3.0 mm Surgify Halo™ burr has received FDA clearance in the United States

We are pleased to share that the 3.0 mm Surgify Halo™ burr has received FDA clearance in the United States.

This is an important step in the continued expansion of the Halo platform and supports broader clinical adoption across geographies.

The 3.0 mm option extends the versatility of the Surgify Halo™, allowing surgeons to address a wider range of procedures while maintaining the controlled, safety-focused design that defines our technology.

Following the introduction of the 3.0 mm size in Europe earlier this year, we have seen strong interest from surgeons and partners. Feedback has underscored the value of expanding the portfolio to meet procedural needs without compromising precision or control.

The development of the 3.0 mm burr reflects focused work across engineering, validation, quality, and regulatory, together with close collaboration with clinicians to ensure performance and reliability in demanding surgical settings.

Thank you to everyone involved.

We appreciate the continued engagement of the surgical community and look forward to continuing the work together in procedures where precision and control matter.

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