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FDA grants Investigational Device Exemption to AgNovos’ spine device

The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to AgNovos Healthcare’s latest investigational product, the AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) kit.

This kit is an investigational device for treating stable but painful vertebral compression fractures through a less-invasive procedure. It was formally granted a breakthrough device designation from the FDA.

The IDE for the AGN1 LOEP SV kit will allow a study to be started to analyse the device’s ability to lower pain and support mobility in vertebral compression fracture patients.