Site icon pharmaceutical daily

GE HealthCare Tops List with Highest Number of AI-Enabled Medical Device Authorizations, Developing Innovative Solutions for Precision Care

CHICAGO–(BUSINESS WIRE)–GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI) enabled medical devices with 58 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.

AI is central to the company’s digital strategy, which is focused on its precision care framework that includes smart devices, targeted therapies, a disease-specific focus, and digital solutions. Precision care can bring data together in the right place at the right time, solving for inefficiencies in the clinical care workflow and improving patient care quality across the care pathway. GE HealthCare is working to unlock the full potential of AI to help customers leverage data across health care systems, solve operational and diagnosis challenges and develop personalized approaches for better patient outcomes.

“We are still in the nascent stages of AI development, and its potential to redefine healthcare is immense. From bedside predictions, patient monitoring, early diagnosis, to guided screening, AI’s potential for contributions to customization, precision, cost-saving, access, and health equity is unparalleled. GE HealthCare’s continued leadership in AI-based medical device authorizations underscores our dedication to deliver ground-breaking technology. Our goal is to transform healthcare and enhance patient outcomes,” said Dr. Taha Kass-Hout, Chief 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 58 GE HealthCare 510(k) clearances or authorizations, including those from recently acquired companies, BK Medical and Caption Health. Examples include:

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

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 100 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 an $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits.

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

1 Sonic DL™ vs fully sampled cardiac CINE acquisition.

2 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.

Contacts

Media Contact:
Linh Dinh

Global Communications Director, Science & Technology

M 408.275.5682

Linh.Dinh@gehealthcare.com

Exit mobile version