MedTech News
FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program
SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot.
Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
New ultrasound technology may enable better respiratory disease diagnoses
A team of French researchers demonstrated the efficacy of ultrasound technology to detect low-amplitude movements produced by vocalizations at the surface of the chest.
inHEART receives FDA Clearance for advanced AI-Driven Software Module that optimizes the creation of 3D Models of the Heart
Solution uses fully automated AI segmentation to generate inHEART’s digital twin of the heart with greater speed and efficiency
Implantable sensor could lead to timelier Crohn’s treatment
Wireless sensors monitoring inflammation could prevent or limit damage to intestines
Intuitive lands FDA clearance for new da Vinci robot
The soft tissue robotics leader incorporated new features into the system, from tissue sensing feedback to a smaller size and more comfortable console.
Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site
Inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System.
Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.