TechMah CMF has received US Food and Drug Administration 510(k) clearance for its new medical device, the tmCMF Solution.
The new device includes personalised product solutions for reconstruction and trauma procedures in the midface and mandible.
It consists of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments, such as anatomical models, dental splints and surgical guides.
Designed using computerised tomography and dental scan patient image data, the surgical instruments are patient-specific devices.
The SRT software is a surgeon-driven digital solution that combines artificial intelligence and patient-focused healthcare to deliver customised preoperative plans and 3D-printed instrumentation to patients and surgeons globally.
The capabilities of the tmCMF Solution can serve as a preoperative tool to assess and simulate surgical treatments.
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The company anticipates that it will transform the field of craniomaxillofacial reconstructive surgery, besides revolutionising the way healthcare professionals tackle maxillofacial and mandibular surgery.
TechMah CMF president and CEO Dr Mohamed Mahfouz said: “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.
“We are committed to advancing healthcare through ingenuity and this approval underscores our dedication to making a tangible difference in patient care.”
TechMah is planning the commercial release of the device in the third quarter of next year.