Archive

SOMNUM (SOMNUM) — Honeynaps Co., Ltd. (FDA K253390)

This AI-enabled neurology device gains US clearance; Indian clinicians should watch for local availability to aid neurological assessments.

Neurology · FDA — AI/ML-Enabled Medical Devices · 27 Jun

MeRT System — Wave Neuroscience (FDA K260402)

This clearance may expand access to MeRT for neurologists treating brain disorders, but clinical impact depends on evidence—check if it changes your protocol.

Neurology · FDA — AI/ML-Enabled Medical Devices · 3 Jun

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) — Otto Bock Healthcare Products GmbH (FDA K253256)

For clinicians managing amputees, this cleared myoelectric system offers more intuitive prosthetic control, potentially improving functional outcomes and patient satisfaction in daily use.

Neurology · FDA — AI/ML-Enabled Medical Devices · 22 Apr

Stealth AXiS Cranial clinical application — Medtronic Navigation, Inc. (FDA K253379)

New FDA-cleared navigation software for cranial procedures—check if your centre adopts it to improve intraoperative accuracy and workflow.

Neurology · FDA — AI/ML-Enabled Medical Devices · 26 Mar

Onera SleepMap (SLEEPMAP) — Onera B.V. (FDA K253668)

FDA-cleared AI sleep monitor may offer home-based assessment, potentially reducing need for in-lab polysomnography in select patients.

Neurology · FDA — AI/ML-Enabled Medical Devices · 8 Mar

Mazor X System / Mazor X Stealth Edition — Mazor Robotics Ltd. (FDA K251316)

Spine surgeons can now use this cleared navigation platform to improve screw placement accuracy and reduce revision rates in complex procedures.

Neurology · FDA — AI/ML-Enabled Medical Devices · 11 Sept