Search Tag: FDA
2024 08 May
The Food and Drug Administration (FDA) has made history by granting the Apple Watch approval as a digital health technology device. Specifically, the FDA has endorsed its atrial fibrillation (AFib) feature as a qualified tool in the Medical Device Development Tools (MDDT) programme. This feature aids in detecting irregular heart patterns and has...Read more
2016 05 Jul
The US Food and Drug Administration (FDA) has approved the Absorb GT1 Bioresorbable Vascular System (Abbott Vascular), with the first absorbable stent for coronary artery disease. Nine members of the Circulatory System Devices panel vs 1 voted that it was safe, and 9 to 1 voted that it had an acceptable risk/benefit profile. In addition, all 10...Read more