Lightweight portable system delivers fast, precise, objective data for rapid aid in diagnosis of concussions in ...

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...

The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...

Two weeks after giving the nod to Imricor's novel ablation catheter, the FDA has cleared the company's overriding 'dashboard' ...

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

In December, the FDA granted breakthrough status for an implantable kidney replacement system for patients with end-stage kidney disease, according to a company press release.The Holly device by ...

The SonoMotion platform will be showcased at booth 1508 during the 2026 American Urological Association meeting.

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not operate this way; it is built to evolve.

FDA approvals, trial progress and early commercial momentum put several ASX healthcare companies in a strong position heading ...