The FDA approves Dexcom’s continuous glucose monitoring system
The US Food and Drug Administration (FDA) has permitted the marketing of Dexcom’s G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in children aged two and older and adults with diabetes.
This is the first type of iCGM permitted to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. The data received can also be shared with five people, which will be particularly useful for parents with young children.
Such authorisation also classifies the device in class II and subjects it to special controls. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible.
“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” explained Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
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“We think G6 carriers a significant improvement in performance by building on the accuracy and reliability that patients have come to expect from Dexcom continuous glucose monitors,” added Chief Executive Kevin Sayer in a conference call with analysts, “including what we believe will be a more consistent experience across all 10 days of use while eliminating the need for routine finger prick calibrations.”
Over 30mn US citizens have diabetes, but many cases remain undiagnosed. The number of American’s over 65 which are diagnosed with diabetes, as well as new cases, are also rising, leading the health condition to remain one of the leading causes of death in the US in 2015.
Whilst CGM systems that were first marketed had a different intended use and were evaluated through the FDA’s premarket approval pathway, the most rigorous review designed for the “highest risk” class III medical devices.
However, the Dexcom G6 system is intended for a more seamless integration with other diabetes devices, and the FDA saw this as an opportunity to reduce the regulatory burden for this type of device. With the authorisation of the Dexcom G6, future iCGMs that meet special controls criteria can go through a more streamlined premarket review.
The size of a quarter, the Dexcom G6 is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid. The device transmits real-time glucose readings every five minutes to a compatible display device such as a mobile medical app on a cell phone and will trigger an alarm when a patient’s blood sugar enters a danger zone. If it’s integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump.
It does not require users to calibrate the sensor with fingerstick blood glucose measurements. In addition, it has an updated sensor probe that minimizes interference with the pain reliever acetaminophen.
Skin Analytics wins NHSX award for AI skin cancer tool
An artificial intelligence-driven tool that identifies skin cancers has received an award from NHSX, the NHS England and Department of Health and Social Care's initiative to bring technology into the UK's national health system.
NHSX has granted the Artificial Intelligence in Health and Care Award to DERM, an AI solution that can identify 11 types of skin lesion.
Developed by Skin Analytics, DERM analyses images of skin lesions using algorithms. Within primary care, Skin Analytics will be used as an additional tool to help doctors with their decision making.
In secondary care, it enables AI telehealth hubs to support dermatologists with triage, directing patients to the right next step. This will help speed up diagnosis, and patients with benign skin lesions can be identified earlier, redirecting them away from dermatology departments that are at full capacity due to the COVID-19 backlog.
Cancer Research has called the impact of the pandemic on cancer services "devastating", with a 42% drop in the number of people starting cancer treatment after screening.
DERM is already in use at University Hospitals Birmingham and Mid and South Essex Health & Care Partnership, where it has led to a significant reduction in unnecessary referrals to hospital.
Now NHSX have granted it the Phase 4 AI in Health and Care Award, making DERM available to clinicians across the country. Overall this award makes £140 million available over four years to accelerate the use of artificial intelligence technologies which meet the aims of the NHS Long Term Plan.
Dr Lucy Thomas, Consultant Dermatologist at Chelsea & Westminster Hospital, said: “Skin Analytics’ receipt of this award is great news for the NHS and dermatology departments. It will allow us to gather real-world data to demonstrate the benefits of AI on patient pathways and workforce challenges.
"Like many services, dermatology has severe backlogs due to the COVID-19 pandemic. This award couldn't have come at a better time to aid recovery and give us more time with the patients most in need of our help.”