The FDA Just Gave Abbott a Diabetes First. Is Its Beaten

Abbott Laboratories (NYSE: ABT) received FDA De Novo authorization for Libre Duo, a wearable that monitors glucose and detects rising ketone levels. The company plans a U.S. launch in 2026. Abbott's stock is down 11.29% over the past year but up 9.2% over the past month. The FDA approval is a regulatory milestone but may not immediately impact revenue.

Abbott (NYSE: ABT) announced its Amulet 360 left atrial appendage occlusion device received CE Mark. The device, designed to reduce stroke risk in AFib patients, features dual-seal technology and improved conformability. A 400-patient study showed 99.8% successful implantation and 94% complete LAA closure. The device is now available in Europe and under investigation in the US.

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 (ABT) received FDA authorization for its Libre Duo 10 Day, a dual glucose-ketone sensor. The device is the first of its kind and is designed for people aged two and older. Abbott shares closed at $115.82 on 26 August, up 10.86% over 20 trading days. The company plans to launch the product in the US later in 2026, with compatibility for insulin pump systems from Beta Bionics and Sequel Med Tech. Medtronic's MiniMed unit (MMED) is also developing similar technology. Abbott reported $11.16bn

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.