AccuPlan System contains an FDA-approved suite of technologies, tools and software used to design and produce patient-specific medical devices
MedCAD receives FDA approval for AccuPlan System. (Credit: vipra gen from Pixabay.)
MedCAD is proud to announce 510(k) market clearance for its new AccuPlan® System through the Food and Drug Administration (FDA).
The AccuPlan® System contains an FDA-approved suite of technologies, tools and software used to design and produce patient-specific medical devices. The System helps surgeons leverage the power of computer-aided design to plan for even the most complex surgical procedures with the help of MedCAD’s biomedical design team, cutting-edge 3D printing and manufacturing, and software integration expertise.
“Our custom surgical solutions help surgeons do their best work, and we’re honored to enhance our concierge-level services with a 510(k) clearance for our comprehensive AccuPlan System,” said Nancy Hairston, President & CEO of MedCAD. “We pride ourselves on having second-to-none customer service, so continued investment in our service-related products re-affirms our commitment to satisfying our customers.”
Hairston continues, “Our vision is to customize every surgery with patient-specific and surgeon-specific medical devices, and we’re excited to have the AccuPlan System as the next step in that direction.”
MedCAD has customized thousands of patient-specific medical devices for neurosurgery, oral and maxillofacial surgery, ENT and plastic surgery. Now, with the receipt of the AccuPlan® System 510(k), MedCAD is able to expand into more application types with advanced surgical planning services, products and materials.
“This approval from the FDA represents years of building a strong foundation for a visionary medical device company,” said Brian Buss, Executive Vice President of MedCAD. “The AccuPlan System lays expansive groundwork for exciting new ventures, so we’re looking well beyond AccuPlan to our next several strategic product launches. We’ve had great partners and support through our surgeons and clinical teams, and we’re eager to see our vision of ‘Every Case Custom’ come to fruition.”
Source: Company Press Release