Regulatory Approvals

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...

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance from the U.S. Food and...

The smartphone-sized device offers continuous monitoring of respiration rate while allowing patient mobility. GE HealthCare announced its smartphone-sized Portrait Mobile wireless monitoring solution has received FDA...