6 AI-Enabled Wearable Devices for Clinical Trials in 2026

A wearable can generate a continuous stream of raw sensor data — heart rhythm, breathing patterns, movement — far faster than any human could review it. The companies on this list build AI directly into that pipeline, using it to flag arrhythmias, detect respiratory deterioration, or extract digital biomarkers from raw signal in something close to real time, rather than leaving that analysis entirely to a clinician after the fact.

This list looks specifically at clinical trial wearables providers where AI or machine learning is a stated part of how the device works, not just a company using AI language elsewhere in its business. This is an unranked list — the order carries no judgment about quality or fit. We excluded AI-driven health tools that aren't actually worn on the body — phone-camera vital sign monitors, in-cabin vehicle sensing, and contact-free radar systems — since those are a different category of technology from a wearable device.

Empatica

Empatica designs AI-enabled wearables and digital biomarkers on its FDA-cleared Empatica Health Monitoring Platform, built around the EmbracePlus and EmbraceMini wristworn devices that passively monitor more than 200 digital measures spanning activity, sleep, gait, and light exposure. The company launched EmbraceMini in June 2025 — at 12mm thick, the smallest wrist-worn actigraphy device built for clinical research — with US FDA clearance expected in late 2025, and its original Embrace device was the first FDA-cleared smartwatch in neurology to detect epileptic seizures. Founded in 2011 as an MIT spin-off, Empatica is based in Cambridge, Massachusetts, with additional offices in Milan, Italy, and Seoul, South Korea.

AliveCor

AliveCor applies deep learning to cardiological care through its FDA-cleared KardiaMobile devices, which the company describes as the most clinically validated personal ECG solution available. The KardiaMobile 6L provides instant detection of conditions including atrial fibrillation, bradycardia, tachycardia, and several other rhythm abnormalities directly from a personal, portable ECG reading. Founded in 2010, AliveCor is based in Mountain View, California.

iRhythm Technologies

iRhythm's Zio service uses artificial intelligence to enable uninterrupted cardiac arrhythmia monitoring, letting patients wear a single patch-based monitor for up to 14 days rather than the 48 hours typical of conventional Holter monitors. The company states its technology has analyzed data from more than 3 million patients and has been recommended by the UK's NICE, positioning Zio as a way to eliminate the noise and interruptions common in traditional cardiac monitoring. Founded in 2006, iRhythm Technologies is based in San Francisco, California.

Hexoskin

Hexoskin builds AI-driven smart garments — washable smart shirts first introduced in 2013 — that provide continuous, non-invasive physiological monitoring for clinical research, aerospace, defense, and everyday healthcare applications. The company's Astroskin smart garment has been used by space agencies including NASA, ESA, CSA, and JAXA to monitor astronaut vital signs aboard the International Space Station, and its technology supports clinical trials from Phase 1 through later-stage research backed by more than 250 scientific publications. Founded in 2006, Hexoskin is based in Montreal, Quebec, Canada.

Caretaker Medical

Caretaker Medical's VitalStream device uses its Pulse Decomposition Analysis (PDA) method combined with AI algorithms to deliver continuous, non-invasive measurement of multiple hemodynamic parameters with what the company describes as ICU-grade accuracy. The FDA-cleared, clinically validated wireless finger sensor provides continuous pulse pressure waveforms for cardiac diagnostics, validated in clinical studies against invasive arterial lines and catheters. Founded in 2014, Caretaker Medical is based in Charlottesville, Virginia.

Resmetrix Medical

Resmetrix Medical's wearable respiratory monitoring system uses a wireless chest strap or patch, connected to a smartphone app, to continuously track breathing patterns and detect early signs of respiratory deterioration. The system incorporates AI-powered algorithms that assess disease progression and predict exacerbations, aimed at conditions including COVID-19, asthma, COPD, and pneumonia, in home, isolation, or hospital settings. Founded in 2017, Resmetrix Medical is based in Haifa, Israel.

Explore the full wearables landscape

The companies above represent a portion of a much larger field.

Diligent's platform includes over 170 Wearables Vendors, many with Vendor qualification data available on demand. Book a demo to explore Diligent's full vendor discovery database.

This article is intended as an informational overview of vendors operating in this space. Inclusion on this list does not constitute an endorsement, recommendation, or qualification by Diligent.