Sam Brusco, Associate Editor08.30.23
AION Biosystems, a remote patient monitoring company, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its iTempShield quarter-sized, skin-wearable continuous monitoring device.
iTempShield was cleared for patients five years and older in hospitals, outpatient facilities, remote monitoring environments, and over-the-counter sale.
The device and software system allow continuous body temperature measurement for applications like oncology sepsis monitoring, post-surgical infection detection, long-term care monitoring, and home health for consumers. AION said its primary focus with be on early detection of infection in cancer patients and long-term care residents.
iTempShield adheres to the chest’s surface and can run without recharging for up to 60 days. This battery life makes it eligible for reimbursement in hospitals and health systems via CMS CPT codes for remote patient monitoring.
The company says iTempShield is four times more accurate than an oral thermometer because it calculates body temperature by leveraging a sophisticated library of AI-powered algorithms. It’s currently in use at Ellis Medicine’s Roswell Park Cancer Institute and being broadly deployed across Schenectady, N.Y. in a Smart City Program.
“iTempShield has the potential to be a ‘game changer’ for the management of cancer patients and other immunocompromised populations who are at heightened risk of infection,” Dr. Nicholas Montalto, chief medical officer of Ellis Medicine told the press. “By providing accurate continuous body temperature over a meaningful period of time, it allows us to keep our eyes on our patients wherever they are so that we can detect and treat infection before it becomes life-threatening.”
iTempShield’s remote monitoring platform sends an alert if body temperature exceeds a preset threshold over a given period. AION said it’s available at scale for early detection of infection and sepsis.
“Our iTempShield device and platform can literally mean the difference between getting an antibiotic prescription at home and a trip to the emergency room that ends in the ICU,” said Samara Barend, AION Biosystems CEO. “Our goal is to make remote patient monitoring so easy, accurate and cost-effective that anyone, anywhere can benefit from its life-saving capabilities.”
iTempShield was cleared for patients five years and older in hospitals, outpatient facilities, remote monitoring environments, and over-the-counter sale.
The device and software system allow continuous body temperature measurement for applications like oncology sepsis monitoring, post-surgical infection detection, long-term care monitoring, and home health for consumers. AION said its primary focus with be on early detection of infection in cancer patients and long-term care residents.
iTempShield adheres to the chest’s surface and can run without recharging for up to 60 days. This battery life makes it eligible for reimbursement in hospitals and health systems via CMS CPT codes for remote patient monitoring.
The company says iTempShield is four times more accurate than an oral thermometer because it calculates body temperature by leveraging a sophisticated library of AI-powered algorithms. It’s currently in use at Ellis Medicine’s Roswell Park Cancer Institute and being broadly deployed across Schenectady, N.Y. in a Smart City Program.
“iTempShield has the potential to be a ‘game changer’ for the management of cancer patients and other immunocompromised populations who are at heightened risk of infection,” Dr. Nicholas Montalto, chief medical officer of Ellis Medicine told the press. “By providing accurate continuous body temperature over a meaningful period of time, it allows us to keep our eyes on our patients wherever they are so that we can detect and treat infection before it becomes life-threatening.”
iTempShield’s remote monitoring platform sends an alert if body temperature exceeds a preset threshold over a given period. AION said it’s available at scale for early detection of infection and sepsis.
“Our iTempShield device and platform can literally mean the difference between getting an antibiotic prescription at home and a trip to the emergency room that ends in the ICU,” said Samara Barend, AION Biosystems CEO. “Our goal is to make remote patient monitoring so easy, accurate and cost-effective that anyone, anywhere can benefit from its life-saving capabilities.”