Regulatory Approvals

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...

Inceptiv is claimed to be the only SCS system in Europe that provides both full-body 1.5T and 3T MRI access. Medtronic has secured CE Mark approval for its...

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration...

ArtiFascia integrates two layers of electrospun nanofibres to create biomimetic scaffolds and a non-porous barrier layer. Nurami Medical has received the US Food and Drug...