FDA Approves Abbott's First Wearable Device for Dual Ketone and Glucose Tracking
I'm LongbridgeAI, I can summarize articles.The FDA approved Abbott's Libre Duo 10 Day, the first wearable device in the U.S. to continuously monitor both glucose and ketones for diabetes patients aged two and older. Authorized via the De Novo pathway based on six clinical studies with over 600 participants, the sensor alerts users to rising ketone levels. Abbott plans integrations with insulin pumps from Beta Bionics, Sequel Med Tech, Insulet, Tandem Diabetes Care, and MiniMed Group by late this year and 2027. Analysts view the clearance as competitive, particularly for pediatric use, potentially impacting rivals like DexCom.
The U.S. Food and Drug Administration (FDA) on Tuesday approved Abbott Laboratories’ (NYSE:ABT) Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for diabetes patients aged two and older.
The regulatory nod makes the device the first wearable in the U.S. to monitor ketone levels continuously. It also represents the first global system to track blood sugar and ketones simultaneously within a single unit.
Clinical Data And De Novo Pathway
The agency granted marketing authorization to Abbott via the De Novo pathway, which applies to new, low-to-moderate-risk medical devices.
The sensors alert users when ketones rise, replacing single-point urine or blood tests with continuous tracking.
Read Also: Abbott Bypasses Appeals Process To Settle Ongoing Premature Infant Formula Litigation
This authorization followed a comprehensive review of six clinical studies involving over 600 participants. Trial results demonstrated the sensor accurately tracks clinically significant ketone variations.
Libre Duo 10 Day offers up to 10 days of wear.
Future Integrations With Insulin Pumps
The manufacturer actively works with leading pump companies to connect the sensors with automated insulin delivery systems.
The company expects the Libre Duo 10 Day to sync with iLet from Beta Bionics Inc (NASDAQ:BBNX) and twiist from Sequel Med Tech by the end of this year.
Looking ahead to 2027, the dual monitor will integrate with systems from Insulet Corp (NASDAQ:PODD) and Tandem Diabetes Care Inc. (NASDAQ:TNDM). Additionally, the company is collaborating with MiniMed Group Inc. (NASDAQ:MMED) on an exclusive integration for smart dosing systems expected the same year.
William Blair on Wednesday wrote, “Our initial impression of Abbott’s U.S. Libre Duo 10-day sensor clearance is that this sensor will likely be most competitive in the pediatric population once integrated with AID pumps into next year.
Analyst Brandon Vazquez also notes that the update may linger on DexCom Inc. (NASDAQ:DXCM) shares as it creates a new competitive dynamic.
ABT Price Action: Abbott Laboratories shares were trading higher by 0.32% to $116.30 at the time of publication on Wednesday, according to Benzinga Pro data.
Read Also: Bitcoin Stuck Below $80,000 as Ethereum Funding Rates Hit 1-Year High
Photo: Shutterstock