We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has cleared the first medical device under the agency’s Safer Technologies Program (STeP) — Endolumik’s fluorescence-guided gastric calibration tube, which uses near infrared light to allow surgeons to see the tube through the gastric wall during gastric and bariatric surgical procedures.
The FDA has granted de novo approval to Neuromod’s Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.
Abbott’s newly FDA-cleared blood test is the first commercially available diagnostic that assesses whether a patient with a mild traumatic brain injury (mTBI) — commonly known as a concussion — needs further evaluation with a computed tomography (CT) scan.