FDA

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 Dave Muoio and Laura Lovett 03:45 pm September 27, 2019
It’s been two years since the first software-only digital therapeutic got the FDA greenlight, but the industry is still very much in its infancy and continuing to evolve. New entrances are emerging from the world of health, pharma, tech and finance. As the industry matures, it's grappling with existential questions including regulation, reimbursement models and, as always, the definition of a...
By Dave Muoio 02:50 pm September 26, 2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...
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 Leontina Postelnicu 10:59 am August 27, 2019
There is no shortage of fertility apps out there for women looking to get - or not get - pregnant. However, when it comes to figuring out the best options for fertility, one-size-fits-all might not be the best method. New research out of Nature Digital Medicine found that only 13% of women had menstrual cycles that are 28 days in length. Authors of the large-scale study, published this week,...
By Laura Lovett 03:35 pm August 26, 2019
In early August, the FDA issued a Class 2 Device Recall for Visibly’s Online Refraction Vision Test, stating that the company did not receive authorization from the FDA to market the product. According to the recall, Visibly has already initiated the recall.  This back and forth between the Chicago-based startup (formerly known as Opternative) and the FDA has been going on for a couple of years....
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...