FDA

By Dave Muoio 03:30 pm August 6, 2019
Paris, France-based Voluntis has received FDA marketing authorization for an algorithm-driven digital tool that helps cancer patients manage their symptoms and care teams identify clinical insights, the company announced last week. The Oleena software is a Class II medical device that is prescribed by the patient’s care team. As the user logs their symptoms into the app, it adapts to offer...
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 03:58 pm July 25, 2019
Healthcare artificial intelligence company Viz.ai announced that it is joining forces with Medtronic with the goal of speeding up adoption of the former’s technology. Specifically the pair will be working on getting Viz.ai’s system, which specializes on stroke detection, into more stroke treatment centers in the US.  “Medtronic is an innovative company focused on therapies that extend life and...
By Laura Lovett 02:23 pm July 23, 2019
A little over six months after the FDA moved its PreCert pilot along to the Test Plan phase, the agency released its Mid-Year Update on the program. At this stage, the original nine FDA PreCert pilot companies are now in the midst of test-driving the new Working Model. This means companies seeking to approve new products will go through the new PreCert pathway and the traditional review process...
By Dave Muoio 03:59 pm July 22, 2019
Prescription digital therapeutics company Pear Therapeutics announced late last week that it has filed an FDA marketing authorization for Somryst, its digital cognitive behavioral therapy for the treatment of adults with chronic insomnia and depression. While an approval from the agency would mark the third authorized prescription digital therapeutic for Pear — behind reSET for substance use...
By MobiHealthNews 03:19 pm July 19, 2019
This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb to its new commissioner, Dr. Norman "Ned" Sharpless.  Among its most notable digital health actions of the past few months was the agency’s decision to put out a call for new companies to try out the current framework of its Digital...
By Laura Lovett 03:48 pm July 17, 2019
WebMD’s consumer STD lab tests came under fire this week after Responsible Telemedicine, a nonprofit that bills itself as an "industry watchdog," filed a lawsuit suing the company for mislabeling the tests as FDA approved.  The suit alleges that only three of the nine STD tests sold by WebMD have “undergone the United States Food and Drug Administration (FDA) premarket approval process through...
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 Jonah Comstock 03:51 pm June 10, 2019
Caesarea, Israel-based Itamar Medical received FDA 510(k) clearance last week for a new disposable home sleep apnea test (HSAT) called WatchPAT One. The device is smartphone-connected; patients pair the wearable to their phone before sleeping with the device, which straps around the wrist but also includes a sensor that goes over the tip of the finger and another that affixes to the chest, both...