members with an excellent resource,” said Elaine Brennan, Executive Director of Global Strategic Partnerships. Experience the ultimate value by becoming part of Northwell and Palliare’s partnership today!

David Corcoran, Head of US LifeSciences at Enterprise Ireland, cheered on Palliare’s groundbreaking smoke evacuation and insufflation technologies as they began their ambitious scaling journey in the US.

Corcoran further celebrated Northwell Health – a long-term strategic partner of Enterprise Ireland, and a major US healthcare system – for aiding Palliare’s US expansion, which promises to upgrade patient procedures while upholding safety standards.

About the EVA15 Insufflator

The Palliare EVA15 Insufflator and Smoke Evacuation System is revolutionizing the operating room environment, delivering world-class insufflation and smoke evacuation performance suited to laparoscopic, endoluminal, endoscopic, and robotic procedures.

Already approved by the US FDA for sale in the USA, and CE marked for Europe, the EVA15 is a true rival to Conmed’s Airseal System, offering ideal performance and unsurpassable safety standards.

About Palliare

Palliare, founded in 2018 as a spinout from Irish gastro-diagnostic company Crospon, has quickly become recognized as an innovator in medical technologies for advanced surgeries, such as laparoscopic, endoluminal, endoscopic, and robotic surgeries.

With a presence in Galway, Ireland, and Oceanside, CA, this former Medtronic (NYSE:MDT) subsidiary strives to improve the level of smoke evacuation and insufflation to ensure optimal procedures with superior patient outcomes.

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