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FDA issues 510(k) clearance for Synaptive’s fluorescence module

The US Food and Drug Administration (FDA) has issued 510(k) clearance to Synaptive Medical’s near-infrared (NIR) fluorescence visualisation module, Modus …

Beacon obtains FDA clearance for SleepStageML software

Beacon Biosignals has secured the US Food and Drug Administration’s (FDA) 510(k) clearance for SleepStageML, a machine learning software designed …

GE HealthCare launches PVA urology-based AI software feature

GE HealthCare has announced the launch of Prostate Volume Assist (PVA), an AI software feature aimed at enhancing urological imaging …

Ypsomed agrees for pen needle and BGMs businesses sale to MTD

Swiss medical technology company Ypsomed has signed an agreement to sell its pen needle and blood glucose monitoring systems (BGMs) …

J&J reportedly eyeing Shockwave Medical for takeover

Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of …