- Autoimmune Disorders in Women Possibly Triggered by Seafood
- FDA Approves Noninvasive Colorrectal Cancer Test
- FDA Approves Limited Use of Drug for Ebola
- FDA Approves Edwards Lifesciences Corporation’s Sapien XT
- Lymphoseek Injections Approved by FDA for Prolonged Extended Use
- Orexigen Therapeutics’ Contrave Awaits FDA’s Nod
- FDA Expressed Concern on E-Cigarette Smoking after Increase in Complaint Rate
- E-Cigarette Marketing to Be Regulated by FDA Appealed As They Pose Serious Threat to the Youth
- FDA Goes Tough on Honey with Added Sweeteners
- Is Your Honey Adulterated?
Heart Function Monitoring Mobile Device Approved by FDA
- Updated: September 1, 2014
Currently, heart disease is the leading cause of death in the United States, causing an estimated 600,000 deaths annually. According to AliveCor’s Chief Executive, Euan Thomson, it is very difficult to identify atrial fibrillation and in fact, not only are there many people who have it, most are completely unaware.
Because of this, researchers and scientists have used modern day technology to their advantage, as seen in new heart health tracking applications available on smartphones. For people who do not realize they have atrial fibrillation, as well as individuals with known heart problems, an application such as this could mean the difference between life and death.
Two Unique Approaches to Heart Monitoring
Just this week, the United States Food and Drug Administration (FDA) approved cell phone applications for two startup companies in the Silicon Valley. With these applications, patients will have the ability to monitor heart health in the privacy and comfort of home. For years, experts in the digital health industry have been asking the FDA for more regulation clarity so this latest approval is huge for obtaining that information.
The first company to get the FDA’s nod of approval is AliveCor. This company will offer a mobile device application whereby Electrocardiogram (ECG) readings will help detect serious heart conditions. This new application is designed to detect a form of cardiac arrhythmia known as atrial fibrillation. Success rate for adults over the age of 40 is one out of every four individuals.
However, if an abnormality were detected, it would be critical for that person to seek medical attention, thereby averting a heart attack, stroke, or perhaps death. According to Thomas, an ECG is recorded by resting the smartphone on the person’s chest or finger, and is designed to fit most smartphones on the market. Now that AliveCor received approval by the FDA, the company anticipates having the application available by September 2014.
Vital Connect is the second company that received FDA approval although in their case, it was for a patch called the “HealthPatch MD”. Compared to the mobile device offered by AliveCor, there are a number of differences with Vital Connect’s patch to include embedded sensor design for greater function monitoring, available only with a doctor’s prescription, and data put into context according to situations.
Although the approach to heart health monitoring is quite unique to AliveCor and Vital Connect, both companies have the same vision of making it easier for doctors to monitor patients remotely but more importantly, preventing possible heart attack, stroke, or death. Using the gathered data in both instances would also help doctors get patients in for an examination or visit to the hospital ER.