FDA clearance

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...

Photo credit: POPS! Diabetes Care

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...
By Dave Muoio 04:07 pm November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
By Dave Muoio 03:39 pm November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October. Results generated by the algorithm-based software are...
By Dave Muoio 05:45 pm October 31, 2018
Yesterday afternoon the FDA announced that it would permit 23andMe to market its Personal Genome Service Pharmacogenetic Reports test. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications. The purpose of this test is to inform patients and encourage them to more thoroughly...