Filtering by Tag: cardiac

The Apple Watch’s ECG features are live

The Apple Watch has a new free software update that allows for wrist-based ECGs on-the-go. Each ECG recording is saved in an iPhone app and can be shared as a PDF with physicians. The watch will also track a person’s pulse in the background and send the wearer a notification if it detects a possible atrial fibrillation, the most common form of irregular heart rhythm.

Categories: diagnostics, POC

Published on by Winnie So. Source.

Eko AI study demonstrates accurate digital diagnoses of pediatric heart murmurs without a specialist

Eko’s handheld device, the Duo, combines a digital stethoscope and electrocardiogram and was cleared by the FDA in June 2017. Eko has now developed a machine-learning AI that can detect heart murmurs in pediatric patients as accurately as a cardiologist. After receiving regulatory approval, Eko plans to roll out this new AI feature on the Duo.

Categories: diagnostics, POC
Tags: cardiac

Published on by Winnie So. Source.

Siemens gets FDA clearance for high-sensitivity troponin assays

Siemens’ two high-sensitivity troponin assays can detect lower levels of troponin in serum or plasma compared to traditional assays. They have been available in Europe since May 2017 and have now been approved for use in the U.S. by the FDA.

The troponin I assays are to be used with the Siemens Healthineers’ Atellica IM and ADVIA Centaur XP/XPT in vitro laboratory analyzers.

Categories: diagnostics
Tags: cardiac, troponin

Published on by Winnie So. Source.

Alere pays $33M to settle claim it knowingly sold unreliable devices

Alere is paying the U.S. $33.2 million to settle claims it knowingly sold unreliable point-of-care testing devices to emergency departments. The government alleges Alere continued to sell Triage devices in the years running up to a 2012 recall despite receiving reports of erroneous results.

The false negatives and positives may have led patients with suspected heart failure, drug overdose and other serious conditions to receive inappropriate clinical management. 

Alere sold its Triage line to Quidel last year to obtain antitrust approval for its takeover by Abbott.

Categories: diagnostics, POC, lawsuit
Tags: Alere, FDA, cardiac

Published on by Winnie So. Source.