TechMah CMF LLC Receives FDA 510(k) Approval for New tmCMF Solution
[Knoxville, Tenn., Oct. 10] – TechMah CMF LLC, an innovative medical device company, is pleased to announce the FDA 510(k) approval of its cutting-edge medical device, the tmCMF Solution. This approval marks a significant milestone for the company, reaffirming its dedication to advancing healthcare through advanced technology.
The tmCMF Solution is a collection of personalized product solutions for trauma and reconstruction procedures in the mandible and midface. The solution is comprised of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments, including surgical guides, anatomical models and dental splints. The surgical instruments are patient-specific devices and are designed using CT and dental scan patient image data. The SRT software is an intuitive, surgeon-driven digital solution that unites patient-focused healthcare and artificial intelligence to deliver customized preoperative plans and 3D-printed instrumentation to global surgeons and patients.
“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,” said Dr. Mohamed Mahfouz, president and CEO of TechMah CMF and professor of biomedical engineering at The University of Tennessee, Knoxville. “We are committed to advancing healthcare through ingenuity, and this approval underscores our dedication to making a tangible difference in patient care.”
The tmCMF Solution will transform how healthcare professionals approach maxillofacial and mandibular surgery. Its advanced capabilities can serve as a preoperative tool for simulating and evaluating surgical treatments, providing surgeons with greater precision and confidence in their procedures.
With commercial release anticipated in Q3 2024, the tmCMF Solution promises to provide medical professionals with the options they need to deliver higher-quality care and improve patient outcomes.
TechMah CMF LLC was founded in 2021 by Dr. Mahfouz, Dr. Emam E. Abdel Fatah and Dr. Gary To, all industry leaders in biomedical research. The founders were instrumental in the development of the surgical tmCMF Solution.
Looking ahead, TechMah CMF remains devoted to advancing healthcare through inventive solutions. It expects that the tmCMF Solution will reshape the landscape of craniomaxillofacial reconstructive surgery, setting new standards for the best outcomes in patient care. For more information, visit tmCMF.com/technology.
About TechMah CMF LLC
The founders of TechMah CMF LLC—Dr. Mohamed Mahfouz, Dr. Emam ElHak Abdel Fatah and Dr. Gary To—came together to offer advanced craniomaxillofacial (CMF) solutions that address critical market needs. With years of experience in both academia and industry, the team shares a common vision of creating top-quality technology platforms that meet efficiency, effectiveness and sustainability regulations. Their aim is to provide innovative solutions for personalized craniomaxillofacial surgeries that improve patient outcomes and empower surgeons to provide high-quality, effective care.
