Palliare Announces FDA 510(k) Clearance of New EVA5 Insufflator
[Galway, Ireland – March 24, 2023] Palliare, an emerging company with the vision to become the world technology leader in advanced insufflation, today announced FDA 510(k) clearance for its new EVA5 insufflator which is purposed for traditional diagnostic and third space therapeutic endoscopy procedures. This extends the EVA family of insufflators to cover a wider range of procedures than that offered by the company’s current EVA15 flagship product alone.
Commenting on the clearance, John O’Dea, CEO, said, “EVA5 fills a gap in our current product offerings in the endoscopy suite, since not all suites require the advanced technology offered by EVA15. EVA5 allows Palliare to offer a complementary and more basic solution for diagnostic procedures, while also offering an ultra-low flow mode for third space endoscopy procedures such as peroral endoscopic myotomy (POEM).