Medical Device Start-up Partners With JALEX Medical and Achieves FDA Clearance 5 Months Early

We completed our FDA submission during a federal government shut down and still managed to get the clearance ahead of schedule. I’d estimate five months early.” Vikash Goel Cleveland Clinic Innovations, the commercialization arm of Cleveland Clinic, nurtures and spins off breakthrough inventions into stand-alone companies. Vikash Goel is the CTO and founder of one…

Jennifer Palinchick Receives Crains Cleveland 2019 Notable Women in STEM Recognition

https://www.crainscleveland.com/awards/jennifer-palinchik-notable-stem-2019 Jennifer Palinchik President, JALEX Medical, LLC Most recent education: Master of business administration, Ashland University Before Jennifer Palinchik co-founded medical device company JALEX, she performed artificial pancreas and kidney stem-cell research for animal studies and clinical trials. A specialist in the spine industry, Palinchik expanded her knowledge to include neurology, general surgery and 3D printing.…

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

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…

JALEX Medical named key market leader in VBR by Becker’s Spine

Read the full article here: https://www.beckersspine.com/surface-technology/item/45038-5-things-to-know-about-the-vertebral-body-replacement-device-market.html 5 things to know about the vertebral body replacement device market Shayna Korol – Wednesday, March 13th, 2019 Titanium-based vertebral body replacement devices generate more revenue than PEEK-based vertebral body replacement devices, according to a Persistence Market Research report. Five things to know about the global vertebral body replacement device market: 1.…

Omnia Medical with Invibio, Victrex, and JALEX: First PEEK-OPTIMA HA Enhanced Vertebral Body Replacement System to enter US-market

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. 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…