GE HealthCare Tops List for Third Year in a Row with Highest Number of AI-Enabled Medical Device Authorizations

Rhea-AI Summary

GE HealthCare has secured the top spot in the FDA's list of AI-enabled medical devices for the third consecutive year, with 72 devices authorized in the U.S. to date.

This achievement is part of the company's strategy to invest in AI and machine learning to enhance precision care, a holistic approach integrating multiple technologies for optimal patient outcomes.

Key authorized devices include Precision DL for enhanced lesion detectability, Contour ProtégéAI+ for radiation oncology, and Caption Interpretation Automated Ejection Fraction Software for cardiac evaluations. This recognition underlines GE HealthCare's commitment to leveraging advanced technologies to address industry challenges and improve healthcare delivery.

Positive

• GE HealthCare has 72 AI-enabled medical devices authorized by the FDA, more than any other company.
• Maintained top spot in FDA’s AI-enabled device authorizations list for three consecutive years.
• Company's investment in AI and machine learning aligns with its precision care strategy.
• Newly authorized devices include Precision DL, Contour ProtégéAI+, and Caption Interpretation Automated Ejection Fraction Software, indicating continuous innovation.
• Recognition underscores GE HealthCare's role in advancing healthcare technology and improving patient outcomes.

Negative

• No specific revenue data or financial impact disclosed, limiting investor insight into the financial benefits.
• Does not mention any direct financial gains or market share increase from the FDA authorizations.
• Potential for high R&D costs associated with continuous investment in AI and machine learning.

Insights

Medical Technology Analyst

GE HealthCare's position as the leader with the highest number of FDA-authorized AI-enabled medical devices is significant for multiple reasons. First, this achievement underscores the company's commitment to innovation in healthcare technology. AI in medical devices can significantly improve diagnostic accuracy, treatment planning and overall patient care, important for addressing modern healthcare challenges. For instance, AI applications like the Contour ProtégéAI+ in radiation oncology treatment planning can reduce errors and speed up the process, directly influencing patient outcomes. Second, the breadth of GE's AI-enabled solutions, from high-resolution imaging systems to automated cardiac measurements, positions the company as a versatile player in the medical tech industry. Third, consistent leadership in FDA authorizations signals trust and reliability in GE's products, influencing purchasing decisions by hospitals and clinics.

For retail investors, continuing dominance in FDA authorizations could translate into strong financial performance, as healthcare providers increasingly adopt AI-enabled technologies to enhance patient care and operational efficiencies. However, it's essential to monitor how these innovations translate into market adoption and revenue growth over time.

Financial Analyst

From a financial perspective, GE HealthCare's leadership in FDA AI-enabled device authorizations is a promising indicator of sustained growth and competitive advantage. Being at the forefront of AI in the medical device sector not only enhances GE's product portfolio but also strengthens its market position. The healthcare sector is increasingly leaning towards AI solutions for operational efficiency and precision care, which could result in higher sales and long-term recurring revenue from service contracts and software updates. The integration of AI into GE HealthCare’s existing products can also create new revenue streams and enhance profit margins.

Investors should observe the company's quarterly financial reports for tangible impacts on revenue growth from these AI-enabled devices. Moreover, the recent acquisitions of companies like Caption Health and BK Medical will be worth watching to see how well these integrations pay off financially. Considering the market appetite for AI solutions in healthcare, GE HealthCare's focus on AI aligns well with current industry trends, potentially making it a more attractive stock in the long term.

Market Research Analyst

Analyzing the market implications, GE HealthCare setting a benchmark with 72 FDA-authorized AI-enabled medical devices highlights a trend towards adopting advanced technologies in the healthcare landscape. This not only sets a high standard for competitors but also asserts GE's authority in the AI medical device space. The widespread acceptance and approval of these devices by the FDA enhance GE's reputation and can lead to market share expansion as healthcare providers seek trusted and effective AI solutions.

Additionally, by addressing critical issues such as physician burnout and data overload through AI, GE HealthCare is tapping into pressing needs within the healthcare sector. As the industry moves towards precision medicine and personalized care, the integration of AI can drive significant changes. This positions GE HealthCare favorably in terms of future market opportunities, particularly in segments like diagnostics and treatment planning, where AI can offer substantial improvements.

For retail investors, this development suggests GE HealthCare's strategic focus is not only in line with current market needs but also future-proof, potentially offering sustainable growth prospects.

• FDA’s list of AI-enabled device authorizations includes more than 850 devices; 72 are from GE HealthCare – more than any other medical technology company

CHICAGO--(BUSINESS WIRE)-- GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI) enabled medical devices for the third year in a row with 72 listed 510(k) clearances or authorizations to date in the United States. GE HealthCare also topped the list when it was updated by the FDA in 2022 and 2023.

Central to the company’s strategy, GE HealthCare is investing in AI and machine learning to power its vision of enabling precision care. Precision care is a holistic approach that integrates multiple technologies (e.g., advanced medical imaging, AI, and molecular diagnostics) to tailor diagnosis, treatment, and ongoing monitoring and management for optimal patient outcomes. Through this approach, the company is tackling the industry’s toughest challenges including data overload, physician burnout, and real-time operational efficiency by developing purpose-built solutions powered by AI that enable practitioners to deliver high-quality, precision care.

“GE HealthCare is committed to pushing the boundaries of what is possible, utilizing advanced technologies like AI, to help deliver the future of healthcare. We are leveraging our deep industry expertise, and the unique capabilities honed through offering leading medical devices for more than 125 years to create solutions that solve our customers’ biggest challenges. GE HealthCare’s continued leadership in AI-based medical device authorizations shows our dedication to deliver ground-breaking technology that transforms healthcare and enhances patient outcomes,” said Dr. Taha Kass-Hout, Chief Science and Technology Officer at GE HealthCare.

The FDA’s webpage, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, provides a list of authorized devices, granted through 510(k) clearances, De Novo requests, or by premarket approval (PMA). Included in the list are 72 GE HealthCare 510(k) clearances or authorizations, including those from recently acquired companies, BK Medical, Caption Health and MIM Software. Examples include:

• Precision DL is our innovative deep learning-based image processing software that is engineered to provide increased small, low-contrast lesion detectability compared to our conventional Time-of-Flight PET/CT scanner¹.
• Contour ProtégéAI+ (MIM Software) automatically generates contours for radiation oncology treatment planning, which helps reduce simulation to treatment times. Editing can be performed, if necessary, by the Dosimetrist or Physicist.
• Caption Interpretation Automated Ejection Fraction Software (Caption Health) is used to process previously acquired transthoracic cardiac ultrasound images, store the images, manipulate them, and make measurements on images using an ultrasound device, personal computer, or a compatible DICOMcompliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
• bkActiv (BK Medical) provides high-resolution images with superb anatomical details for visualization of structures and performing confident surgical procedures and includes Prostate Volume Assist (PVA), an AI software feature to automate the manual process for generating prostate volume measurements. PVA is also available on the bk3000/5000 and bkSpecto active imaging systems.

For more information about GE Healthcare’s AI-enabled medical device and enterprise digital solutions, visit here.

¹ At matched scan time and injected dose. Detectability using clinical data with an inserted 8 mm diameter liver lesion of known location and 2:1 contrast using a CHO model observer, comparing SNR from Omni Legend 32 cm with QCHD and Precision DL to SNR from Discovery™ MI 25 cm with QCFX.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X (formerly Twitter), Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240522128194/en/

Linh Dinh

Global Communications Director, Science & Technology

M 408.275.5682

Linh.Dinh@gehealthcare.com

Source: GE HealthCare

FAQ

How many AI-enabled medical devices has GE HealthCare received FDA authorization for?

GE HealthCare has received FDA authorization for 72 AI-enabled medical devices.

What are some examples of GE HealthCare's AI-enabled medical devices?

Examples include Precision DL for enhanced lesion detectability, Contour ProtégéAI+ for radiation oncology, and Caption Interpretation Automated Ejection Fraction Software for cardiac evaluations.

How long has GE HealthCare topped the FDA's list of AI-enabled medical devices?

GE HealthCare has topped the FDA's list for three consecutive years.

What is GE HealthCare's strategy behind its AI-enabled medical devices?

GE HealthCare's strategy involves investing in AI and machine learning to enhance precision care, which integrates multiple technologies for optimal patient outcomes.

What impact does GE HealthCare's FDA authorizations have on the company?

The FDA authorizations highlight GE HealthCare's leadership in AI-enabled medical devices, but the press release does not detail specific financial impacts.