FDA 510(k)

By Dave Muoio 04:23 pm October 1, 2019
Edinburgh, Scotland-based patient monitoring wearable and platform company Current Health (formerly snap40) has cut deals with fellow connected monitor maker VivaLNK and spirometry device company MIR (Medical International Research) to add axillary temperature and spirometry measurement capabilities to its offering. Enabled by a 510(k) clearance posted by the FDA back in July, these types of...
By Dave Muoio 09:44 am September 12, 2019
Israeli smartphone urinalysis startup Healthy.io has closed a $60 million Series C funding round led by Corner Ventures, the company announced this morning. Joy Capital Ventures and prior backers Ansonia Holdings, Aleph and Samsung NEXT each participated as well. Furthermore, the company also announced that it has received a second FDA 510(k) clearance intended to support diagnosis of chronic...
By Dave Muoio 11:45 am August 29, 2019
Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate. Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a...
By Dave Muoio 03:11 pm July 30, 2019
PhysIQ has received 510(k) clearance for an algorithm facilitating cloud-based analysis of patients’ continuous ambulatory respiration rates, according to an update to the FDA’s device clearance database that was confirmed by the company to MobiHealthNews. This regulatory clearance is the company’s third, and like its predecessors uses artificial intelligence to characterize raw sensor data as...
By Laura Lovett 03:14 pm July 15, 2019
This morning Teva Pharmaceutical Industries announced that the FDA greenlighted its AirDuo Digihaler, a sensor-enabled inhaler. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user's smartphone. This information can also be sent to the user’s provider.  The sensor technology is also able to monitor inspiratory flow...
By Dave Muoio 02:30 pm June 17, 2019
The past week has seen two FDA clearances awarded to Israeli companies building artificial intelligence analysis tools for medical imaging. The first, announced last Tuesday, was Aidoc’s tool for triaging cervical spine fractures. Much like the company’s prior offerings, the new product analyzes images to prioritize high-risk cases for review by a radiologist, and does so within the specialist’s...
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 Jonah Comstock 02:36 pm March 21, 2019
This article has been updated with a new photo and additional information from Omron. Omron has apparently finally received FDA 510(k) clearance for its Blood Pressure Monitor + EKG device, which was originally announced in January 2018 at CES. The device was created in partnership with AliveCor. This is a separate product from Omron's HeartGuide watch, which also incorporates AliveCor ECG...
By Jonah Comstock 12:56 pm February 28, 2019
Toronto-based CardioComm, a longtime player in the handheld personal ECG space will finally make data available on consumers' smartphones with a new 510(k) clearance for its GEMS Mobile smartphone app, which works on both iOS and Android devices. The company also received clearance for a new ECG device called HeartCheck CardiBeat.  Notably, these are over the counter clearances, allowing the app...