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Category: Press Releases

RTsafe, with collaboration from JALEX Medical, gets 510(k) FDA clearance for Personalized PseudoPatient™.

By JALEX Medical
July 31, 2018 Category: Press Releases

For the first time in the US, therapists can safely simulate and verify an individual radiotherapy treatment cycle before exposing the patient suffering from brain cancer to potentially harmful radiation. The PseudoPatient dosimetry phantoms, built from real patient anatomical data, combine proven expertise in medical physics with highly accurate 3D printing technology for radiotherapy treatment. JALEX Medical partnered with the Greek based company in 2017 as their United States based regulatory consultants. RTsafe came to Ohio via the SelectUSA program, which is a division of the United States Chamber of Commerce aimed at bringing medical device companies to the United States. JALEX Medicals president, Jennifer Palinchik, participated as a featured speaker and mentor during the Cleveland event. Its exciting to see the continued advancements that are being made in the medical industry with 3D printing, and the PseudoPatient device is yet another example of brilliant forward thinking

PRESS RELEASE - Omnia Medical: First PEEK-OPTIMA HA Enhanced Vertebral Body Replacement System to enter US-market

By JALEX Medical
December 08, 2017 Category: Press Releases, News

US FDA 510(k) clearance paves the way for an innovative orthopaedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes.1-3 Thornton Cleveleys, United Kingdom, December 7, 2017 Omnia Medical VBR has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK. Robert Gewirtz, MD- Neurosurgeon, Columbus, Ohio, comments on the innovative orthopedic product: Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated

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