Abbott receives FDA clearance, CE Mark for AI imaging platform

INVESTING.COMApr 28, 1:13 PM UTC

Key insights

  • Abbott received FDA clearance and CE Mark for its Ultreon 3.0 AI-powered coronary imaging system. The platform enhances PCI procedures with real-time guidance and automated measurements. While positive for Abbott, the overall market impact on US equities is limited, representing a minor bullish signal for the healthcare sector.
Abbott receives FDA clearance, CE Mark for AI imaging platform

ABBOTT PARK, Ill. - Abbott (NYSE:ABT) received U.S. Food and Drug Administration clearance and CE Mark for its Ultreon 3.0 Software, an artificial intelligence-powered optical coherence tomography system for coronary imaging, according to a company press release issued today.

The platform uses optical coherence tomography to provide real-time guidance during percutaneous coronary intervention procedures, which are used to open blocked heart arteries. The system captures cross-sectional images of coronary arteries using infrared light-based imaging and incorporates AI to assess plaque types.

Ultreon 3.0 features a one-second OCT pullback that captures detailed arterial views with higher resolution than intravascular ultrasound. The system uses low or zero contrast, which may benefit patients with kidney disease, who represent approximately 25% of people with coronary artery disease.

The software provides automated measurements to help physicians determine stent size and placement, along with post-procedure assessment capabilities. The platform integrates imaging and AI-automated analysis in a single system.

More than 600,000 people in the U.S. and more than 885,000 in Europe undergo PCI procedures annually. Complex PCI procedures often require multiple stents to address severe coronary artery blockages.

The system builds on Abbott’s previous Ultreon 2.0 platform with enhanced AI capabilities designed for complex coronary interventions.

Abbott is a global healthcare company with 122,000 employees serving more than 160 countries. The company’s portfolio includes diagnostics, medical devices, nutritionals and branded generic medicines. With a market capitalization of $161.6 billion, Abbott stands as a prominent player in the Healthcare Equipment & Supplies industry, according to InvestingPro data.The stock currently trades at $92.80, near its 52-week low of $90.72, representing a potential opportunity for investors. InvestingPro analysis suggests the stock is undervalued compared to its Fair Value, placing it among companies on the most undervalued list. For deeper insights into Abbott’s valuation and growth prospects, investors can access the comprehensive Pro Research Report, available for ABT and 1,400+ other US equities.

In other recent news, Abbott Laboratories reported its first-quarter results, which showed a slight increase in worldwide sales by 1% compared to consensus expectations, with adjusted earnings per share aligning with forecasts. However, the company’s revenue growth was not as robust as anticipated, with Piper Sandler noting that the medical device segment, particularly the diabetes business, underperformed. This has prompted several financial firms to lower their price targets for Abbott Laboratories. Leerink Partners reduced their target to $106, while maintaining a Market Perform rating, citing mixed results in the company’s various divisions. Similarly, Bernstein SocGen Group adjusted its target to $110, maintaining an Outperform rating, after calculating a true organic growth of approximately 3.0% for the quarter. Piper Sandler and TD Cowen also revised their targets to $115, with the latter firm highlighting reduced organic guidance and weaknesses in respiratory and Libre products. RBC Capital lowered its target to $130, mentioning mixed performance across major segments, including MedTech-Diabetes and surgical products. These developments reflect the varied reactions from analysts to Abbott’s recent financial performance.

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