Medable, Inc.

Remote patient monitoring company, Withings Health Solutions, a division of Withings, announced the release of BPM Pro 2, a cellular blood pressure monitor. The blood pressure monitor includes a Patient Insights feature that aims to simplify clinical workflows by collecting critical data via the device, including symptoms and medication adherence. Additionally, care teams have the capability to send patients customized messages and reminders. Data is immediately synced through cellular connectivity that allows healthcare partners to access the patient-generated data via their personal clinical platform or Withings proprietary patient-monitoring platform. It also offers WiFi and Bluetooth connectivity options. In addition to measuring heart rate and blood pressure, BPM Pro 2 is intended to have a future ability to take a 1-lead ECG to detect atrial fibrillation. According to the company, the portable device is compact and user-friendly. It supports two cuff sizes (9 to 17 inches and 16 to 21 inches), and displays blood pressure readings and other information in bold text, and in color. The device also includes a symptom-tracking feature whereby patients are asked customized questions to capture information like symptoms, medication adherence and sleep patterns. It can be structured to automatically cue patients to retake their blood pressure if it reaches a specific predetermined threshold. The device will be available in November, when the company expects FDA clearance. "At-home blood pressure monitoring has become a standard across the industry for managing chronic conditions like hypertension and heart failure but poses a real challenge in making sure the data collected is consistent, reliable, and actionable for care teams," Aline Criton, chief clinical and regulatory affairs officer at Withings, said in a statement. "Elevated readings may result from simple factors like improper rest before a measurement or signal more serious issues such as the start of a hypertensive crisis. BPM Pro 2 addresses these challenges with advanced features that enhance data reliability, and provide contextual patient insights that help care teams differentiate between routine variations and critical health events allowing for more timely and personalized care intervention." THE LARGER TREND In September, Withings secured FDA clearance with Sleep Rx Mat, a contactless device designed to diagnose sleep apnea at home. Sleep Rx Mat provides detailed analysis of sleep, breathing and cardiovascular activity all through the night. Last year, the company launched U-Scan, a biomarker assessment platform that can be put inside a toilet bowl to monitor someone's health via urine analysis. U-Scan is a reader with changeable analysis cartridges that examines urine for specific biomarkers and forwards insights to the Withings Health Mate app daily. In 2022, Withings unveiled Sleep Analyzer, an under-the-mattress sleep-tracking mat designed to detect sleep apnea. That same year, Medable partnered with Withings Health Solutions to use the company's connected devices for decentralized clinical trials. The alliance allowed Withings' tools for remote monitoring, like connected scales, blood pressure monitors and sleep-tracking mats, to gather patient data and combine with Medable's clinical trial platform.

Connected health technology company Withings announced it has received FDA 510(k) clearance for its Sleep Rx Mat, a noninvasive, contactless device designed to diagnose sleep apnea at home. Among the Sleep Rx Mat features, a pneumatic sensor measures respiratory rate, body movement and continuous heart rate, along with sleep cycles, duration and interruptions, while sound and motion sensors detect snoring and breathing disturbances. "We’re thrilled to bring Sleep Rx to the U.S. market," Antoine Robiliard, vice president of Withings Health Solutions, said in a statement. "Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm. We know that a one-night assessment is not sufficient." THE LARGER TREND In 2023, Withings launched U-Scan, a biomarker-assessment platform that can be placed inside a toilet bowl to monitor an individual's health using urine analysis. The U-Scan reader comes with changeable analysis cartridges that analyzes a person's urine for specific biomarkers and sends insights to the Withings Health Mate app daily. In 2022, Medable partnered with Withing to use the company's connected devices for decentralized clinical trials. The alliance allowed Withings' tools for remote monitoring, like connected scales, blood pressure monitors and sleep-tracking mats to collect patient data and integrate with Medable's clinical trial platform. That same year, Withings unveiled a remote patient-monitoring program called Withings RPM, which utilizes the company's connected devices, such as scales, watches, thermometers and blood pressure cuffs to monitor patient metrics, including heart rate, activity, blood pressure and sleep patterns. Children's National Hospital, Texas Tech University Health Sciences Center, Arcare and AbleTo are facilities practicing quality telemedicine and delivering care to underserved populations, says Dr. Shawn Griffin, president and CEO at URAC. Children's National Hospital, Texas Tech University Health Sciences Center, Arcare and AbleTo are facilities practicing quality telemedicine and delivering care to underserved populations, says Dr. Shawn Griffin, president and CEO at URAC.

In this episode, the third and final conversation of our mini-series on diversity in clinical trials, Lori and guests discuss framing strategies designed to protect DEI initiatives from legal challenges. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart As the legal landscape continues to evolve, the uncertainty surrounding diversity, equity and inclusion (DEI) initiatives increases though the life sciences industry continues to move forward with DEI initiatives to include all patients in clinical trials. In this episode, our guests discuss framing strategies designed to protect DEI initiatives from legal challenges. Additionally, the guests acknowledge the importance of clinical trial sites in gaining patient trust. We also address the increased burden technology is putting on the sites as well as patients, suggesting potential ways to reduce these burdens. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ , Head of Insights, BioSpace Guests ⁠⁠Otis Johnson, PhD, MPA⁠⁠ , Principal Consultant and Co-founder, Trial Equity ⁠⁠Pamela Tenaerts, MD, MBA⁠⁠ , Chief Science Officer, Medable ⁠⁠Chris Hart,⁠⁠ Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag LLP ⁠⁠Patrick Floody⁠⁠ , Executive Director, Global Clinical Trial Services, Regeneron ⁠⁠Ken Getz⁠⁠ , Executive Director, Tufts Center for the Study of Drug Development; Professor, Tufts University School of Medicine Disclaimer: The views expressed in this discussion by Patrick Floody are his own and do not represent those of Regeneron.