RTsafe, with collaboration from JALEX Medical, gets 510(k) FDA clearance for Personalized PseudoPatientâ„¢.

RTsafe, with collaboration from JALEX Medical, gets 510(k) FDA clearance for Personalized PseudoPatientâ„¢.

ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch

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 Medical's president, Jennifer Palinchik, participated as a featured speaker and mentor during the Cleveland event.

“It’s 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 that can improve outcomes for many cancer patients.” Jennifer Palinchik, President of JALEX Medical

Read the full RTsafe press release

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