Monday, July 8, 2019

Physician Tips: How Are Wearables Are Disrupting Healthcare




For Fibronistics

Second in a series on wearable healthcare devices

Imagine a future where the clothing and accessories continuously send health-related data for your patients to their own patient-specific databases. The data is monitored by artificial intelligence that can distinguish between an anomaly that is little more than a blip, and one that may be cause for alarm. An alert is sent to a data analyst, who determines whether diagnostic testing is warranted, if so a consultation with you is arranged. (published site)

Medical wearables with artificial intelligence and big data promise to add value to healthcare with a focus on diagnosis, treatment, patient monitoring and prevention. And that future may be closer than you might think.

Wearable medical devices for tracking a wearer’s vital signs or health and fitness related data, are going through a digital revolution. The Wearable Medical device market can be segmented by application: sports fitness, remote patient monitoring and home healthcare.

While much of the media attention has gone to the sports/fitness segment, many see the mobile patient monitoring and home healthcare monitoring as the segments where healthcare will see the greatest impact.

With this in mind, the National Broadband Plan drafted by the Federal Communications Commission (FCC) paid special attention to healthcare and remote patient monitoring in conjunction with EHR (Electronic Health Records) citing the potential benefit to the healthcare industry of saving $700 billion over the next 15 to 20 years.



Already remote patient monitoring includes daily Continuous Glucose Monitoring (CGM) devices such as the FDA-approved Dexcom G6 for patients with diabetes. What sets the Dexcom system apart from others is that it is the first to receive FDA approval as new class II device to be used as part of an integrated system with other compatible medical devices and electronic interfaces.




It doesn’t require a receiver it can talk directly to an app on a smartphone or a compatible insulin pump. As such it can adjust insulin delivery based on readings. The Medicare-covered device competes with similar devices such as Abbott’s FreeStyle Libre and Medtronic’s standalone Guardian Connect.

In cardiology, companies working to change remote patient monitor include Bardy Diagnostics, which makes the CAMTM patch to compete with similar arrhythmia monitoring devices.


In a study published in the American Heart Journal late last year compared the CAM patch to the Zio XT patch. Led by electrophysiologist Robert Rho, M.D., FHRS, FACC, the study followed 30 patients simultaneously who wore the Zio XT pectoral patch and the CAM sternum patch, which is a P-wave centric arrhythmia monitoring device.


The study called for recording data continuously for 7 days with outcome measures comparing diagnostic yield, ECG signal clarity, ease of use and comfort, together with an assessment of differences in clinical decision-making based upon each device's rhythm diagnosis.

The results showed the P-wave detection approach used by the CAMTM patch, identified significantly more arrhythmias and resulted in better, more informed clinical decision-making over the iRhythm Zio XT patch.

A similar study compared the CAM patch to the current Holter monitoring system in 50 patients. Results showed the P-wave CAM patch identified management-altering rhythms in 23 patients (46%), compared to 6 Holter patients (12%). In terms of comfort, 96% of patients preferred wearing the CAM patch.

The easy-to-apply CAM patch can be worn during normal daily activities including exercise, showering, and sleep for up to seven days. The CAM patch is linked to a suite of ECG analysis services and tools. After data are collected, a secure web-based portal provides a single system for uploading and analyzing ECG data, accessing and managing patient reports and provides a comprehensive, flexible solution that improves workflow and convenience for clinicians.


In the home health monitoring segment Biovotion hopes its Everion multisensory wrist-device will replace multiple hospital devices that monitor vital signs and 17 other medical parameters. Working with Microsoft, IBM Research, the Mayo Clinic and others, this company is developing a device worn on the upper arm, where it collects real time data, continuously, non-invasively, 24/7.




The vital sign parameters collected are comparable to what would be collected in a low-acuity environment in a clinical setting and include heart rate, skin temperature, respiratory rate, and blood oxygenation. Additional clinical and non-clinical parameters (blood pulse wave, activity and steps, energy expenditure, sleep, heart rate variability, Inter-beat-interval & stress provide added insights. While the Switzerland-based company has been granted CE Mark for the device it has yet to receive FDA clearance.

One feature of the Everion that sets it apart is that it uses PPG, or photoplethsysmography to generate its readings. In a recent study of the Everion with other wearable devices, including the Holter monitor the company claims the Everion performed as well as the Holter during intense activity. Throughout its testing, the company has found the Everion’s datasets to be “comparable and showing excellent agreement with respect to the Holter across the entire range of tested activities,” and suggests that PPG is a strong alternative to ECG, particularly when long-term data collection is required. 

The company has partnered with UK-based CareRooms that provides equipment and services to hospital patients discharged to home care. With theEverion, CareRooms plans to track patient heart rate, skin temperature, stress, blood oxygenation and steps to provides regular assessments that they would ordinarily get in a hospital, to ensure patient recovery.

Other medical-grade wearable devices are being introduced everyday as companies seek to gain a competitive edge in healthcare, and the competition is rapidly changing the way patients connect with their providers, and healthcare systems.

Fibronostics is committed to partnering with physicians and providers to improve patient care by offering the benefits of technology to improve lives,and deliver high-quality, life-improving disease education, evaluation and monitoring.

For more information contact us via email, or by phone at 1-888-552-1603.


Second in a series on wearable healthcare devices

Digital technology is transforming healthcare allowing service providers to create a strong and evaluative infrastructure that can focus on a specific patient’s needs as never before. It is transforming the patient-doctor relationship, and the development of wearable medical devices promises to completely change the way patients access, and experience healthcare.


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