Regulators cleared two devices with broad clinical implications: the FDA approved Medtronic’s Onyx liquid embolic system for middle meningeal artery embolization as an adjunct to surgery for chronic subdural hematoma, based on the EMBOLISE trial; and Flow Neuroscience won 510(k) clearance for a prescription, at‑home tDCS headset to treat major depressive disorder. Medtronic’s clearance adds a device option for neurosurgeons treating a common neurosurgical complication and may change perioperative workflows. Flow’s approval marks the first FDA‑cleared home brain‑stimulation device for depression, expanding non‑pharmacologic outpatient options; clinical documents cite modest benefit and typical device risks such as headache and skin irritation. Hospitals, payers and device partners will assess adoption and reimbursement plans next.