FDA

By Dave Muoio 03:03 pm November 5, 2019
Friday marked the end of Dr. Ned Sharpless’ time as acting commissioner of the FDA, with President Donald Trump pointing to Dr. Stephen Hahn, currently the chief medical officer of MD Anderson Cancer Center, as his official appointment for the role on Friday. Assistant Secretary for health at HHS Dr. Brett Giroir will act as the agency’s new acting head. “With Dr. Sharpless at the helm, the FDA...
By Dave Muoio 12:00 pm November 5, 2019
Type 1 diabetes management and CGM integration are now on the table for WellDoc’s BlueStar, a management platform well known for being the first mobile health product to secure reimbursement as a diabetes therapy. Thanks to a new FDA clearance, the company’s seventh, BlueStar will include integrated glucose level insights related to food, medication and activity that are based on the data from...
By Bradley Merrill Thompson 02:08 pm November 1, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS. Let’s say I could show you,...

Photo by Sean Rayford/Getty Images

By Laura Lovett 12:54 pm October 30, 2019
US senators Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.) have penned another letter to the FDA expressing concern over the agency’s PreCert program.  In it, the senators acknowledge the opportunities for digital health, but also question the proposed regulation's ability to ensure safety of the products. The 10-page letter asks 18 pointed questions about the program...
By Dave Muoio 03:32 pm October 28, 2019
The past few days have seen new pivotal trial announcements from two startups eyeing FDA submissions for their digital health offerings. On Thursday Cognoa unveiled an investigation for its pediatric development monitoring and diagnostic tool. This will be a multi-site, prospective, blinded, active comparator study of the tool, which is intended to support primary care autism diagnoses among...
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...