We obtained FDA 510(k) clearance earlier in 2021 for Simpleware ScanIP Medical as software for generating output physical files for "diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications." As one of the few software providers to offer this capability, we are continuing to develop our fast, easy-to-use solution for processing medical image data and preparing models for 3D printing.
Clinicians, point-of-care (POC) laboratories, and other medical professionals can quickly and easily create high-quality patient-specific models within the Simpleware interface, which can then be used to plan surgeries, educate patients, and inform diagnostic decisions. Formlabs’ established strengths in 3D printing for point-of-care and other medical uses makes their printers a valuable addition to our current offering in this area.
Kerim Genc, Business Development Manager for Simpleware software, had this to say about the validation:
"We are excited to add Formlabs to our list of validated 3D printer vendors for our FDA 510(k) cleared solutions. The point-of-care 3D printing market is developing quite nicely as more clinicians are seeing the added value of bringing this technology into their clinical practices, whether in-house or via service providers. Formlabs has a very strong user base, and our goal is to help them leverage our software technology to unlock increased efficiency and scalability, with the end goal of improved clinical outcomes."