21 July 2023
21 July 2023
The launch of the new analyser comes after it received approval from the US FDA.
Following first time approval from Singapore’s HSA of a smart wearable stethoscope the US FDA follows suit granting 510(k) clearance to the AeviceMD device.
While artificial intelligence (AI) in medical devices has regulatory boundaries, its use in a medicine’s life cycle is less clear.
The data from the trial will be used to design and implement the pivotal clinical study in the US and Europe.
Magnus expects the results from the trial in 2027.
The device creates 3D virtual models of the patient's anatomy using their CT imaging and integrates it with real-time ultrasound.
Each week, Medical Device Network journalists select top tweets that summarise the social media buzz in our sector, underpinned by GlobalData’s analytics.
Following a Series F financing round VitalConnect has secured $30m from investors supporting the company’s commercial growth.
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