CAESAREA, Israel – DarioHealth has received the Therapeutic Goods Administration Mark for an iPhone version of its Dario Blood Glucose Monitoring System in Australia. “We are thrilled that DarioHealth secured TGA approval to offer the Lightning-enabled version and can now accommodate users in Australia who have updated their Apple devices,” said Erez Raphael, CEO and chairman of DarioHealth, in a statement. “We hope to help the 1.7 million Australians who have diabetes, specifically the more than 100,000 Australians who have been diagnosed with diabetes in the past year.” In addition to the TGA approval, users in the U.K. are now able to purchase the Lightning-enabled Dario device, as well. DarioHealth is still waiting on approval from regulatory agencies in the U.S. and Canada, which is expected in the coming months.
SILVER SPRING, Md. – Dr. Scott Gottlieb, commissioner of the U.S. Food & Drug Administration, recently revealed the agency’s plans to establish a more efficient approach to digital health device regulation—and industry experts are cautiously optimistic.
“The streamlined certification process is a step in the right direction,” said Xu Zou, CEO of Internet of Things security software provider ZingBox.
Gottlieb’s Digital Health Innovation Plan calls for the government to establish public health policies that are clear enough for developers to apply on their own, without having to seek out the FDA’s position on every technology change or software development on a case-by-case basis.
“Smart devices make streamlining the FDA’s approval process a necessity,” said Jacques Touillon, CEO and co-founder of Airboxlab, maker of smart air quality monitoring devices.
“The current system worked when changing the function of a device meant shipping a whole new product, but today developers can add entirely new features to a product as it sits on a user’s nightstand, simply by updating the software over the Internet,” he said.
In his blog post that laid out the new plans, Gottlieb said the FDA will establish guidelines specifying the boundaries around low-risk technologies like some mobile health apps and clinical administrative support software. In addition, the agency will add other technologies that could be considered low-risk.
The commissioner also described a new third-party certification pilot program, still under development, under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA premarket review.
Zou said that while the FDA’s plans may help streamline the certification process, device security must be a top priority.
“History has shown that where new features and innovation go, so do the hackers and malware,” he said. “As the requirements of FDA certification relaxes, device manufacturers and health care providers must plan for the additional security needed to protect the more feature-rich devices.”
During a recent interview with reporter Dan Gorenstein of Marketplace, I shared with him that the U.S. Food & Drug Administration approved 15,000 medical devices from 2012-2016, with over 2,900 medical devices approved in 2016 alone (according to EmergoGroup). In researching that statistic, I learned some other fun facts about the FDA approval process.
Did you know that the average medical device approval from the FDA takes an average of 177 days? Neither did I.
Did you know that all 510(K) submissions are assigned a “K number” – the letter K followed by six digits? The first two digits of the 510(K) number indicate the year it was submitted for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year.
Did you know that the first 510(K) ever submitted was by Zimmer Inc., which holds K760001, submitted on May 26, 1976.
Did you know that Boston Scientific Scimed Inc. owns K000001? It’s not the first 510(K) ever, but it was the first one submitted in the new millennium on January 3, 2000.
I’m sure 2017 will see it’s share of medical device approval submissions to the FDA and I’m sure we’re going to learn about some incredible technologies to help improve the way home health care is delivered. I’ll try to cover most of it right here, so stay tuned!
Thanks to medical device consultants EmergoGroup for the FDA fun facts.
MONTREAL – Tactio Health Group has registered its TactioRPM telehealth platform at both the Brazilian Health Regulatory Agency (ANVISA) and French National Agency for Medicine and Health Products Safety (ANSM) for CE Mark Class I. This follows TactioRPM’s registration at the U.S. Food and Drug Administration in 2015. TactioRPM is an app-enabled platform that combines mobile apps, hundreds of connected health integrations, patient questionnaires, digital coaching programs and HIPAA-compliant messaging. Powering telehealth initiatives from payers, providers and pharma, its range of clinical applications include chronic disease monitoring, population health screening, clinical research and post-acute care.