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Biolinq's Needle-Free Glucose Monitor, Biolinq Shine, Gains FDA Approval

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Heartspace News Desk
Source: Medtech Magazine
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Key takeaways

  • Biolinq received FDA approval on October 1, 2025, for its needle-free continuous glucose monitor (CGM), the Biolinq Shine, representing a significant advancement in glucose monitoring technology
  • Unlike traditional CGMs, which rely on needle-based sensor insertion beneath the skin, the Biolinq Shine utilizes a microneedle array
  • Biolinq asserts that these microneedles are positioned up to 20 times more superficially than conventional sensors, a design intended to enhance user comfort
Biolinq received FDA approval on October 1, 2025, for its needle-free continuous glucose monitor (CGM), the Biolinq Shine, representing a significant advancement in glucose monitoring technology. Unlike traditional CGMs, which rely on needle-based sensor insertion beneath the skin, the Biolinq Shine utilizes a microneedle array. Biolinq asserts that these microneedles are positioned up to 20 times more superficially than conventional sensors, a design intended to enhance user comfort. The Biolinq Shine is a coin-sized, patch-like device worn on the forearm, providing a less invasive and more comfortable glucose monitoring experience.

Related Topics

BiolinqFDA ApprovalGlucose MonitorCGMMicroneedle TechnologyMedical DeviceMedtech

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