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Royal Phillips Receives FDA Clearance For Reusable SpO₂ Clip Sensor
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In desaturation studies, the reusable clip sensor achieved an Accuracy Root Mean Square (ARMS) value of 1.6%, which is nearly twice as accurate as the 3% level recommended by ISO and recognized by the FDA [1]. The sensor also demonstrated consistent performance across a broad range of skin tones, with accuracy varying by less than 0.5% between the light and dark skin pigmentation groups evaluated within an SaO₂ range of 85-100% [1]. These results reflect Philips' rigorous approach to sensor development and validation, with the company's SpO₂ sensor portfolio consistently meeting applicable regulatory performance expectations.

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