Regulatory Approvals

Matia Mobility’s Tek RMD receives HCPCS code

Matia Mobility has received the Centers for Medicare & Medicaid Services’ (CMS) Healthcare Common Procedure Coding System (HCPCS) code for the Tek Robotic Mobilisation...

FDA clears tissue scanner from SamanTree Medical

SamanTree Medical received FDA 510(k) clearance for its Histolog scanner for tissue imaging. Histolog enables imaging of the internal microstructure of tissues. That includes...

Hinge Health unveils new FDA-cleared wireless pain relief device

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...

Turing Medical secures 510(k) clearance automated brain scan system

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...

Germitec gains FDA approval for Chronos ultrasound probe disinfection device

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 Obtains FDA clearance for new Pain Management Device

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 announces MHRA approval for Carevix device

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

FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system

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

Femasys secures CE mark certification for FemVue MINI solution

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...
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