Senphonix has received a Small Business Innovation Research Phase I award from the National Institutes of Health through the National Heart, Lung, and Blood Institute to advance SleeveSense, its investigational wearable platform for continuous, long-term vital-sign monitoring.
The NIH funding will support clinical-environment testing of SleeveSense’s software stack, cloud and database scaling, and cybersecurity work toward SOC 2 Type II readiness. The award is Senphonix’s second federal research grant within several weeks, following a National Science Foundation STTR Phase I award announced in September.
SleeveSense is being developed as an upper-arm wearable that could continuously monitor vital signs for days, weeks, or months across hospital and at-home settings. Senphonix is designing the system to integrate with existing clinical workflows and make patient information available through electronic health records.
The company is targeting a longstanding healthcare workflow issue: vital signs are often collected manually and intermittently. Senphonix said continuous monitoring could reduce nursing workload while giving clinicians more information about changes in patients’ conditions between routine checks.
After discharge, SleeveSense is also intended to continue collecting data while letting patients view their vital signs through a mobile app. Senphonix plans to manage the underlying infrastructure and offer the platform to hospitals through a per-patient pricing model rather than requiring an upfront capital purchase.
The NIH grant complements the NSF award, which supports development of SleeveSense’s wireless hardware and software platform. Senphonix has also received support from Microsoft, the Arizona Commerce Authority through the WearTech Applied Research Center, and the University of Arizona.
In company-sponsored national research, 98% of surveyed nurses (402 respondents) and 94% of surveyed healthcare CFOs (457 respondents) indicated they would support adopting SleeveSense within their organizations. The surveys were administered by MarketWise Advising, whose founder and president Mike Haldane is also Senphonix’s co-founder and co-CEO.
Senphonix expects to begin a clinical study in late 2026 or early 2027 and intends to pursue FDA 510(k) clearance in early to mid-2027 following clinical testing.
SleeveSense remains in development, has not been cleared or approved by the FDA, and is not commercially available. Its proposed accuracy, clinical performance, and potential benefits will require validation through planned testing and regulatory review.
KEY QUOTES:
“The barrier has never really been the sensor; it’s been building something hospitals can actually put to work and doing it with no upfront cost for them to try. We designed SleeveSense to reduce manual workload and fit the way care teams already operate, with a light footprint and the clinical-grade accuracy we are validating in testing. NIH’s support helps us get the software clinically ready as we work toward bringing SleeveSense to market following FDA clearance.”
Mike Haldane, Co-Founder And Co-CEO Of Senphonix
“Two federal research awards in a matter of weeks, on top of private and state support, and clear demand from the nurses and CFOs who would use and buy it, tells us the market sees what we see. That combination of non-dilutive capital and real demand lets us move efficiently toward commercialization and the partnerships that will bring SleeveSense to health systems.”
John Grant, Ph.D., Co-Founder And Co-CEO Of Senphonix
“For years, I watched companies try to make continuous wearable monitoring work in the real world, and every one of them ran into the same practical barriers that keep it out of hospitals. What convinced me about SleeveSense is that this team went after those friction points head-on, setting out to design around every one of them. That is what has been missing.”
Mark Koppel, M.D., Founding Member Of The Senphonix Advisor Team
