Philips has received FDA 510(k) clearance for its noninvasive test of liver tissue stiffness.

The FDA cleared Velano Vascular’s second iteration of its needle-free blood draw device, which attaches to the peripheral IV line that most hospital patients…

Biotronik has received FDA approval for a bare-metal stent designed to treat coronary artery disease.

Medtronic has secured FDA clearance to market its OsteoCool RF Ablation System as a palliative treatment for metastatic bone tumors.

In 2015, the Government Accountability Office announced an investigation into power morcellators, bladed, drill-shaped devices used to remove uterine fibroids…

The FDA has issued a warning about two devices used to treat obesity after receiving upward of 40 reports of adverse events.

Baebies has bagged the FDA’s de novo clearance for its newborn screening device that detects lysosomal storage diseases, such as Gaucher, Pompe and Fabry…

The FDA authorized Abbott’s molecular test to screen for Zika virus in whole blood for emergency situations. It was previously cleared for emergency use in…

Regulatory