Robotica e IA fisica
L’app PERLA TL di Spineart ottiene l’autorizzazione FDA per la chirurgia spinale robotica
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Spineart e eCential Robotics hanno ricevuto l’autorizzazione FDA 510(k) il 26 agosto 2026 per l’applicazione PERLA TL di Spineart da eseguire sulla piattaforma di navigazione e assistenza robotica Op.n di eCential, estendendo una precedente associazione solo per la navigazione a flussi di lavoro assistiti da robot. L’autorizzazione copre i sistemi di viti peduncolari PERLA TL Open e MIS sia per procedure spinali aperte sia per procedure minimamente invasive, hanno dichiarato le due aziende nel loro comunicato congiunto.
L’autorizzazione modifica ciò che l’app PERLA fa sulla piattaforma Op.n. I due sistemi erano già compatibili per la navigazione, con la piattaforma che traccia strumenti e impianti rispetto alle immagini del paziente mentre le mani del chirurgo eseguono il lavoro. La nuova autorizzazione estende l’app a flussi di lavoro assistiti da robot, in cui il braccio robotico della piattaforma guida l’esecuzione del piano chirurgico. Le aziende descrivono il flusso di lavoro combinato come l’integrazione di tecnologia di impianto, navigazione in tempo reale e assistenza robotica in un’unica configurazione, mirata a migliorare la precisione del posizionamento degli impianti e l’efficienza operativa.
“Si tratta di una pietra miliare entusiasmante per la nostra gamma PERLA e per il nostro impegno nell’innovazione della chirurgia spinale. Insieme a eCential Robotics, stiamo introducendo una piattaforma robotica davvero collaborativa che unisce semplicità, precisione e capacità robotiche attive per ridefinire l’esperienza chirurgica per i neurochirurghi e i loro pazienti”, ha dichiarato Laurent Nodé-Langlois, Chief Technology Officer di Spineart, nell’annuncio.
Lisa Jacobs, President of North America at eCential Robotics, framed the clearance as the product of a longer partnership: “Spineart has been a trusted partner and one of the first to believe in our vision for an open robotic platform. Together, we have created a seamless workflow that combines Spineart’s implant expertise with eCential’s navigation and robotics technology.”
A Partnership That Has Been Building Since 2022
The two companies have been working toward this point for nearly four years. Spineart and eCential Robotics announced their partnership in dicembre 2022, agreeing to co-develop spine surgery applications and co-market eCential’s open robotic surgery platform. That was months after eCential’s platform first received FDA clearance for spine surgery in settembre 2022. A second 510(k) followed in luglio 2024 for the platform’s spine navigation and robotic-assistance device, and the world’s first surgeries using the open robotic platform for spine were completed that same month, according to eCential’s news archive.
The platform’s next generation, Op.n GEN 1, received its own FDA 510(k) clearance in marzo 2025. The app ecosystem around it has grown in parallel: ChoiceSpine launched its own application for surgical use on the Op.n platform in giugno 2025, with eCential noting at the time that the ChoiceSpine app followed Spineart’s PERLA app. Nexxt Spine joined the ecosystem as a strategic partner in gennaio 2026, and in febbraio 2026 partner Amplitude Surgical performed its first robotic knee surgeries in Europe using its Andy robot, powered by eCential technology. The PERLA TL clearance fits Spineart’s stated strategy of building what it calls a comprehensive enabling technologies ecosystem around its implant portfolio.
How the Op.n Platform Works
eCential Robotics designs its platform as an all-in-one surgical system combining 2D/3D imaging, real-time navigation, and robotics for bone surgery. The company’s model is deliberately open: rather than locking the robot to one manufacturer’s implants, it hosts third-party applications, so implant companies like Spineart build apps that run on the shared platform. eCential reports more than 100 registered patents, more than 2,500 surgeries performed with its technology, and over 15 clinical and business partners. It operates from dual headquarters in Grenoble, France and Franklin, Tennessee.
The spine-robotics field has been active on the regulatory front elsewhere this summer. Momentis Surgical’s Anovo system gained FDA clearance for multiport surgery in luglio 2026, and Sentante’s endovascular robot entered commercial use in vascular surgery this month. The PERLA TL clearance adds robotic spine surgery to that run, and does so through the app-model route: the implant company’s software, the platform company’s robot, one regulated workflow.
Starting 26 agosto 2026, the PERLA app is on display at the Spineart Innovation Center in Dallas, Texas, alongside the rest of Spineart’s spine portfolio, with demos available by appointment.
