FDA Clears Two Abbott Glucose Monitoring Systems

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Abbott announced that it has received FDA clearance for Lingo and Libre Rio, two over-the-counter continuous glucose monitoring systems.¹ Both systems are based on Abbott’s Freestyle Libre continuous glucose monitoring technology. Libre Rio is designed to be used by adult patients with Type 2 diabetes, while, Lingo is meant for general wellness monitoring.

In a press release, Abbott’s executive vice president and group president of medical device business Lisa Earnhardt said, “There is no one-size-fits all approach for glucose monitoring, which is why we've designed different products for different people–all based on the same world-leading biowearable technology. People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes."

In the same press release, cardiologist and medical director of El Camino Health Heart and Vascular Institute said, “Continuous glucose monitors are a tool I recommend to my patients to raise their overall awareness of factors that affect their glucose and are an invaluable holistic wellness solution. Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk to developing cardiovascular disease, diabetes, Alzheimer's and certain cancers. Making continuous glucose monitors widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population."

These are just the latest FDA approvals from Abbott. In April, the company announced that it had received approval for its dissolving stent to be used in arteries below the knee.² The Esprit BTK System is designed to keep arteries open and delivery drugs to support vessel healing for patients with chronic limb-threatening ischemia.

Sahil A. Parikh, M.D., works at the Columbia University Irving Medical Center and was one of the principle investigators on the LIFE-BTK trial that was submitted to FDA. In a press release, they said, “The FDA approval of Abbott's Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide. By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy."

In the same press release, Abbott’s senior vice president of vascular business Julie Tyler said, “At Abbott, we've recognized the significant burden of disease and limited treatment options available for people living with the most severe form of PAD. That's why we're revolutionizing treatments with resorbable scaffold technology below the knee. Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives."

Also in April, Abbott announced the FDA granted clearance to a rapid blood test designed to assess whether a patient has a concussion and meant to be used at their bedside.³ The i-STAT Aliniity instrument produces lab-quality results within 15 minutes from a whole blood sample and can help doctors make assessment.

In a press release issued at the time, chief of neurosurgery at Zuckerberg San Francisco General Hospital Geoffrey Manley, M.D. and PhD, said, “Emergency departments can be a busy place. It's important to be able to triage patients quickly. Historically, that process for suspected concussions was largely subjective. With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It's an incredibly helpful tool that advances the treatment of traumatic brain injury."

Sources

1. Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems. Abbott. June 10, 2024. Accessed June 11, 2024. https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-U-S-FDA-Clearance-for-Two-New-Over-the-Counter-Continuous-Glucose-Monitoring-Systems
2. Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries Below the Knee. Abbott. April 29, 2024. Accessed June 11, 2024. https://www.prnewswire.com/news-releases/abbotts-breakthrough-dissolving-stent-receives-fda-approval-for-arteries-below-the-knee-302129457.html
3. Abbott Receives FDA Clearance for Whole Blood Rapid Test to Help with Assessment of Concussion at the Patient's Bedside. Abbott. April 1, 2024. Accessed June 11, 2024. https://www.prnewswire.com/news-releases/abbott-receives-fda-clearance-for-whole-blood-rapid-test-to-help-with-assessment-of-concussion-at-the-patients-bedside-302104458.html