Palliare Receives EU CE Mark Approval for New Medical Devices Regulation

Saturday, July 29, 2023

Palliare, a leading developer of advanced insufflation technologies, has achieved a major milestone by obtaining EU CE Mark certification under the new EU Medical Devices Regulation (MDR) for its EVA15 insufflator and smoke evacuation system. This certification makes EVA15 one of the first laparoscopic and endoscopic insufflators to meet the stringent regulatory requirements introduced in 2021 for medical devices in Europe. As a result, Palliare is now authorized to commence shipments to the European market immediately.

CEO John O'Dea expressed his satisfaction with the clearance, emphasizing its importance for the company. Certifying EVA15 as a Class 2b device under the new MDR regulation required a thorough and comprehensive effort. This achievement now positions the company on a strong regulatory approval footing in Europe for the foreseeable future. Palliare has already begun the process of installing EVA15 in leading robotic surgical training centers across Europe.

Additionally, Palliare has established a significant partnership with Northwell Health, the largest healthcare provider in New York. Through their Global Strategic Partnerships team and International Business Program, Northwell Health selected Palliare as a valuable addition to their Group Purchasing Organization (GPO) alliance. This collaboration aims to streamline engagement with international companies that can bring value to Northwell, ranging from procurement to pilot projects and potential investment opportunities.

Elaine Brennan, Executive Director of Global Strategic Partnerships at Northwell Health, expressed her enthusiasm for Palliare joining their GPO alliance and highlighted the program's focus on fostering beneficial relationships with international companies.

David Corcoran, Head of US LifeSciences at Enterprise Ireland, expressed pride in supporting Palliare's expansion journey in the United States. He commended Palliare's innovative smoke evacuation and insufflation technologies for their positive impact on surgical operating rooms and patient safety. Furthermore, he expressed delight in the collaboration between Palliare and Northwell Health, as Northwell Health is a longstanding strategic partner of Enterprise Ireland and a leading US healthcare system.

In summary, Palliare's accomplishment of obtaining EU CE Mark certification and its strategic partnership with Northwell Health signify significant progress for the company in the medical devices sector. With its innovative technologies and growing market presence, Palliare is poised to enhance patient procedures and safety while contributing to advancements in the medical field.

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