Withings Health Solutions Wins FDA Clearance of BPM Pro 2

The U.S. Food and Drug Administration (FDA) has cleared Withings Health Solutions’ BPM Pro 2, a first-of-its-kind cellular blood pressure monitor that integrates and automates many aspects of clinical workflows. The product is now officially authorized to measure blood pressure and pulse rate in adults with arm circumferences of nine to 17 inches (22 cm to 42 cm) or 16 to 20 inches (40 to 52 cm).

BPM Pro 2 empowers care teams to scale remote patient monitoring and streamline operations by addressing a critical challenge in remote care: ensuring that patients take more reliable at-home blood pressure measurements under optimal conditions and empowering care teams with valuable patient-reported outcomes. It accomplishes this through an engaging, vibrant color screen that continuously educates patients on the way to take the measurements correctly while also adding new insights and precision.

In addition to the FDA clearance, BPM Pro 2 has been named a CES 2025 Innovation Awards Honoree in the Digital Health category.

A New Era of Remote Monitoring

Seen in action below, BPM Pro 2 goes beyond traditional health monitoring, according to Withings. It collects highly precise measurements while also introducing a new feature that enriches data with daily life context thanks to the Patient Insights feature.

With Patient Insights, simple and customized questions can be asked to patients on the device’s screen to capture additional information such as symptoms, medication adherence, and screening questionnaires. This functionality enables a more comprehensive understanding of each reading while also reducing clinical workloads, freeing up care teams to dedicate time to patients with the highest needs.

The Patient Insights feature integrates seamlessly into clinical workflows, automates key tasks for care teams, and allows care providers to ask patients simple and customized questions. This device combines the power of real-time data capture with actionable insights, reducing the time, cost, and effort required for care teams to stay connected with patients.

In addition, the Retake Measure feature prompts patients to retake a reading if results exceed predetermined thresholds, reducing follow-up calls and ensuring measurement reliability.

By automating processes like symptom tracking, measurement prompts, and reminders, BPM Pro 2 significantly decreases the need for manual patient outreach, allowing healthcare providers to focus more on delivering quality care.

Elevated Patient Experience

BPM Pro 2 is designed with features that actively support and engage patients on their health journey:

• Personalized Health Nudges: Care teams can send customized messages, reminders, and motivational support directly to the patient’s device, keeping the patient engaged and promoting healthy habits.
• Accessible Design: Bold text and a color-coded feedback system enhance readability, with results highlighted in distinct colors for quick and easy interpretation.
• Seamless Connectivity: The device syncs instantly through cellular connectivity, allowing healthcare providers to access patient data on Withings RPM or their own clinical platform. For patients in areas with limited cellular coverage, BPM Pro 2 offers fallback options (WiFi and Bluetooth), ensuring that no patient is left behind.

“We are thrilled BPM Pro 2 is now FDA-cleared, this device marks a significant advancement in remote patient monitoring,” Withings Health Solutions Vice President Antoine Robiliard said. “BPM Pro 2 not only delivers precise, clinically meaningful blood pressure and pulse rate measurements but also empowers care teams with real-time insights and direct patient engagement tools. This milestone, along with the recognition as a CES 2025 Innovation Awards Honoree, underscores our commitment to creating solutions that streamline workflows, enhance patient involvement, and set new standards for the quality and reliability of remote care.”

Withings BPM Pro 2 is immediately available to health professionals and care teams. With a separate FDA clearance (expected next year), BPM Pro 2 will be able to take a one-lead ECG to detect atrial fibrillation.

Withings Health Solutions is a division of global connected health provider Withings, serving healthcare professionals across chronic disease prevention and management, remote patient monitoring, clinical research, and more. It aims to bridge the gap between patients and their care teams by continuously and effortlessly providing healthcare professionals with medical-grade data generated by patients from an ecosystem of connected devices.

Withings created the first smart scale in 2009 and has been the pioneer in connected health since then. Its clinically validated range is used by millions worldwide and include smart scales, hybrid watches, blood pressure monitors, sleep analyzers, and more.  For more than 15 years, Withings has built expertise in user experience, engagement, and retention. Withings Health Solutions extends this expertise to the healthcare industry to remove friction in the patient’s journey and allow digital health to expand.