Signal
12 articles covering "medical-devices"
J&J's table-integrated OTTAVA robot completed all 30 gastric bypass procedures without conversion and met safety endpoints, advancing its FDA De Novo application.
A new joint program from FDA and CMS would issue a proposed Medicare coverage decision the same day a breakthrough device wins FDA authorization, aiming to cut total time-to-coverage from roughly a year or more to about two months.
After FDA 510(k) clearance in December and a 45,000-patient global milestone in March, the Cambridge-based surgical robotics company begins placing its modular, lower-cost Versius Plus system in US hospitals.
Real-world data from the first year-long implantable CGM arrives as over-the-counter glucose biosensors pivot toward AI-driven wellness coaching, splitting the market between clinical precision and consumer accessibility.
Epia Neuro emerged from stealth on April 2 with a read/write BCI platform that decodes neural intent and drives a grip-assist prosthetic, targeting first-in-human trials at Lenox Hill Hospital later this year.
Neuralink's VOICE trial decoded silent neural signals from an ALS patient's brain into synthesized speech as the company's BCI program scales to 21 participants worldwide.
Three participants in the Acclaim cochlear implant trial have completed their primary 12-month evaluations, bringing the first fully implanted cochlear implant closer to FDA submission.
The FDA has cleared Butterfly Network's Gestational Age Tool, the first blind-sweep ultrasound AI authorized for U.S. marketing, letting any healthcare worker estimate fetal age in under two minutes.
The FDA granted Breakthrough Device Designation to Nia Therapeutics' 60-channel Smart Neurostimulation System, a closed-loop brain implant that uses machine learning to detect impaired memory encoding and deliver targeted stimulation, marking the first such designation for TBI-related memory loss.
A brain-computer interface developed by Mass General Brigham and Brown University decoded intended finger movements into QWERTY keystrokes at 110 characters per minute with a 1.6 percent word error rate, offering a faster alternative to eye-gaze systems for people with ALS and spinal cord injuries.
Insulet has initiated a voluntary recall of certain Omnipod 5 insulin pump pods after a manufacturing defect caused insulin to leak inside the device rather than reaching patients, leading to 18 serious adverse events including hospitalizations for diabetic ketoacidosis.
China's NMPA approves the world's first commercial brain implant while a BrainGate study demonstrates 110-character-per-minute typing, marking a pivotal week for neural interface technology.