Abbott Laboratories reports developments across a global healthcare portfolio that includes diagnostics, medical devices, nutritionals and branded generic medicines. Recurring updates cover cardiovascular technologies such as Ultreon coronary imaging, pulsed field ablation and cardiac pacing systems; diabetes and other medical devices; nutritional products; and diagnostic testing.
Abbott news also includes financial results, guidance, product clearances, clinical data presentations, commercial integrations and portfolio changes. Following the completed Exact Sciences acquisition, oncology diagnostics are a recurring theme, including Cologuard, Oncotype DX, Oncodetect, Riskguard and Cancerguard tests for cancer screening, recurrence risk and treatment support.
Abbott's FreeStyle Libre 3 system achieves a mean absolute relative difference (MARD) of 7.9%, becoming the first 14-day continuous glucose monitor (CGM) to fall below an 8% threshold. This breakthrough was presented at the American Diabetes Association's 82nd Scientific Sessions on June 5, 2022. The system aids healthcare providers in making earlier treatment decisions while significantly enhancing diabetes management accuracy and confidence.
Abbott is developing a groundbreaking biowearable device to monitor glucose and ketone levels simultaneously, targeting individuals with diabetes and the risk of diabetic ketoacidosis (DKA). The device has received breakthrough device designation from the FDA, expediting its review. With studies showing that continuous ketone monitoring could prevent DKA, the product aims to enhance diabetes management. Clinical trials are set for 2023, and Abbott plans to ensure interoperability with insulin pumps, leveraging its existing FreeStyle Libre technology used by 4 million globally.
Abbott has received FDA clearance for the FreeStyle Libre 3, a breakthrough 14-day continuous glucose monitoring system aimed at diabetes management for individuals aged four and older. The FreeStyle Libre 3 boasts a 7.9% mean absolute relative difference (MARD), making it the most accurate CGM on the market, and is priced comparably to earlier versions to enhance affordability. With smartphone integration and a small, discreet design, it aims to address the needs of over 133 million diabetes patients in the U.S. The product will be available later this year through participating pharmacies.
Diandra Debrosse Zimmermann has made legal history as the first black woman appointed co-lead counsel in a massive products liability case against Abbott Laboratories (NYSE: ABT) and Mead Johnson. This multidistrict litigation involves over 60 lawsuits claiming that formulas like Similac, used for premature infants, led to necrotizing enterocolitis (NEC). Zimmermann emphasized the need for accountability from these corporations, citing their awareness of the risks associated with their products. The case is currently in the United States District Court for the Northern District of Illinois.
On May 24, 2022, Abbott announced the release of limited quantities of EleCare® specialty formulas, aimed at addressing urgent needs for children with severe food allergies. This action comes after U.S. District Court approval to amend a consent decree following a February recall. Abbott plans to restart production at its Sturgis facility on June 4, prioritizing EleCare manufacturing, with consumer availability expected by June 20. The product release is free of charge for affected families, while additional stocks will be produced to meet ongoing demand.
Abbott (NYSE: ABT) presented significant data at EuroPCR 2022, showcasing its minimally invasive heart devices like TriClip™ and Navitor™. Findings revealed that TriClip significantly reduces tricuspid regurgitation, achieving a 98% implant success rate and 71% improvement in TR levels. Navitor's one-year results also demonstrated safety with a 97.5% procedural success rate and only 4.2% all-cause mortality. These outcomes emphasize Abbott's commitment to enhancing patient quality of life through innovative heart solutions.
Abbott has agreed to a consent decree with the FDA regarding its Sturgis, Michigan infant formula plant, enabling a path to resume production. Following FDA approval, Abbott could restart operations within two weeks, leading to product availability on shelves in 6-8 weeks. The CDC found no link between Abbott's products and infant illnesses, and the company continues to import formula from Ireland to address supply shortages. Abbott maintains its full-year 2022 earnings guidance of at least $4.70 per share despite incurring unspecified one-time charges related to the decree.
Abbott (NYSE: ABT) has partnered with Women as One to launch the CLIMB Research program, aimed at training underrepresented physicians in clinical trials. The program will provide six monthly sessions focused on skill development, networking, and knowledge enhancement for diverse cardiologists, including women and minorities. Abbott has invested $150,000 in this initiative, furthering its commitment to diversity in clinical research. This partnership is part of Abbott's broader strategy to increase representation in clinical trials and improve health outcomes in under-resourced communities.
Abbott has received FDA clearance for its Alinity™ m STI Assay, a multiplex test capable of detecting four sexually transmitted infections (STIs) simultaneously: Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma. The test addresses rising STI rates exacerbated by pandemic-related disruptions in routine testing. Utilizing the advanced Alinity m system, this test enhances efficiency in diagnosis and treatment for healthcare providers. Abbott aims to improve accessibility to STI testing, reflecting on the changes in healthcare delivery during the pandemic.
Abbott (NYSE: ABT) is releasing limited quantities of metabolic nutrition formulas at the U.S. FDA's request, following a recall of some infant formulas. The released products were not part of the February recall and have met safety standards. Patients can obtain these formulas through healthcare providers and referrals. Abbott's Sturgis facility remains under scrutiny, but no link has been found between it and reported infant illnesses. The company is working with the FDA to resume operations, with new production expected in six to eight weeks.