- FDA Proposes Rules for Devices Using Artificial Intelligence
"Real-time, at-home monitoring of vitals allows our team to proactively act on early signs of health decline, preventing avoidable hospitalizations," said Neta Faynboym MD, CPE Executive Director, Innovation: Medicare Advantage/Affordability, at Banner Health.
Current Health passively measures a patient’s vital signs with its upper-arm wearable. Current’s proprietary algorithms continuously analyze data to derive a patient’s health trajectory by detecting indicators of patient decline for faster intervention.
The company said that it has received FDA clearance for its remote patient monitoring and telehealth platform, which includes Bluetooth integrations with other devices to track metrics. Patients receive a tablet equipped with a chatbot, medication reminders and educational content, which lets patients connect with clinicians via video chat or text message to report symptoms and discuss care.
The FDA also cleared a wearable electrocardiogram device that detects the most common heart arrhythmias.
The AliveCore device, called KardiaMobile, can detect atrial fibrillation (AFib), normal sinus rhythm, bradycardia, and tachycardia.
Bradycardia and tachycardia, which mean “slow heart” and “fast heart,” respectively, occur in nearly all adults. While the normal range of heart rate is between 50 and 100 beats per minute, there are scenarios where the rate can be slightly out of this range.
While bradycardia and tachycardia are often benign, they can indicate heart disease or other health conditions, such as thyroid disease. A slow or fast heart rate may be asymptomatic, or cause symptoms such as dizziness or shortness of breath.
KardiaMobile provides analysis indicating arrhythmias that are not AFib and that are between 40 and 50 beats per minute (bradycardia) or between 100 and 140 beats per minute (tachycardia).
Tachycardia and bradycardia are common because they are often the body's natural response to everyday life, from physical activity and sleep to emotions and overall health," said AliveCor CMO Jacqueline Shreibati.
"While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health, Shreibati added.
The FDA also recently approved a digital therapeutic platform to help children between the ages 7 and 12 with attention deficit hyperactivity disorder (ADHD).
Instead of using drugs to treat ADHD, the cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch on the patient's forehead, just above the eyebrows.
The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. Neuroimaging studies have shown that the Monarch external trigeminal nerve stimulation (eTNS) device increases activity in the brain regions that are known to be important in regulating attention, emotion, and behavior.
“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.
“Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs,” Peña added.