Consumer

Screengrab of Circle DNA's official website.

By Dean Koh February 19, 2019
Beijing-headquartered clinical genomics testing company, Berry Genomics and Hong Kong and London-headquartered genetics and digital health company Prenetics announced today key management hires for the new company, Circle DNA, which will be operational for business by the end of Q2 2019. The 3 key management hires for Circle DNA are Joe Yan (CEO), Claire Wan (COO) and Candy Liu (Head of Marketing...
By Dave Muoio February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers. The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...
By Laura Lovett February 19, 2019
As the adoption of digital health continues to climb among consumers, how customers are using that technology is evolving. Instead of a narrow focus on general health and fitness, users are starting to employ digital health to manage complex conditions, according to a recent Rock Health study.  “Consumers continue to go digital and are now doing so not just out of curiosity or for general fitness...
By Laura Lovett February 18, 2019
We are living in a time when there is increasingly more data being collected, opening up more opportunities for researchers. As the industry begins to see patients become consumers, the conversation around this data has begun to include questions of ownership and compensation.  “What we really want to do is empower patients to take back full control of their data,” Nicolas Schmidt, chief product...
By Laura Lovett February 15, 2019
Getting to a doctor’s office for a diagnosis can take days if not weeks — but getting a Google "diagnosis" takes seconds. Accessing information, both accurate and inaccurate, is easy today, opening new doors for consumers of healthcare.  “We are in a world where consumers have a lot of information and we need to give them a system to figure out how do we use that information appropriately and how...
By Jonah Comstock February 14, 2019
Smartphone-connected ECG maker AliveCor has officially named an interim CEO, shortly after securing $20 million in debt funding from Oxford Finance. Ira Bahr, the new interim CEO and former chief commercial officer, told Babyforyou.net.ua that the company is gearing up for a big year in 2019. “I think we’re going to do more in the next six months than we have in the last six years,” he said. “That...
By Dave Muoio February 12, 2019
Samsung’s inroads into healthcare have taken numerous forms over the years, but often the international electronics company is happy to serve as the technological backbone of its partners’ novel health products. The company's HIMSS19 showing suggests that the coming year will be little exception, with Samsung showcasing a number of health assessment tools and provider workflow products supported...
A generic startup

Photo by Caiaimage/Chris Ryan

By Bradley Merrill Thompson February 8, 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.  In January, FDA released version 1.0 of its Working Model for the agency’s Precertification Program for Software as a Medical Device (SaMD) (i....
By Dean Koh February 7, 2019
Digital therapeutics company Kaia Health has unveiled a feasibility study to examine the impact of its digital therapeutic treatment of Chronic Obstructive Pulmonary Disease (COPD) on Japan’s ageing population. This follows a German pilot study which successfully decreased symptoms. COPD is an umbrella term to describe chronic lung diseases that cause limitations in lung airflow. According to the...
By Dave Muoio January 30, 2019
Giblib — the maker of a variety of streaming medical education videos that can be viewed the web, on mobile and in virtual reality — has launched a new app on the Oculus Store that features 360-degree VR videos of pre-recorded and live operating room procedures, the company announced yesterday. The app and its videos are available to any consumers with a subscription to Giblib’s service and an...