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...
July 30, 2019
Looking to solve the problem of health record interoperability, this afternoon CMS unveiled a new pilot program dubbed “Data at the Point of Care” (DPC), which will employ an API to help give providers access to their patient’s medical data. The pilot is part of a larger CMS initiative called MyHealthEData, which is focused on giving patients more access to their medical data.
“That burden on...
July 26, 2019
Verily’s Luba Greenwood has told MobiHealthNews that she left the Alphabet subsidiary to pursue lecturing at Harvard University as well continue her work on several boards.
Greenwood took up her role at Verily, where she served as business development manager, in February of 2018. According to Verily officials Greenwood left the company in April. In a recent interview with MobiHealthNews,...
July 25, 2019
In the US the percentage of people living with loneliness is rapidly increasing. This is particularly true when it comes to young people, about half of whom report living with loneliness.
Chronic loneliness is linked to a number of health conditions including depression and Type 2 diabetes, with the CDC reporting that it is more dangerous than obesity and as damaging as smoking 15 cigarettes a...
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...
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...
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...
July 16, 2019
The stakes are high when it comes to medical device safety, but recall notifications aren’t always easy to find.
With this in mind, a new Boston-based startup called Soom is aiming to target this issue with its new app, called SoomSafety. The app lets users scan the bar code of a medical device to bring up all safety and recall information about the product.
Soom pulls from the FDA’s open-source...
July 15, 2019
Patients who enrolled in a physical activity trial enjoyed a long-term benefit of fewer cardiovascular events and bone fractures up to four years after the intervention was completed.
According to a new review of these patients’ routine primary care records published in PLoS Medicine, the data support further rollout of pedometer-based walking programs among older adults, even if the intervention...
July 12, 2019
Deep in the belly of the University of Helsinki, large metallic cylinders line a basement lab. While the setting is clinical, scientists have added a playful touch with snow-themed name tags on each of the vats. Still, the mission of the lab is serious — inside “snow queen” and “snow castle” lie genetic samples that could potentially help decode genetic variants responsible for disease.