Sam Brusco, Associate Editor10.10.23
TechMah CMF has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its tmCMF solution.
tmCMF is a collection of personalized products for trauma and reconstruction procedures in the mandible and midface. It’s composed of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments, including surgical guides, anatomical models, and dental splints.
The patient-specific surgical instruments are designed using CT and dental scan patient image data. TechMah said the SRT software unites patient-focused healthcare and artificial intelligence (AI) to create customized, preoperative plans and 3D-printed instrumentation.
"We are excited to announce the successful 510(k) medical device approval for the tmCMF Solution, which we believe will be a transformative advancement, bridging medical imaging and surgical planning," Dr. Mohamed Mahfouz, president and CEO of TechMah CMF and professor of biomedical engineering at The University of Tennessee, Knoxville, told the press. "We are committed to advancing healthcare through ingenuity, and this approval underscores our dedication to making a tangible difference in patient care."
The company said it expects commercial release of tmCMF in Q3 2024, and that its advanced capabilities can be a pre-op tool to simulate and evaluate surgical treatments. The company was founded in 2021 by Dr. Mahfouz, Dr. Emam E. Abdel Fatah and Dr. Gary To.
tmCMF is a collection of personalized products for trauma and reconstruction procedures in the mandible and midface. It’s composed of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments, including surgical guides, anatomical models, and dental splints.
The patient-specific surgical instruments are designed using CT and dental scan patient image data. TechMah said the SRT software unites patient-focused healthcare and artificial intelligence (AI) to create customized, preoperative plans and 3D-printed instrumentation.
"We are excited to announce the successful 510(k) medical device approval for the tmCMF Solution, which we believe will be a transformative advancement, bridging medical imaging and surgical planning," Dr. Mohamed Mahfouz, president and CEO of TechMah CMF and professor of biomedical engineering at The University of Tennessee, Knoxville, told the press. "We are committed to advancing healthcare through ingenuity, and this approval underscores our dedication to making a tangible difference in patient care."
The company said it expects commercial release of tmCMF in Q3 2024, and that its advanced capabilities can be a pre-op tool to simulate and evaluate surgical treatments. The company was founded in 2021 by Dr. Mahfouz, Dr. Emam E. Abdel Fatah and Dr. Gary To.