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

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

RevBio has received the FDA investigational device exemption (IDE) approval to conduct a clinical trial of its cranial flap ...

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

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

More than 3 million Americans with pacemakers depend on these chemicals to live.

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 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 ...

ResMed dominates the global sleep apnea device market, boasting a 50–60% share and a high-margin razor-razor-blade business ...

AI tools in healthcare are no longer just boosting efficiency. They are reshaping how care is delivered, managed, and personalized. Below are the ...