SMAIO: FDA 510(k) Clearance for Custom Version of Surgical Planning Software Co-Developed with NuVasive







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(Boursier.com) — SMAIO a French player specializing in complex spinal surgery with a global offer consisting of software, implantable devices and associated services, announces today that it has received 510(k) authorization from the FDA for the personalized version of the surgical planning co-developed with NuVasive.

Obtaining 510(k) clearance from the FDA for this customized version of the surgical planning software represents a key element of the partnership and license agreement signed in the first quarter of 2022 between SMAIO and NuVasive, a leading American group in technological innovations for the spine. This custom surgical planning software is based on SMAIO’s already commercialized “Balance Analyzer 3D” spinal realignment planning technology.

Philippe Roussouly, CEO of SMAIO, said: “This 510(k) clearance represents a major step towards commercializing our joint planning platform and innovative services to NuVasive customers. We are confident that with our technology, surgeons will soon benefit from a state-of-the-art solution to plan and perform spine surgeries, taking into account individual morphological specificities, and thus improve patient outcomes.”

The achievement of this first milestone, in line with the roadmap presented by SMAIO during its IPO in April 2022, triggers the payment of $3M by NuVasive to SMAIO. As part of this partnership, an additional milestone payment will be triggered after the Balance Analyzer 3D is integrated into the NuVasive platform, with additional technical capabilities.


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