FDA approval of BioIntelliSense’s patient monitoring system signals major progress in remote patient monitoring market

In October 2024, BioIntelliSense received approval from the US Food and Drug Administration (FDA) for its BioButton Multi-Patient wearable and BioDashboard system, aimed at enhancing hospital-based virtual care programmes and extending patient monitoring into the home. This development marks a significant step forward in remote patient monitoring (RPM), an area that became critically important during the Covid-19 pandemic, according to GlobalData, a leading analytics and data company. GlobalData forecasts that the RPM market will grow from $548.9m in 2020 to $760m by 2030, with a compound annual growth rate of 3.3% over the period. Major players in the RPM market include Boston Scientific, GE Healthcare, and Medtronic, as reported by GlobalData.

As healthcare systems worldwide grappled with challenges brought on by the Covid-19 pandemic, the need for scalable, continuous patient monitoring became essential, particularly to support care beyond traditional hospital environments. RPM devices are thus poised to become a cornerstone of healthcare for patients around the globe. BioIntelliSense’s innovative solution automates the collection of vital signs and delivers real-time data, meeting the post-pandemic demand for efficient, remote healthcare options that prioritise patient safety and enhance clinical outcomes. By transitioning from episodic to continuous monitoring, the BioButton Multi-Patient wearable and BioDashboard system enables clinicians to detect early changes in a patient’s health, ensuring timely, proactive intervention. This comprehensive approach boosts patient safety, streamlines clinical workflows, and optimises resources by automating vital sign trend monitoring, reducing the need for manual tasks such as spot-checking and documentation. In the rapidly advancing wearable technology market, companies such as Apple, Fitbit, and Garmin have also introduced health-focused devices, incorporating features such as heart rate, blood oxygen, and electrocardiogram monitoring for consumers. However, BioIntelliSense sets itself apart with medical-grade monitoring capabilities specifically designed for clinical settings, bridging the gap between general consumer health tracking and the rigorous demands of clinical monitoring.