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Abbott (ABT) Receives FDA Approval for OCT Imaging Platform

Abbott Laboratories ABT recently received the FDA go-ahead for its latest optical coherence tomography (OCT) imaging platform, powered by the company's new Ultreon Software. The Ultreon Software is a first-of-its-kind imaging software that combines OCT with artificial intelligence (AI). It offers physicians an enhanced and comprehensive view of coronary blood flow and blockages to assist in physicians’ decision-making and provide the best treatment course for patients.

The United States’ clearance for the OCT imaging platform closely follows the attainment of CE Mark for the same in Europe. The recent regulatory authorizations provide interventional cardiologists with broader access to the latest OCT imaging platform. Per Abbott’s annual study titled Beyond Intervention, 83.2% of physicians are in agreement that advances in diagnostic and treatment technologies, such as OCT, have led to tangible improvements in patient care.

The FDA approval for Abbott’s OCT imaging platform is expected to bolster the company’s vascular business. The launch of Ultreon Software for OCT in the United States demonstrates the company’s commitment toward continual innovation in the global vascular community.

More About the Ultreon Software

At present, as cardiologists continue to adopt OCT over traditional imaging methods, such as angiography, emerging technologies are pivotal to determine the best course of patient care. In this regard, AI allows Ultreon Software to automatically detect calcium and vessel diameters, thereby guiding doctors to place stents with precision.

The Ultreon Software integrates with Abbott's new Dragonfly OpStar imaging catheter and PressureWire X guidewire to provide physicians access to a broad set of tools to evaluate coronary blood flow and blockages to help improve treatment planning for patients.  

Industry Prospects

Per a report published in Medgadget, the cardiac imaging software market is anticipated to witness a CAGR of 6.9% during 2019-2027. Factors such as increasing prevalence of cardiovascular diseases, growing incidence of hypertension and hereditary factors, rising cases of cardiac arrests in pediatric population, surge in geriatric population, and technological innovations are expected to fuel market growth.

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Given the market prospects, the recent attainment of FDA approval for Abbott’s OCT imaging platform bears strategic significance.

Notable Developments

In August 2021, Abbott received FDA go-ahead for its FreeStyleLibre 2 iOS application. This application is compatible for use with iPhones and provides a comprehensive digital offering for its FreeStyleLibre 2-integrated continuous glucose monitoring system. The application enables users, particularly adults and children (four and older) with diabetes, to receive glucose readings directly on their iPhones. It also enables users to share their glucose data with their caregivers through the LibreLinkUp application.

In July 2021, the company announced the launch of Jot Dx in the United States. The Jot Dx is Abbott’s latest insertable cardiac monitor which enables clinicians and hospitals to control the amount of electronic data received for irregular heart rhythms. The Jot Dx permits remote detection and improved diagnosis accuracy of cardiac arrythmia in patients.

In the same month, Abbott announced the receipt of FDA approval for its XIENCE family of stents for one-month (as short as 28 days) dual anti-platelet therapy ("DAPT") labeling for patients at high bleeding risk (HBR). The XIENCE stents also received the CE Mark approval for DAPT for 28 days. Further, Abbott announced the receipt of FDA and CE Mark authorizations for its next-generation XIENCE Skypoint stent.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 22.2% compared with the industry’s 12.5% growth.

Zacks Rank and Key Picks

Currently, Abbott carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the Medical-Products industry include Envista Holdings Corporation NVST, ResMed Inc. RMD and BellRing Brands, Inc. BRBR.

ResMed, sporting a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 13.9%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Envista Holdings, sporting a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.8%.

BellRing Brands, carrying a Zacks Rank #2, has a long-term earnings growth rate of 25.3%.


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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