FDA clearance

By Dave Muoio May 15, 2019
Aidoc, an Israeli provider of artificial intelligence products for radiologists, announced today that it has received FDA clearance for a tool that identifies potential cases of pulmonary embolism — a blockage in one of the lung’s pulmonary arteries — for expert review. “We chose to focus on this product because these are patients who might not necessarily have clear symptoms of pulmonary...
By Dave Muoio May 13, 2019
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced yesterday that it has received an 510(k) clearance for an artificial intelligence tool that can read medical imaging to identify potential cases of pneumothorax — a build-up of gas between a lung and the chest wall. The HealthPNX product scans a chest X-ray or digital radiography scan for signs of the condition,...
By Dave Muoio 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...
By Dave Muoio May 7, 2019
The FDA has cleared eMurmur ID, a software screening device that uses a smartphone, third-party digital stethoscope and machine learning to automate the detection of heart murmurs. According to Ottawa, Canada-based eMurmur, the cloud tool identifies and classifies both dangerous and healthy heart murmurs, as well as the absence of a murmur and S1 or S2 heart sounds. The platform includes a mobile...
By Dave Muoio May 2, 2019
The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias. According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias,...
By Dave Muoio April 24, 2019
In February, Edinburgh, Scotland-based Current Health (formerly snap40) received FDA clearance for clinical use of its artificial intelligence-enabled device and platform for remote patient monitoring in the hospital. Taking things one step further, the company announced this morning that it has also received the regulator’s blessing for use in post-acute care — what Current Health is calling “...
By Dave Muoio 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...
By Laura Lovett February 25, 2019
This morning Spirosure, a health tech company focused on respiratory conditions, announced that its latest product the Fenom Pro Asthma Monitor has landed FDA clearance. The provider-facing technology enables clinicians to measure the fraction of exhaled nitric oxide (FeNO), an indicator of airway inflammation, in their patient’s breath. The technology uses proprietary algorithms to detect the...
By Leontina Postelnicu February 6, 2019
Edinburgh-headquartered Current Health, formerly known as snap40, has received FDA Class II clearance for its remote patient monitoring solution, the Scottish start-up announced today. Current's AI-enabled wearable monitors vital signs with “ICU-level accuracy”, according to the start-up, and proprietary algorithms analyse data to offer insights into a patient’s health, alerting staff in case...
By Laura Lovett January 18, 2019
This morning Alphabet’s life science subsidiary Verily announced that its Verily Study Watch and its on-demand ECG feature landed a 510(k) clearance from the FDA. The watch is a prescription-only device, and was designed to record, store, transfer and display single-channel ECG rhythms. The company said the device’s ability to take on-demand, single-lead ECG can be used for individual patient...