iORBIT Achieves FDA 510(k) Clearance for Next-Generation Wearable Patient Monitoring System

2025

iOrbit Digital Technologies has received FDA 510(k) clearance for its next-generation wearable wireless patient monitoring system, built on the company's iTouch platform. The clearance, granted under 510(k) number K243837, confirms that the device - registered with the FDA as "iBSM" - has been reviewed and found substantially equivalent to legally marketed predicate devices, under the Cardiovascular regulation category (21 CFR 870.2910).

The application was submitted in December 2024 and received FDA clearance in May 2025 following a Traditional 510(k) review. Notably, the clearance covers a broad range of physiological monitoring functions, reflected in the multiple product codes associated with the filing - spanning breathing rate monitoring, pulse oximetry (SpO₂), non-invasive blood pressure measurement, continuous temperature monitoring, bed-patient monitoring, and ambulatory ECG.

At its core, the iTouch platform is a compact, patch-based wearable system designed for real-time tracking of key vitals, including ECG, heart rate, respiratory rate, SpO₂, posture, and skin temperature - all seamlessly integrated with bedside monitors and remote monitoring systems. From UX and hardware design to cloud infrastructure, risk management, and regulatory compliance under ISO 13485, iOrbit managed the entire product lifecycle in-house, from concept through FDA clearance.

This milestone reinforces iOrbit's mission to empower healthcare OEMs with certified, market-ready connected health solutions, and marks a significant step in the company's continued growth as a global IoMT platform provider - extending its regulatory footprint from Indian and European markets into the U.S. healthcare system.

📧 sales@iorbit-tech.com

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