San Francisco, California, U.S., November 11, 2026
Skribe Medical has announced significant progress in developing its Aurora wearable cardiac monitoring system following its selection for the U.S. Food and Drug Administration’s (FDA) READI-Home Innovation Challenge. The U.S.-based medical technology company is developing an artificial intelligence-powered wearable solution designed to help healthcare professionals monitor cardiac function in cancer patients receiving treatments that may damage the heart. The company also reported that more than 800 patients have enrolled in its ongoing NOECHO clinical study, conducted across 10 clinical sites in the United States and an additional site in Southeast Asia. The technology aims to simplify cardiac assessments by providing a convenient alternative approach to monitoring heart function during oncology appointments, with the longer-term objective of supporting home-based monitoring. This development is particularly important for cardio-oncology, an expanding area of healthcare focused on identifying and managing cardiovascular complications associated with cancer treatments. The announcement highlights the growing role of wearable medical devices, artificial intelligence and remote patient monitoring in improving the integration of cardiovascular care into cancer treatment programmes.
FDA READI-Home Selection Advances Aurora Development
The selection of Skribe Medical’s Aurora System for the FDA READI-Home Innovation Challenge represents an important milestone in the company’s medical device development programme. The initiative, known as Reducing Readmissions through Device Innovation for the Home, is designed to support innovative medical technologies intended to improve healthcare delivery outside traditional hospital settings. Through participation, selected companies can engage with the FDA and receive early feedback on device development considerations, including technologies intended for home use. This interaction can help medical technology developers better understand regulatory expectations and identify important evidence requirements as they advance their products. Aurora is designed as a wearable, multi-sensor adhesive patch that combines physiological measurements with AI-based analytical software. The system is intended to estimate left ventricular ejection fraction (LVEF), a critical clinical measurement used to assess how effectively the heart’s main pumping chamber circulates blood with each heartbeat. Importantly, participation in the READI-Home Innovation Challenge does not constitute FDA approval, clearance or marketing authorization. It also does not guarantee the outcome of any future regulatory submission. Nevertheless, the programme provides an opportunity for Skribe to obtain regulatory feedback as it continues developing its cardiac monitoring technology.
Aurora Combines Wearable Sensors and AI Cardiac Analysis
Aurora combines electrocardiography (ECG), phonocardiography (PCG) and seismocardiography (SCG) with artificial intelligence-based analysis to estimate cardiac function. ECG measures the electrical activity of the heart, PCG captures heart sounds, and SCG detects mechanical vibrations associated with cardiac activity. By combining these physiological signals, the system aims to generate information about left ventricular function without relying exclusively on conventional echocardiography appointments. The technology is particularly relevant to cancer patients who may experience Cancer Therapy-Related Cardiac Dysfunction (CTRCD) following exposure to certain cancer treatments. Some chemotherapy agents and targeted cancer therapies can affect the heart muscle, potentially reducing its ability to pump blood effectively. Monitoring cardiac function is therefore an important component of cancer care, particularly for patients receiving treatments associated with cardiovascular risks. Currently, echocardiography is widely used to assess LVEF and identify changes in cardiac performance. However, repeated ultrasound examinations can require additional appointments and create logistical challenges for patients already managing demanding cancer treatment schedules. Skribe aims to develop a point-of-care assessment that can be incorporated into routine oncology visits, potentially helping clinicians obtain cardiac information more conveniently. Its longer-term vision includes enabling patients and caregivers to use wearable monitoring technology in home healthcare environments, with results transmitted to healthcare professionals for interpretation.
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NOECHO Clinical Study Enrolls More Than 800 Patients
The company’s ongoing NOECHO clinical study, which stands for Novel On-body Evaluation of Cardiovascular Health for Oncology, is evaluating the performance of Aurora’s wearable measurements against conventional echocardiography, the current clinical reference standard for assessing cardiac function. According to Skribe, more than 800 patients have enrolled across 10 U.S. clinical sites and one additional site in Southeast Asia. The study is designed to generate clinical evidence supporting the accuracy and reliability of wearable-derived LVEF measurements compared with established imaging-based assessments. The growing clinical study population represents an important step in evaluating the technology across different healthcare settings and patient populations. Generating reliable clinical evidence will be essential to determining whether the wearable system can provide useful cardiac information for routine oncology care. Ryan Neely, Ph.D., Co-founder and Chief Executive Officer of Skribe Medical, emphasized that cancer patients already face demanding treatment journeys and that cardiac monitoring should become easier to incorporate into their care. He highlighted the company’s clinical research and participation in the FDA innovation programme as important steps toward achieving this objective. Skribe is also supported by a US$1.65 million pre-seed funding round led by SeaX Ventures, with participation from GoAhead Ventures and Marin Sonoma Impact Ventures. The funding has supported technology development and clinical research, including collaborations with Southeast Asian hospital partners. The latest announcement highlights the increasing importance of AI-enabled wearable cardiac monitoring in cardio-oncology. If future clinical validation and regulatory evaluation demonstrate reliable performance, Aurora could offer healthcare professionals an additional approach to monitoring patients at risk of cancer therapy-related heart complications. Continued research will determine its potential role in improving cardiac surveillance, supporting clinical decision-making and expanding access to convenient heart monitoring.
Source: Skribe Medical press release
