Insight Medbotics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its magnetic resonance imaging (MRI)-compatible robot, the IGAR system.
The clearance enables...
The US Food and Drug Administration (FDA) has approved CorVista Health’s non-invasive medical device system with a CAD Add-On option for detecting the presence of...
The U.S. Food and Drug Administration announced Sep 6 that it is hoping to modernize the premarket notification 510(k) program that many radiology devices...
Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration approval for the latest-generation WATCHMAN FLX™ Pro Left Atrial Appendage...
Xenex’s microbial reduction LightStrike+ UV Robot is granted FDA authorisation marking a new classification type for UV medical devices.
Ultraviolet (UV) disinfecting solution provider, Xenex...
BPH Energy’s investee company Cortical Dynamics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Brain Anaesthesia Response Monitor (BARM) system...
Ukraine clears breakthrough SaaMD that enables people to usetheir smartphones as clinical-grade devices that listen for cardiovascular disease at home.
Sparrow BioAcoustics announced it has...
The clinician-driven design of the precision system is the foundation of ICU Medical's long-term IV systems product road map that seeks to blend ease...
The FDA cleared two AI algorithms to evaluate the success of PVI ablation for complex arrhythmias.
These tools are available on a price-per-use basis.
CathVision announced...
