RTsafe Receives 510(k) FDA Clearance for Personalized Radiotherapy Verification Product for Brain Cancer Treatment

18 Jul 2018

New Personalized PseudoPatient™ promises increased patient safety: Radiation dosage and targeting can now be verified on ‘phantom patient’ before live treatment

SAN ANTONIO, Texas - July 18, 2018 - RTsafe (www.rt-safe.com), a medical technology company focused on improving the safety and accuracy of radiotherapy for cancer and other medical conditions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Personalized PseudoPatient™ a patient-specific radiotherapy treatment verification product for patients suffering from brain cancer or brain lesions. RTsafe will showcase Personalized PseudoPatient at the AAPM conference in Nashville, Tennessee, July 29-Aug. 2, at booth #337.

Radiation therapy is commonly used for brain cancer treatment but it is a highly complex process. RTsafe’s Personalized PseudoPatient is the world’s first personalized pre-treatment simulation system for quality assurance in radiation oncology. At the heart of the concept is an anatomically authentic head phantom of individual patients suffering from brain tumors. Using each patient’s anonymized CT scans, and deploying highly accurate medical grade 3D-printing technology and the latest dosimetry methodologies, RTsafe can create a patient-specific phantom which reacts to radiation in the exact same way that human tissue does. RTsafe’s Personalized PseudoPatient is a perfect replica of the real patient’s head and bone structure, both externally and internally. This means that a treatment cycle can be simulated with extreme accuracy before the patient is exposed to radiation.


”RTsafe’s Personalized PseudoPatient is a major step towards increasing the safety and efficiency of radiation therapy by enhancing confidence among both radiation oncologists and cancer patients”, said Evangelos Pappas, CEO and founder of RTsafe. "After the 510(k) FDA clearance, our technology and personalized quality assurance solutions are now available to all US brain cancer patients. Given the critical importance of accuracy in brain radiotherapy, we believe that health professionals and patients alike will welcome the opportunity to simulate and verify treatment in a totally safe environment before irradiating live tissue."

The Personalized PseudoPatient is a pre-treatment end-to-end verification head phantom. It enables radiotherapy professionals to test every radiotherapy procedure on an anatomically perfect facsimile of the patient before the actual treatment is performed. Moreover, it can be deployed as an additional measure to conventional commissioning quality assurance of radiation delivery equipment on real clinical cases. Radiotherapy auditors can also benefit from Personalized PseudoPatient as they have the opportunity to perform an audit to the whole radiotherapy treatment chain. Finally, insurance companies will be reassured in advance that any procedure they are underwriting will be carried out with the highest possible accuracy.

About RTsafe

RTsafe is a medical technology company that has developed a unique approach to quality assurance that significantly enhances the safety and accuracy of radiotherapy for cancer and other medical conditions. It combines proven expertise in medical physics with highly accurate 3D printing technology to create pseudo‐in‐vivo dosimetry phantoms towards End‐to‐End commissioning, benchmarking and patient‐specific quality assurance in SRS, IMRT, VMAT and SBRT applications. The anatomically accurate effigies enable medical professionals to plan more precise treatment interventions for each individual patient and help radiotherapy technology innovators to fine‐tune their products. The result is more effective individualized therapy and reduced patient risk. For more information, visit www.rt-safe.com.

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Press Contacts:
Evangelos Pappas
epappas@rt-safe.com

Tina Miteko
tinamiteko@rt-safe.com