GT Medical Technologies Earns ISO and MDSAP Certifications

TEMPE, Ariz., June 29, 2022 /PRNewswire/ -- GT Medical Technologies announced today that it has earned the International Organization for Standardization (ISO) 13485:2016 certification from GMED. The certification demonstrates the company's compliance with medical device quality management system requirements under the Medical Device Single Audit Program (MDSAP).

ISO/MDSAP certifications emphasize a key achievement in the global commercial expansion plans for GT Medical Technologies' FDA-cleared GammaTile® Therapy.

GammaTile Therapy is Surgically Targeted Radiation Therapy (STaRT) for operable brain tumors, including high-grade gliomas, brain metastases, and malignant meningiomas. Implanted during the last five minutes of brain tumor removal surgery, the GammaTiles start working immediately to eliminate residual tumor cells.

"Achieving ISO and MDSAP certifications is the first step in the process of qualifying GammaTile Therapy for patients with brain tumors outside of the United States and around the globe," said GT Medical Technologies President and CEO Matthew E. Likens. "This demonstrates our ongoing commitment to maintaining the highest standards of quality management to ensure the safety and efficacy of GammaTile."

GammaTile Therapy is currently available to patients at top brain tumor centers across the United States.

Driven to overcome the limitations of current treatments for brain tumors and raise the standard of care, a team of brain tumor specialists joined forces and formed GT Medical Technologies to improve the lives of patients with brain tumors. GammaTile Therapy received FDA 510(k) regulatory clearance for the treatment of all types of recurrent brain tumors and newly diagnosed malignant tumors. The 3D, resorbable collagen tiles embedded with radiation sources are implanted during the last five minutes of brain tumor resection, providing an immediate, dose-intense treatment to eliminate residual tumor cells. This "one and done" procedure allows patients to receive their course of radiation while going about their daily lives, requiring no additional trips to the hospital or clinic for radiation therapy. For more information, visit www.gtmedtech.com and follow @GammaTile on Twitter and LinkedIn.

Media contact:

Lori Kagan[email protected]

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SOURCE GT Medical Technologies