Because of its high accuracy, laboratory-based polymerase chain reaction (PCR) testing is the gold standard for infectious disease diagnostics. However, PCR technology requires highly trained staff and costly equipment, hindering its availability, especially in low-resource settings. New research suggests a different kind of test could be more streamlined without sacrificing performance

Cysoni-XT is a temporary cardiac pacemaker from Welsh medtech company Ceryx Medical which aims to boost cardiac performance by resynchronisation of the heart and lungs, a natural phenomenon known as Respiratory Sinus Arrythmia (RSA). The system has shown a remarkable ability to boost performance and induce cardiac repair mechanisms in subjects with heart failure.

Asensus Surgical (NYSE:ASXC) announced today that it received FDA 510(k) clearance for an expanded surgical robot indication.

Samsara Vision announced that it completed the first procedure with its SING IMT miniature telescope technology in China.

FREMONT, Calif., July 23, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System (TMINI 1.1) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). 

eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.

Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance for a new functionality for its Ethos therapy system.

The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.