Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...

In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...

Abbott received approval from the Food and Drug Administration for its Volt Pulsed Field Ablation System to treat atrial fibrillation. The medical technology company said Monday that it would soon ...

According to a US pivotal study, the device’s sensitivity has been reported at more than 76% on all specimens.

Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve ...

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...

The FDA has approved the first at-home cervical cancer screening device, designed to make women feel more comfortable with the process, and help them stay on top of crucial health care screenings.

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

A revolution in pregnancy monitoring, Israeli company Pulsenmore, a pioneer in home ultrasound technology, has received official approval from the US FDA to market its Pulsenmore ES device, enabling ...