DarioHealth introduces iPhone 8-friendly blood glucose meter
DarioHealth on Monday announced that the United States Food and Drug Administration has granted pre-market notification (510(k)) clearance for the New York-based company’s Lightning-enabled version of the Dario Blood Glucose Monitoring System.
The launch of Apple’s smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem. With today’s announcement, DarioHealth can now successfully offer to U.S. consumers its proprietary meter with either a 3.5mm headphone jack or Lightning connector.
“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance,” Erez Raphael, chairman and CEO DarioHealth, said. “We are proud that our organization worked with agility to ensure connectivity to the latest Apple devices. This is a big breakthrough to receive the FDA’s marketing clearance for the Dario product on iPhone 7, 8 and X, and allows many of our past users who upgraded to these new iPhones to renew their Dario experience. This continues DarioHealth’s U.S. market progress, and truly opens the door for wide-scale expansion in this pivotal market.”
This news opens a significant U.S. market opportunity for DarioHealth, as it enables DarioHealth to provide its diabetes management platform and expand the sales of the Dario Blood Glucose Monitoring System to iPhone 7, 8 and X SMDs.
The diabetes company has been marketing the product in the U.S. exclusively for Apple iOS 6.1 platform and higher since the FDA first granted clearance for the Dario Blood Glucose Monitoring System in December 2015, and certain leading Android SMD’s including Samsung Galaxy S series, Samsung Galaxy Note series and LG G series, since September 2017. With today’s news, DarioHealth plans to expand U.S. sales in the coming weeks.
Record-breaking influenza season nears end
For the week ended March 17, influenza activity in the United States continued to decrease, though the season is still not over, according to the latest FluView report from the Centers for Disease Control and Prevention. ILI dropped from 3.2% reported last week to 2.7%. When that illness rate metric falls below the national baseline of 2.2%, that will indicate the end of the season.
So this week may be the last week of what has been a record-breaking flu season.
However, 17 states continue to report widespread flu activity, meaning ILI activity has been reported at centers across at least half of the state, and six states still are reporting high influenza-like illness levels. Those six states are located across the continent, including Arizona and Wyoming in the West, Nebraska and South Dakota in the Midwest and South Carolina and Virginia in the South.
Nine states are experiencing moderate ILI activity.
Hospitalization rates are higher than the end-of-season hospitalization rates for 2014-2015, a high severity, H3N2-predominant season. CDC also is reporting an additional five flu-related pediatric deaths during week 11, bringing the total number of flu-related pediatric deaths this season to 133.
NIH: Advanced vaccine technology will limit future outbreaks
Scientists at the National Institute of Allergy and Infectious Diseases are working toward the development of a novel vaccine technology in an effort to improve any public health response to infectious disease threats. In a recent perspective in The Journal of the American Medical Association, the experts highlighted innovations that could significantly shorten the typical decades-long vaccine development timeline.
NIAID is part of the National Institutes of Health.
Historically, vaccines against viral diseases have used live-attenuated (weakened) viruses or inactivated whole viruses to induce protective immune responses. The development process often takes as many as 20 years or more and requires virus cultivation, animal model testing, product formulation, immunogenicity testing and years of costly clinical trials.
However, substantial technological advances of the past decade, such as synthetic vaccinology and platform manufacturing, have helped expedite the process and shorten manufacturing time, allowing clinical evaluation to begin sooner, according to the authors. Synthetic vaccinology uses information from viral gene sequencing to create DNA and mRNA molecules encoding viral proteins.
Because advancements in vaccine technology does not require replicating “live” viruses, it does not need to be done in high-level containment facilities when developing vaccines for highly pathogenic viruses.
Once a vaccine platform is established, such as that for DNA or mRNA vaccines, potentially it can be applied to multiple pathogens, especially within virus classes or families. For example, NIAID’s Vaccine Research Center quickly developed a candidate DNA vaccine for Zika virus with the same platform used previously for a related flavivirus, West Nile virus.