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510(k) clearance

Medical Devices & Diagnostics

Can Allevion Medical’s Vantage change spinal stenosis workflows by combining disposable access, illumination, and bone resection tools?

Allevion Medical’s Vantage won FDA 510(k) clearance for lumbar decompression. Read what this may change for spinal stenosis workflow, adoption, and risk.

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Medical Devices & Diagnostics

Abanza gains 510(k) for QuadLock ACL system: But is this a clinical leap or an engineering refinement?

Abanza Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for QuadLock, its novel knotless fixation system for anterior cruciate ligament (ACL) reconstruction. The system, which features a bidirectional tension-adjustable design, reportedly offers over a 500% reduction in cyclic displacement compared to conventional fixation methods such as cortical buttons and interference screws, targeting

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Medical Devices & Diagnostics

What the first use of YorLabs’ ICE device tells us about cardiology imaging disruption

Find out how YorLabs’ FDA-cleared ICE platform could transform electrophysiology access and imaging economics in 2026.

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Medical Devices & Diagnostics

KORU Medical seeks FDA clearance to expand FreedomEDGE into HER2+ breast cancer treatment

KORU Medical’s FDA filing to clear FreedomEDGE for PHESGO delivery could reshape cancer infusion workflows. Find out what it means for oncology care.

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