Automated insulin delivery system for diabetes management gets FDA approval

fda clears artificial pancreas medtronic minimed 670g hybrid closed loop
There is momentous news for Type 1 diabetics. On Wednesday, the U.S. Food and Drug Administration (FDA) approved the first Hybrid Closed Loop insulin delivery system in the world, according to Medtronic and the Juvenile Diabetes Research Foundation (JDRF).

The Medtronic MiniMed 670G system is a wearable device that combines continuous blood-glucose monitoring — blood-sugar testing — with an insulin pump. The algorithm used to adjust insulin dosing, called SmartGuard HCL, was the last step in Medtronic’s phased development of the closed-loop system.

According to Richard M. Bergenstal, M.D., principal investigator of the study and executive director of the Park Nicollet International Diabetes Center in Minneapolis, “The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community.”

The JDRF is enthusiastic as well. “This significant milestone represents an important step forward in the management of Type 1 diabetes and will improve the quality of life for those living with this chronic disease,” said Derek Rapp, JDRF president and CEO. “We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough. Medtronic and JDRF are committed to ensuring appropriate patient access to this therapy.”

The MiniMed 670G system includes Medtronic’s Guardian Sensor glucose monitor, which has a seven-day battery life. In addition to monitoring glucose levels, the Guardian also self-monitors the sensor — if patients rely on the sensor, any breakdown could be fatal, so self-diagnostics are vital. This is the first and so far only sensor approved by the FDA for closed-loop systems. The SmartGuard HCL algorithm has the capability to learn the patient’s insulin needs to be sure glucose levels stay within the optimal target range. The only actions required by patients are to input mealtime carbohydrate intake and periodically calibrate the sensor. No more multiple fingersticks, measurements, and self-administered insulin shots.

Commercial release and availability of the MiniMed 670G are expected in the spring of 2017 and regulatory approval in other countries is expected that summer.

Wearables

Lack of regulation means wearables aren’t held accountable for health claims

As fitness trackers become more like health monitors, some physicians are concerned they can lead to over-diagnosis of non-existent problems. It’s already happening with wearable baby monitors.
Mobile

Android vs. iOS: Which smartphone platform is the best?

If you’re trying to choose a new phone and you’re not sure about the merits and pitfalls of the leading smartphone operating systems, then come on in for a detailed breakdown as we pit Android vs. iOS in various categories.
Wearables

Omron HeartGuide brings blood pressure monitoring to your wrist

High blood pressure leads to heart attacks, strokes, and many other health problems, so it's important to keep an eye on. Omron's HeartGuide is a fitness tracking watch that can also monitor your blood pressure from your wrist.
Computing

Chip off the auction block – Intel’s i9-9990XE may be sold to the highest bidder

Intel's alleged Core i9-9990XE may only be sold at auction to OEMs, meaning that only a few of the 14-core, 28-thread, 5GHz CPUs will ever see the light of day in specific devices and systems.
Emerging Tech

Stomach implant device uses jolts of electricity to fight obesity

An implant created at the University of Wisconsin-Madison could help fight obesity by attaching to users' stomachs and then suppressing feelings of hunger using jolts of electricity.
Product Review

Garmin’s 4G LTE VivoActive 3 keeps you safe when you’re out on the trails

Garmin takes its already great VivoActive 3 Music fitness smartwatch and adds a 4G LTE connection, courtesy of Verizon. The watch now has streaming music, independent GPS, and best of all, SMS support and various safety features. We’ve…
Product Review

One breath into this device could change what you eat forever

Anyone living with a food intolerance knows the pain — literally and figuratively — of dealing with it, and even identifying what the cause of the problem is. The FoodMarble Aire wants to solve this, and we took a closer look at CES…
Deals

Before buying a Fitbit or Apple Watch, check out these fitness trackers under $50

Fitbit and Apple Watch are top of the line when it comes to fitness trackers but if you want to save, we have alternatives. If 2019 is the year you keep track of your health and budget your expenses, then take a look at these fitness…
Deals

Start your fitness journey with the best Fitbit deals available now

If you're ready to kick-start your fitness regimen (or just take your current one to the next level), we've created a quick rundown of the best, most current Fitbit deals to help you decide which one is best for you.
Health & Fitness

Futuristic mask filters out air pollution for cyclists and runners

A concern for cyclists in urban environments is staying safe from airborne pollutants. A cycling mask shown off at CES 2019 could help combat this problem by blocking out air pollution to keep cyclists' lungs clear as they ride.
Emerging Tech

Face-scanning A.I. can help doctors spot unusual genetic disorders

Facial recognition can unlock your phone. Could it also be used to identify whether a person has a rare genetic disorder, based on their facial features? New research suggests it can.
Deals

Walmart slashes prices on the Fitbit Versa smartwatch and Charge 3

We are officially halfway through January, and for a lot of us, that means the struggle to stick to our New Year's resolutions is in full force. Walmart is offering some great discounts on Fitbits to help you stay on track.
Outdoors

Nike’s Adapt BB shoes let you tighten your laces with an iPhone

The new Nike Adapt BB shoe comes with smartphone connectivity that allows the user to tighten the laces using a smartphone while providing the ability to adjust tension throughout the game.