FDA clearance

By Laura Lovett 04:05 pm October 8, 2019
This morning the Dexcom G6 Pro Continuous Glucose Monitoring System got the greenlight from the FDA. The latest technology can gather real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode.  In blinded mode, patients don’t see their data automatically; instead, the clinician will get the data and then be able to discuss it with the...
By Dave Muoio 03:10 pm October 1, 2019
Sixth time's the charm? Roche’s Accu-Chek Connect Diabetes Management App has notched its sixth device recall from the FDA, this time due to meter-to-app data transfer issues for users with Android OS 8.0 and above. According to the agency’s posting, Roche notified partners, users and call centers of the issue and released and update addressing the problem before the end of that month. Prior to...
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 Laura Lovett 04:07 pm May 22, 2019
This morning the FDA granted digital physical therapy company Reflexion Health a 510(k) clearance for its Virtual Exercise Rehabilitation Assistant (VERA) to be used for trunk and upper extremities.  VERA is a prescription digital physical therapy platform that uses an avatar coach to help patients with their rehabilitation. The platform has the ability to perform a 3D scan of the patient in...
By Dave Muoio 03:01 pm 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 05:47 pm 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 08:42 am 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 11:43 am 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 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,...