In the past, medical device makers had comparatively simple tasks to perform, usually centered on monitoring hospitalized patients and producing tools – such as pacemakers – that fended off dangerous changes in the health of patients while they lived normal lives.
These days, however, as digital health models mature, device makers are under intense pressure to do more. They’re being asked to help clinicians and hospitals collect, compile and analyze patient data in real-time. More importantly, they’re being asked to find new approaches to tracking and managing patient data so physicians can respond quickly to subtle changes in the status of their patients.
Remote cardiac monitoring, in particular, has emerged as a target for device makers who realize that their products can close gaps in the existing toolset and offer life-saving benefits to a fragile population. Heart disease kills one person every 37 seconds in the US, a country that spends $219 billion per year on heart disease treatment alone, so the value of better monitoring is clear.
Ultimately, remote patient monitoring (RPM) is helping providers offer decentralized services that are gradually replacing many of those delivered inside hospital walls. With Medicare paying for remote monitoring, providers have every reason to get on board with RPM. And according to a 2019 study by Spyglass Consulting Group, they’re doing just that: 88% of providers they surveyed had either invested or were planning to invest in RPM technologies.
In this article, you’ll find a list of some companies tackling critical problems with remote monitoring technology for cardiac issues.
VitalConnect’s technology is part of a trend in which medical sensors are being used for a wide range of remote patient monitoring systems—mobile cardiac telemetry devices, mobile personal digital assistant systems, ambulatory wireless EEG recorders, and ambulatory event monitors.
The San Jose-based company makes wearable biosensor technology that can track patients’ condition as they move from hospital to home, returning as soon as possible to their daily routines. Its latest initiative is a remote monitoring solution to help cardiologists monitor patients who have or are at risk of arrhythmias.
VitalConnect’s Vista Solution 2.0 generates predictions based on National Early Warning Scores (NEWS), crunching patient data using predictive analytics to warn physicians when a patient’s health status is slipping. Vista Solution 2.0 was developed in collaboration with the Mercy Health System, whose Mercy Virtual division runs a large “virtual hospital” caring for patients remotely and via telemedicine channels.
The company’s VitalPatch biosensor collects a wide range of patient data points used to calculate NEWS, including single-lead EKG tracings, heart rate, heart rate variability, respiratory rate, and skin temperature. It also pulls in weight, blood pressure and pulse oximetry from third-party devices. With sophisticated tracking and alerts available wherever this technology is used, many patients who might have remained in the hospital can now head home safely and be monitored as outpatients. Continuous monitoring makes it more likely that physicians will get care to the patient quickly when something is seriously amiss.
Heart failure is a devastating condition affecting 26 million people worldwide, 50% of whom die within five years of being diagnosed. It’s also surprisingly common, with one in five people developing heart failure during their lifetime.
Steps patients can take to cut their risk of death include making appropriate lifestyle changes, participating in cardiac rehabilitation programs and taking prescribed medications. Far too often, though, patients don’t get the support they need to follow care recommendations. At the same time, given the complexity of managing heart failure, doctors may struggle to optimize medication regimens to meet individual needs.
Enter the Cordella System by Endotronix, based in Lisle, Illinois. The idea behind Cordella is to help physicians stay on top of patients’ status between office visits, and ultimately, avoid adverse events or death due to heart failure.
This bundle of smart measurement tools includes a smart blood pressure cuff, pulse oximeter, pulse monitor and smart scale. The most recent data points are gathered into a dashboard display.
The package also comes with the Cordella pulmonary artery pressure sensor, which is implanted in the patient’s heart, and a handheld reader the patient holds to their chest to collect cardiac status data.
Doctors who use the system track key clinical data on patients, then use that data to titrate the patient’s medication to an optimal level. They can check in with patients using the Cordella app, which helps patients stay on top of their care and take the daily readings needed to keep doctors up to date.
If you’ve had a health emergency recently, you may have encountered technology from ZOLL, whose products and software help clinicians, emergency medical technicians and firefighters, the military and non-professional rescuers provide life-saving care. These professionals may be the first caregiver a patient sees when they face a medical emergency.
Too often, however, emergency medical service personnel and firefighters don’t have access to key patient health data, in part because they don’t have the resources an emergency department can bring to bear. In many cases, they don’t even have access to their patient’s EHR, much less the data resources an emergency department has. All they may have to go on is the information relayed by whoever called 911.
In an effort to close this gap, ZOLL is creating mobile monitoring devices that can arm public safety responders with the support they need to care for patients in cardiac crises. These include tools like ZOLL’s LifeVest, a portable cardioverter-defibrillator worn directly against the patient’s skin that lowers the risk of sudden cardiac death.
Other ZOLL remote monitoring products include the AutoPulse Resuscitation System, which provides automated CPR, and the µCor Heart Failure and Arrhythmia Management System (HFAMS), which includes a sensor that can be worn by patients 24 hours a day.
HFAMS continuously records key data points such as the patient’s thoracic fluid index, heart rate, respiration, and heart rhythm, giving physicians access to important patient status data that might alert them to a deteriorating condition while giving emergency responders information useful to detecting cardiac arrest in patients they encounter in the field.
Unlike many of its peers, AliveCor sells its products directly to heart-health conscious consumers. While the data it collects can be shared with physicians, it’s designed primarily to allow patients with potential or existing cardiac arrhythmias to track the state of their heart rhythm.
Products like the company’s Kardia technology are not only getting patients engaged with their cardiac status, they’re making it possible for patients to share EKG results with cardiologists in near real-time, without being seen in a hospital emergency department.
AliveCor’s technology is addressing a pressing need. According to the CDC, about 5.3 million Americans have atrial fibrillation (AFib), and in 2014, this arrhythmia was the principal diagnosis in about 454,000 US hospitalizations. Patients with untreated cardiac arrhythmias are susceptible to other health problems and have five times the rate of stroke over patients whose condition is being managed.
The Mountain View, California, vendor makes two FDA-cleared mobile EKG technology devices designed to help people keep track of their symptoms. AliveCor backs up its reading with machine learning algorithms.
One of its products, the Kardia6L, generates results equivalent to a 6-lead EKG, and it can detect whether patients are experiencing atrial fibrillation, bradycardia, tachycardia or a normal heart rhythm. It takes the device 30 seconds to complete a reading. To use this device, patients put the one electrode against the skin of their left leg and place two fingers on the pair of electrodes on the opposite side.
Meanwhile, patients using KardiaMobile produce a reading using a simplified set of sensors and a smartphone. To set up this device, users download an associated app to their phone, connect the Kardia sensor strip to the phone and place their two thumbs on the sensor pads. The result is the equivalent of a one-lead EKG.
Unlike many medical devices, the two Kardia products are priced to be competitive with consumer electronics devices. At present, KardiaMobile sells for $99 and the Kardia6L for $149. Other remote monitoring devices made by long-standing medical device makers are far more costly to obtain and are managed by physicians or hospitals.
While Kardia products are consumer-based, physicians can gather and review the data using AliveCor’s KardiaPro software at no cost. In addition to allowing them to review EKG results, Kardia is designed to help physicians use CPT codes to bill insurance companies for their remote patient monitoring.
Each wave of digital health brings new challenges and opportunities. It is clear that this generation of medical devices will be asked to do more or risk falling behind. At Redox, we are committed to helping medical device manufacturers execute their big vision with our full-service interoperability platform. Discover what’s possible when health data from any system is accessible, exchangeable, and standardized.