Spineart and eCential Robotics received FDA 510(k) clearance on August 26, 2026 for Spineart's PERLA TL application to run on eCential's Op.n navigation and robotic-assisted platform, extending a previously navigation-only pairing into robotic-assisted workflows. The clearance covers the PERLA TL Open and MIS pedicle screw systems in both open and minimally invasive spine procedures, the companies said in their joint announcement. The clearance changes what the PERLA app does on the Op.n… [...]
The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinforma [...]
In Q1 2026, VentureBeat's Pulse Research surfaced the “Governance Mirage”: the gap between the governance org charts enterprises had drawn and the control layers they had actually built. Fort [...]
Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially rea [...]
Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated non [...]
Withings announced that its multi-function medical device BeamO has received clearance from the FDA. BeamO contains sensors to perform an electrocardiogram, a stethoscope and a thermometer. The compan [...]