Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
A new draft guidance from the US Food and Drug Administration sets performance criteria for magnetic resonance (MR) coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
The pathway allows specific device types that the FDA believes have an established safety profile to be cleared based on...
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
