Abbott Laboratories (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Tendyne™ transcatheter mitral valve replacement (TMVR) system. This device is the first of its kind in the U.S. designed to treat mitral valve disease without the need for open-heart surgery.
Tendyne is intended for patients who cannot undergo traditional surgical valve repair or replacement. This device meets the growing demand for less invasive treatments, especially as the population ages. Abbott expects Tendyne to become an important product for its business.
The FDA approval strengthens Abbott’s position in the structural heart market, which is valued at around $15 billion worldwide. It is expected to help accelerate the company’s growth. Abbott’s Medical Devices segment already makes up 47% of the company’s total revenue as of the first quarter of 2025. This segment is the fastest growing part of Abbott’s business, with U.S. revenue rising 15% year-over-year.
This approval comes just weeks after Abbott raised its revenue growth forecast for 2025 to 7.5% to 8.5%. Analysts had previously expected a 6.4% increase. This raises the chances that Abbott could exceed market expectations, potentially boosting its stock price further. So far this year, Abbott’s shares have outperformed the broader market by 17%, showing strong momentum.
Abbott Laboratories is a global healthcare company that develops and sells technologies in diagnostics, medical devices, nutritionals, and branded generic medicines.
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