Regulatory Approvals

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avicenna.AI’s CINA-CSpine tool. This AI solution is developed to automatically detect and prioritise...

Alesi Surgical has received FDA 510(k) clearance of its Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing surgical smoke....

Forest Devices received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis. This marks the first FDA clearance for the...

Swiss spine technology company Neo Medical has raised $68m in a Series B funding round to expand its portfolio of surgical technologies across the...

Israel-based health solutions provider Epitomee Medical has received the US Food and Drug Administration (FDA) approval for its advanced ingestible medical device, Epitomee Capsule. Encased...

Argon Medical Devices has launched its CLEANER Vac thrombectomy system, which removes blood clots from the peripheral venous vasculature. The disposable, large-bore aspiration system was...

Penumbra has received a CE mark for its latest computer-assisted vacuum thrombectomy (CAVT) technologies in Europe. These products, Lightning Flash 2.0 and Lightning Bolt 7,...

Matia Mobility has received the Centers for Medicare & Medicaid Services’ (CMS) Healthcare Common Procedure Coding System (HCPCS) code for the Tek Robotic Mobilisation...

SamanTree Medical received FDA 510(k) clearance for its Histolog scanner for tissue imaging. Histolog enables imaging of the internal microstructure of tissues. That includes...