July 19, 2019
This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb to its new commissioner, Dr. Norman "Ned" Sharpless.
Among its most notable digital health actions of the past few months was the agency’s decision to put out a call for new companies to try out the current framework of its Digital...
May 13, 2019
Mobile consumer ECG maker AliveCor announced today that its long-teased six-lead ECG device has been cleared by the FDA and will be available to customers in June of this year.
“[The KardiaMobile 6L clearance] is a big deal for us, and it’s important for patients and physicians because they will be able to get a materially improved view into patients’ hearts,” Dr. Jacqueline Shreibati, chief...
April 15, 2019
Another recent update to the FDA’s 510(k) premarket notification database suggests that AliveCor is inching closer and closer to its next volley of smartphone-connected ECG products.
According to the agency, the digital health company received clearance related to its consumer KardiaMobile platform, as well as the clinician-facing KardiaStation, on Friday. The application for the device or...
March 4, 2019
A&E departments in the UK should introduce AliveCor’s KardiaMobile device into standard care, researchers have said, for patients presenting with heart palpitations or feeling lightheaded, after a study found it was five times more effective than current tests used to diagnose heart rhythm problems.
Although often harmless, if patients fully recover before getting to A&E, detecting the...