Medical Devices
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FDA Approves Sanofi's Sarclisa Escena as First Anticancer Drug Delivered via Wearable On-Body Injector
The FDA cleared a subcutaneous, wearable-device formulation of Sanofi's multiple myeloma drug Sarclisa, the first cancer therapy approved for on-body injector delivery.
FDA Clears EchoNext, the First Multicondition AI Tool to Flag Structural Heart Disease From a Standard ECG
The FDA cleared EchoNext, a deep-learning tool that reads a routine 12-lead ECG to flag six forms of hidden structural heart disease, outperforming cardiologists in a Nature study.
Humacyte's Bioengineered Blood Vessel Beats the Standard AV Fistula in Phase 3 Dialysis Trial, Adding 91 Catheter-Free Days for Women
An interim analysis of Humacyte's V012 Phase 3 trial found its acellular tissue engineered vessel gave women on dialysis 220 catheter-free days versus 129 for an AV fistula.
Siemens Healthineers Wins FDA 510(k) Clearance for Six AI-Powered Artis Interventional Imaging Systems With Optiq Deep-Learning Chain
Six Artis interventional imaging platforms with the Optiq AI deep-learning imaging chain cleared by FDA on May 12, six months after RSNA 2025 debut.
CorTec's Brain Interchange Wins FDA Breakthrough Designation and TAP Acceptance, Becoming the First BCI Cleared for Stroke Motor Rehabilitation
CorTec's implantable Brain Interchange system received FDA Breakthrough Device Designation on April 8 and TAP acceptance on April 23, marking the first BCI worldwide designated for stroke motor rehabilitation.
Philips Wins FDA Clearance for Verida, the First Detector-Based Spectral CT With AI Baked Into the Reconstruction Chain
The Dutch medtech giant cleared a 510(k) for a spectral CT that reconstructs 145 images per second using a deep learning engine, bringing always-on spectral imaging to US hospitals for the first time.
FDA Grants Fast-Track Designation to First Bioengineered Liver for Acute Liver Failure After Phase 1 Trial Shows Promise
United Therapeutics' miroliverELAP, an external bioengineered liver built on a decellularized pig scaffold seeded with human cells, receives FDA RMAT designation after all five Phase 1 patients survived treatment.
Hair-Thin Nerve Implants Decode Phantom Leg Movements in Above-Knee Amputees, Opening Path to Neurally Controlled Prosthetics
Ultrathin electrodes in the sciatic nerve and a spiking neural network decoder classify phantom leg movements in above-knee amputees, enabling bidirectional motor control and sensory feedback from one device.
Continuous Glucose Monitors Split Into Two Markets as Year-Long Implants and OTC Wellness Sensors Reshape Diabetes and Consumer Health
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 Launches with a Minimally Invasive Brain-Computer Interface Designed to Restore Hand Function After Stroke
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.
Johns Hopkins Digital Twin Hearts Achieve 100% Arrhythmia-Free Rate in First FDA-Approved Clinical Trial
The TWIN-VT trial used personalized computational heart models to guide ventricular tachycardia ablation, with all 10 patients remaining arrhythmia-free after more than a year.
Envoy Medical Reports First Patients Reaching 12-Month Endpoint in Pivotal Trial of Fully Implanted Cochlear Implant
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.