CephX wins FDA clearance
CephX received FDA clearance for a 3D AI imaging product, expanding its ability to integrate advanced imaging into clinical workflows — a tangible regulatory win in a crowded medtech AI field. FDA clearance opens commercial pathways and competitive positioning for hospital sales teams. (x.com)
Orca Dental AI issued the PR Newswire release on March 24, 2026 and included a quote from CEO and founder Daniel Abraham in the announcement. (prnewswire.com) The release names the product CEPHX3D and lists it as a Class II 510(k) device with AI CBCT segmentation for the mandible, maxilla, full dentition (crowns and roots) and the inferior alveolar nerve (IAN). (prnewswire.com) CEPHX3D also includes an interactive web-based 3D STL and DICOM viewer and linear, angular and volumetric measurement tools plus CBCT cross-section reports, according to the company product description. (prnewswire.com) Orca announced expanded integrations with DEXIS’ DTX Studio platform (integration announced February 12, 2026) and with Greyfinch’s cloud-based orthodontic practice management software to enable uploads of 2D cephalometric images or 3D CBCT scans and AI-generated analyses. (dexis.com) The PR release says CephX is already used by thousands of orthodontists and DSOs across more than 180 countries, a footprint also referenced in industry coverage. (prnewswire.com) FDA records show an earlier CEPHX 510(k) on file (K231396), and the company’s materials position the new 3D filing as adding 3D capability to its existing cleared product lineage. (accessdata.fda.gov)
