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Precision heart rate variability (HRV) launched first to rheumatologists.
NORMANDY PARK, WA, UNITED STATES, February 23, 2025 /EINPresswire.com/ -- Inmedix®, Inc. (“Inmedix”) announced the US commercial launch of its CloudHRV™ System diagnostic to rheumatologists at the Rheumatology Winter Clinical Symposium (RWCS) in Wailea, Maui, February 12-15, 2025. On January 17, 2025, the US FDA cleared the Inmedix CloudHRV System for US commercialization. Its intended use is as a heart rate variability (HRV) diagnostic to be applied in the clinical setting at the clinician’s discretion.
This is the first system cleared by the FDA as a cloud-based, heart rate variability (HRV) diagnostic calculated from a high-fidelity 5-min electrocardiogram (ECG) which also includes Bayefsky indices of parasympathetic and sympathetic activity of the autonomic nervous system (ANS). It represents a milestone in modern HRV assessment with scalability, precision and affordability.
The autonomic nervous system (ANS) is a fundamental component of the brain which both monitors and directs a broad range of human physiologies, from cardiovascular, gastrointestinal, neurology, endocrine, psychiatry, pain, sleep and the immune system (1).
For medical grade HRV, a precision ECG is required to identify each heartbeat and to measure the precise timing between beats. These ECG measurements of heart rate (pulse) variability over time reflect how the ANS influences cardiac rhythm during breathing. Subsequently, mathematical formulae can be applied to render HRV indices of sympathetic and parasympathetic activity (2).
“Achieving FDA clearance of the Inmedix CloudHRV System was a major milestone,” said Inmedix CEO and Co-founder Andrew J Holman MD, “and we were honored to launch it commercially at one of the premier US rheumatology meetings. The annual RWCS, now in its 18th year, continues to be an educational leader in diligent, peer-reviewed and patient-centered rheumatology science and clinical care.”
References
1. Otto Appenzeller, Guillaume J. Lamotte, Elizabeth A. Coon. Introduction to Basic Aspects of the Autonomic Nervous System (Sixth Edition). Academic Press, 2022,
2. 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 its subsidiary, Inmedix UK, Ltd.
Seattle-based biotech/medtech Inmedix, Inc. and its subsidiary Inmedix UK, Ltd., are committed to engaging in world class research to discover innovative solutions for pressing healthcare needs related to the impact of stress modulated within the brain by the autonomic nervous system (ANS).
NOTICE:
This Press Release contains certain forward-looking statements, including without limitation statements regarding Inmedix’s plans for preclinical studies, effectiveness of its research, product capabilities and the market’s demand for its respective products. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Inmedix’s business which could significantly affect expected results, including without limitation, progress of development, clinical testing, regulatory approval, developments in raw material, personnel costs, sales as well as legislative, fiscal, and other regulatory measures. Any forward-looking statements are qualified in their entirety by this cautionary statement, and Inmedix undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release. This is not an offer to sell or an offer to purchase securities.
Andrew Holman
Inmedix Inc.
+1 206-412-5347
email us here
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