FDA

By Dave Muoio 04:03 pm December 9, 2019
Gainesville, Florida-based etectRx has received FDA 510(k) clearance for its ID-Cap System, a prescription ingestible system that sends adherence event logs to an external medical device. Similar to the system pioneered by etectRx’s high-profile competitor, Proteus Digital Health, the ID-Cap’s core is a standard capsule containing a sensor that transmits a message once it comes into contact with...
By Dave Muoio 03:56 pm December 5, 2019
#Pelotonad. Peloton has found itself in the middle of controversy as a recent television ad released by the company was panned by many as sexist. The roughly 30-second video, in which a husband purchases the connected exercise bike for his wife as a Christmas gift, has generated a backlash consisting of Twitter hashtags, viral parodies and a roughly 10% drop in Peloton’s stock price; however, the...
By Dave Muoio 03:00 pm December 5, 2019
The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions. Called CURE ID, the online data repository will allow clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections. In particular, the tool captures clinical outcomes in cases...
By Dave Muoio 04:37 pm December 4, 2019
Dr. John Halamka, a longtime CIO, executive director and professor tied to Harvard-affiliated Beth Israel Deaconness Medical Center, will be joining the Mayo Clinic on January 1 as the new president of its Mayo Clinic Platform — a digital health project that will deploy “artificial intelligence, the internet of things and an ecosystem of partners,” he wrote in a blog post announcing the move....
By Dave Muoio 04:07 pm November 19, 2019
Device regulation is a hurdle for any medical tech company, but doubly so for startups hoping to strike it big with their very first digital health product. With limited resources and experience, pushing a device through the FDA’s door and onto the market is a multi-year gauntlet of validation, documentation and, unfortunately, frustration. To help young companies take a bit of the guesswork out...

The 510 (K) clearance, pre-market submission, will enable the business to make EchoGo available to clinicians and healthcare providers in the US.

By Tammy Lovell 02:08 am November 18, 2019
UK-based health technology firm Ultromics has received clearance from the US Food and Drug Administration (FDA) for its cardiovascular image analysis system, EchoGo Core. EchoGo applies artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans. The 510 (K) clearance, pre-market submission, will enable the business to make EchoGo available to...
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...