Twiist Automated Insulin Delivery System Cleared by the FDA
DEKA Research and Development Corp has received 510(k) clearance FDA for the twiist Automated Insulin Delivery system powered by Tidepool.
DEKA Research and Development Corp has received 510(k) clearance FDA for the twiist Automated Insulin Delivery system powered by Tidepool.
DermaSensor received FDA clearance for its AI-powered, real-time, non-invasive skin cancer evaluation system.
Siemens Healthineers has received U.S. FDA clearance for the Biograph Vision.X PET/CT scanner, featuring advanced detector technology with small LSO crystals and fast time-of-flight capabilities.
DEKA Research and Development Corp has received 510(k) clearance FDA for the twiist Automated Insulin Delivery system powered by Tidepool.
Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.
Read MoreThe FDA cleared the CorVista System with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.
Read MoreInsight Medbotics has received U.S. FDA 510(k) clearance for its MRI-compatible IGAR robot for breast biopsy indications.
Read MoreLimaca Medical’s Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.
Read MoreThe FDA has cleared Zeta Surgical’s Zeta Cranial Navigation System mixed reality surgical navigation system.
Read MoreAlveofit announces that its respiratory device, Alveoair spirometer, has earned FDA clearance for distribution in the United States.
Read MoreXenex was granted De Novo FDA authorization for the LightStrike+ device, a high-intensity, broad-spectrum UV light robot.