Inmedix launches CloudHRV nationwide after FDA clearance

Inmedix began commercial deliveries of its FDA-cleared CloudHRV system to clinics in all 50 states on Aug. 5, bringing point-of-care heart rate variability measurement to physicians nationwide. The launch caps 25 years of research and targets diseases where treatment response is often hard to predict.

Why it matters: - CloudHRV gives physicians an in-office way to measure autonomic nervous system activity, which Inmedix says can help guide treatment decisions. - The launch could affect care in autoimmune disease and fibromyalgia, where patients often cycle through therapies without clear signals on what will work. - Inmedix says the platform is now available to clinicians in all 50 states.

What happened: - Inmedix, a Seattle-based medical diagnostics company, announced the nationwide commercial launch of its CloudHRV platform on Aug. 5, 2026. - The company began delivering CloudHRV devices to medical practices across the U.S. after FDA clearance in 2025. - Hundreds of physicians are already on the waitlist. - As of July 2026, a limited number of U.S. physicians had performed more than 1,950 procedures using the system.

The details: - CloudHRV measures autonomic nervous system, or ANS, function by capturing heart rate variability in the clinic. - The system is designed to measure sympathetic and parasympathetic activity, which are the body’s fight-or-flight and rest/recovery responses. - A patient lies down for five minutes with ECG pads on the wrists and ankles. - The device transmits the heartbeat data to the Inmedix cloud for proprietary analysis and returns results to the physician screen in about 10 seconds. - Inmedix says the platform provides objective point-of-care data in the exam room. - The company says the technology is intended to acquire, display and record ECG information to measure HRV. - The measurements are not intended for any specific clinical diagnosis, and physicians determine the clinical significance. - Inmedix says its FDA-cleared system provides 1996 international standard time and frequency domain HRV as well as geometric domain HRV indices non-invasively in five minutes in the clinic setting.

Between the lines: - The launch fills a gap in medicine, where ANS state at rest has long been discussed as a factor in disease severity and treatment response but has lacked a reliable clinical measurement. - Inmedix is trying to turn a research concept into a routine exam-room tool. - The company’s pitch is strongest in specialties where treatment response varies widely and objective markers are limited. - The emphasis on precision measurement also positions CloudHRV as a tool for monitoring therapy, not just diagnosis.

What's next: - Inmedix is expanding commercial delivery as physicians across the country move off the waitlist. - The company will likely lean on its research base, including 15 clinical studies involving nearly 1,500 patients, to support adoption. - Inmedix and its UK subsidiary say they will continue research focused on stress modulated by the autonomic nervous system. - The company was named one of Fitt/Insider’s 2026 top 50 most interesting health and wellness early-stage startups.

The bottom line: - Inmedix is betting that a faster, office-based HRV readout can make the autonomic nervous system a practical vital sign for everyday care. - More information: Andrew J Holman MD