FDA clearance

By  Dave Muoio 01:37 pm 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 08:07 am 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 01:33 pm 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 01:50 pm 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 08:20 am 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 02:20 pm 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...
By  Dave Muoio 02:04 pm January 10, 2019
The FDA has granted 510(k) clearance to an over-the-counter handheld electronic device for treating hay fever sinus pains, according to an announcement from its manufacturer. Tivic Health Systems’ ClearUP Sinus Pain Relief device is non-invasive and does not rely on a pharmacological component. Instead, the single-button device is run along the skin of the user's cheek, nose and brow, where it...
By  Dave Muoio 01:46 pm December 18, 2018
The FDA has approved an app-based smart programming device used to discreetly and easily control implants treating for overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention, medical device maker Medtronic announced yesterday. Called the InterStim smart programmer and designed for use with Medtronic’s InterStim system, the product consists of a Samsung...
By  Laura Lovett 11:32 am December 10, 2018
Last week, the FDA granted a 510(k) clearance to POPS! Diabetes Care for its latest product, the POPS! one blood glucose monitoring system.  The system is made up of a diabetes coaching app and a small glucose meter that attaches to the back of a user’s smartphone. Users can check their glucose levels on the meter and the results will automatically transfer to the app. Users can track their...
By  Dave Muoio 02:28 pm November 28, 2018
Basking Ridge, New Jersey-based medical device maker Electrocore has received a 510(k) clearance expanding the label of its non-invasive vagus nerve stimulator (VNS) therapy device to include cluster headache prevention. According to a release from the company announcing the news, no other devices or pharmacologic treatments have received this indication from the agency. Therapy using the...