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Epitel’s REMI system and REMI Vigilenz AI receive FDA 510(k) clearance

Epitel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its REMI Remote EEG Monitoring System …

Penumbra secures FDA clearance for Lightning Flash 2.0 thrombectomy system

US-based thrombectomy company Penumbra has secured FDA clearance and launched its Lightning Flash 2.0, a next-generation computer-assisted vacuum thrombectomy (CAVT) …

SAIL Fusion secures FDA clearance for BowTie Sacroiliac Fusion System

SAIL Fusion, a medical device company advancing the surgical treatment of sacroiliac joint dysfunction, has announced clearance from the US …

Neuronoff completes first-in-human trial for Injectrode to treat chronic pain

Neuronoff, a medical device company developing minimally invasive neuromodulation solutions, has announced the completion of a first-in-human clinical trial for …

Pelvital raises $2.3m to advance commercialisation of Flyte device

US-based women’s health medtech company, Pelvital, has closed an additional $2.32m in seed plus funding to commercialise its Flyte device. The …