Regulatory Approvals

Hinge Health launched its Enso 3 FDA-cleared wireless device for reducing musculoskeletal pain. San Francisco-based Hinge designed the device to deliver electrical nerve stimulation...

Chicago-based neuromodulation firm Turing Medical has announced that its automated end-to-end brain mapping system designed to prepare clinicians to carry out neuromodulation therapies has...

French medtech Germitec has received de novo clearance from the US Food and Drug Administration (FDA) for Chronos, its high-level disinfection (HLD) device for...

Zynex, a leading medical technology company specialising in non-invasive medical devices for pain management and rehabilitation, announced FDA clearance of its new TensWave device. The...

Aspivix has announced that its Carevix device has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) for use in the United...

Jupiter Endovascular announced the FDA approved an investigational device exemption (IDE) study for its Vertex system. The company can now conduct the SPIRARE II...

Biomedical company Femasys has secured CE mark certification and Health Canada approval for FemVue MINI, a compact solution for assessing fallopian tubes. Designed for in-office...

An autonomous blood drawing device developed by Dutch company Vitestro has become the first machine of its kind to be granted a CE mark...

Renata Medical shared the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the...