FDA authorises Abbott’s Libre Duo dual glucose-ketone sensor

Abbott received CE Mark approval in Europe for its Esprit BTK System, a dissolvable stent for peripheral artery disease (PAD) below the knee. The system, which delivers everolimus, is designed to open arteries and dissolve over time. Clinical data showed a 48% reduction in repeat procedures compared to balloon angioplasty. Abbott aims to improve treatment options for PAD, a condition affecting 50 million Europeans.

Abbott received CE-mark approval for its 76mm Esprit BTK system to treat chronic limb-threatening ischaemia (CLTI). The longer-length device addresses the need to treat extensive below-the-knee lesions with fewer scaffolds, reducing procedural complexity. Abbott claims it is the only dissolving resorbable scaffold with robust long-term clinical evidence. The company sees this as an advancement for physicians in Europe, offering a solution for complex CLTI cases.

The FDA approved Abbott's Libre Duo 10 Day, the first wearable device to monitor both glucose and ketones continuously. The system, for diabetes patients aged 2+, received De Novo approval after clinical trials. Abbott plans integrations with insulin pumps from Beta Bionics, Sequel Med Tech, Insulet, Tandem Diabetes, and Medtronic by 2027. ABT shares rose 0.32% to $116.30. Analysts note potential competition with DexCom.

Abbott Laboratories (ABT) received FDA authorization for its Libre Duo 10 Day system, a first-of-its-kind dual glucose ketone sensing biowearable for diabetes management. The device continuously tracks both glucose and ketone levels to address diabetic ketoacidosis risks. Abbott plans a U.S. launch, expanding its digital health and diagnostics portfolio. The company has a market cap of about $201.9 billion.

Abbott (ABT) received FDA authorization for its Libre Duo 10 Day system, the first dual glucose-ketone sensor for diabetes management. The device monitors glucose and detects rising ketones, alerting users to potential DKA emergencies. It integrates with Abbott's digital ecosystem and is compatible with leading automated insulin delivery systems. ABT plans a U.S. launch later this year. The stock traded at $115.30 in pre-market.

Abbott (NYSE: ABT) received FDA authorization for its Libre Duo 10 Day, the first dual glucose-ketone sensing technology. The biowearable monitors both glucose and ketone levels, helping detect rising ketones that can lead to diabetic ketoacidosis (DKA). Abbott plans to launch the product in the U.S. later this year, with compatibility with leading automated insulin delivery systems. The company aims to integrate the technology with multiple AID systems by the end of 2026 and 2027.