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FDA Clears Withings’ BPM Pro 2 Blood Pressure Monitor for Remote Heart Failure Monitoring

by Amy

This week, the FDA approved Withings’ BPM Pro 2, a cellular blood pressure monitor designed to help healthcare providers manage heart failure patients through remote monitoring. The device aims to improve care for chronic heart failure patients, a leading cause of death in the U.S.

Withings, a France-based company, originally launched the BPM Pro 2 in October. The monitor’s FDA clearance marks a significant step forward in the use of technology for managing heart failure. The BPM Pro 2 is designed to help healthcare providers scale remote patient monitoring, offering a new tool for managing chronic conditions like hypertension, which is closely linked to heart failure.

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In the past, hypertension was typically managed through medication adjustments based on annual blood pressure readings taken during office visits. However, as Withings’ Antoine Robiliard, head of the company’s health solutions division, pointed out, this approach is neither accurate nor efficient. “It took the industry a while to realize that this is not an accurate or efficient way to monitor and manage patients’ blood pressure,” Robiliard said.

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To address this gap, the BPM Pro 2 allows clinicians to program contextual questions into the device. These questions are asked directly on the monitor while patients take their measurements at home, helping care teams gather important data about medication adherence and symptoms. Robiliard noted that one of the biggest challenges in managing hypertension is that many patients are unaware they have the condition or are not diligent about taking their medication. “Half of the population in the U.S. who are affected by hypertension don’t know about it, and those who do often don’t follow their medication,” he explained.

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The BPM Pro 2 not only tracks blood pressure but also collects data about symptoms and medication adherence, reducing the need for providers to spend time reaching out to patients for updates. This is especially important amid the ongoing workforce shortages in healthcare, Robiliard added. “The device makes it easier for nurses to monitor more patients, freeing up time for them to focus on patient care and behavior change rather than just asking routine questions.”

The BPM Pro 2 is also designed to improve measurement accuracy. It detects anomalies and sends automated prompts to users to retake their measurements, ensuring more reliable data. Additionally, the device reminds users to schedule follow-up appointments with their healthcare providers.

Withings plans to release the BPM Pro 2 in the U.S. on January 1. The device represents a significant step forward in remote healthcare technology, helping providers manage heart failure and hypertension more effectively and efficiently.

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