FDA clearances

By Dave Muoio 12:10 pm February 25, 2019
Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA. The cloud-based service leverages proprietary algorithms, users’ individual blood glucose data and a small team of in-house health professionals to generate and deliver insulin dosage...
By Laura Lovett 03:37 pm January 28, 2019
This morning medical device company Masimo announced FDA clearance for the measurement of respiration rate from a photoplethysmogram (RRp), so that it may now be used on the MightSat Rx finger pulse oximeter. The latest clearance also means the technology can be used at home by patients.   The new technology will be able to calculate a user’s respiration rate, which is the count of breaths per...
By Dave Muoio 03:47 pm December 31, 2018
Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020. Teva’s ProAir Digihaler is indicated for the...
By Dave Muoio 02:39 pm December 21, 2018
The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance. For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...
By Dave Muoio 11:48 am December 20, 2018
This morning, Omron Healthcare announced that the HeartGuide wristwatch — a wearable oscillometric wrist blood pressure monitor unveiled earlier this year at CES 2018 — has received FDA clearance and will be available at retail on January 9, 2019. The device is currently available for preorder for $499. The key feature of the product is a flexible synthetic band that is designed to inflate and...
By Laura Lovett 02:27 pm January 24, 2018
toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, has received a second FDA clearance. The new clearance will allow the company to update the software to add a new feature that measures stroke volume and cardiac output to the orginal product. The clearance also lets the device connect to a mobile application that allows medical...
By MobiHealthNews 02:00 pm December 21, 2017
In 2017, MobiHealthNews covered 51 devices that received clearance from the FDA. Along with a handful of diagnostic devices, disease management platforms, and novel monitors, this year boasted a few surprises from the agency, such as the approval of a direct-to-consumer genetic tests for disease risk and a purely digital intervention. The year also hosted its fair share of regulatory news and...
By Jeff Lagasse 02:51 pm July 21, 2017
The FDA has been a busy agency these past few months. The second quarter of 2017 has seen a flurry of clearances, many for technologies that continue the trend toward mobile, or even wearable devices. It’s been a good period for those with diabetes, sleep disorders and traumatic injury, not to mention those just looking to maintain and manage their health – with a little digital help, of course....
By Heather Mack 01:53 pm December 30, 2016
Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration. While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software clearances, as the regulatory agency continues to evolve its position and expertise on how to regulate digital health tools. It’s been an...
By Heather Mack 07:06 pm July 21, 2016
We’ve compiled a list of our FDA-related coverage for first half of 2016. Eighteen companies received clearance for their devices, one was declined, and one group of patients published an editorial about their relationship with the FDA. Also this year, the FDA came out with some new guidance about how medical device makers should make data available to patients. Read on for our roundup of...