Inmedix® has announced the introduction of its FDA-cleared CloudHRV™ System in the United States

Precision heart rate variability (HRV) launched first to rheumatologists.

(FreePR.org) -- Inmedix® has announced the introduction of its FDA-cleared CloudHRV™ System in the United States, which will be showcased at the Rheumatology Winter Clinical Symposium (RWCS) in Wailea, Maui, from February 12-15, 2025. The Inmedix, Inc. team revealed the US commercial launch following the US FDA’s clearance of the CloudHRV System on January 17, 2025. This diagnostic tool is designed for heart rate variability (HRV) assessment and can be utilized by clinicians based on their professional judgment.

This groundbreaking system is notable for being the first cloud-based HRV diagnostic approved by the FDA, which calculates HRV from a high-quality five-minute electrocardiogram (ECG) while also integrating the Bayefsky indices to evaluate the autonomic nervous system’s (ANS) parasympathetic and sympathetic activities. This marks a significant advancement in HRV analysis, offering enhanced scalability, precision, and cost-effectiveness.

The autonomic nervous system plays a vital role in regulating a myriad of physiological processes within the human body, influencing aspects such as cardiovascular health, gastrointestinal function, neurological responses, endocrinology, psychological well-being, pain perceptions, sleep cycles, and immune reactions (1).

To achieve accurate medical-grade HRV measurements, a detailed ECG is essential to pinpoint each heartbeat and assess the exact intervals between beats. These ECG-derived heart rate variability readings illustrate how the ANS affects cardiac rhythm in response to breathing patterns. Subsequently, mathematical equations are utilized to derive HRV indices corresponding to sympathetic and parasympathetic activities (2).

“Securing FDA clearance for the Inmedix CloudHRV System marks a significant achievement for us,” stated Andrew J Holman, MD, CEO and Co-founder of Inmedix. “We are thrilled to unveil it during one of the leading rheumatology meetings in the US. The RWCS, now celebrating its 18th year, sets a benchmark in the field for peer-reviewed education and patient-centered rheumatology practice.”

References:

Otto Appenzeller, Guillaume J. Lamotte, Elizabeth A. Coon. Introduction to Basic Aspects of the Autonomic Nervous System (Sixth Edition). Academic Press, 2022.
Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3): 354-81.

About Inmedix, Inc. and Inmedix UK, Ltd.
Located in Seattle, biotechnology and medtech company Inmedix, Inc., along with its subsidiary Inmedix UK, Ltd., is dedicated to conducting top-tier research aimed at developing innovative solutions to address urgent healthcare challenges related to stress modulation influenced by the autonomic nervous system (ANS).

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