The company has now accumulated over 100 authorizations for artificial intelligence in its medical technology portfolio.
GE HealthCare has surpassed 100 510(k) clearances and authorizations from the US Food and Drug Administration (FDA) for its artificial intelligence-enabled medical devices. According to the company, this marks the fourth year in a row it has held the highest number of AI-related FDA clearances.
The milestone reflects an investment in research and development, with smart devices, software, and cloud-based solutions central to GE HealthCare’s care strategy. The momentum demonstrates GE HealthCare’s progress toward achieving its goal of securing more than 200 authorizations.
“Our sustained leadership in AI-enabled medical devices reflects our commitment to research and development, which is powering the creation of next-generation solutions. These solutions are designed to address the toughest challenges our customers are facing including care team shortages and burnout, rising costs, and inefficient workflows,” says Dr Taha Kass-Hout, GE HealthCare’s global chief science and technology officer, in a release. ”
AI Integration Across Modalities
The FDA’s webpage, Artificial Intelligence-Enabled Medical Devices, provides a list of device authorizations, granted through 510(k) clearances, De Novo requests, or by premarket approval. GE HealthCare’s 100 authorizations to date demonstrate innovation across imaging modalities and care pathways including oncology, cardiology, and neurology.
Examples of GE HealthCare’s AI solutions include:
• AI-based auto positioning uses deep learning to automatically detect anatomical landmarks, which are used to determine the patient’s orientation inside computed tomography (CT) and positron emission tomography (PET)/CT devices, including Revolution Apex platform and Omni Legend.
• AIR Recon DL is a deep learning algorithm for image reconstruction that is designed to enable radiologists to achieve pin-sharp images quicker.
• The LOGIQ Series ultrasound portfolio of systems allows clinicians to scan, diagnose, and treat a wide range of patients and conditions. With AI-powered automation, real-time workflow enhancements, and strong image quality, the LOGIQ Series is designed to facilitate faster, more efficient scanning and support diagnostic precision.
• Precision DL is deep learning-based image processing, available on the Omni Legend PET/CT system, that enhances image quality in PET/CT scans.
• Venue Family point-of-care ultrasound systems with AI-powered Caption Guidance software provides real-time, step-by-step guidance to help even new ultrasound users capture cardiac views and diagnostic-quality images.
“We’re accelerating the pace of innovation to meet the urgency of today’s healthcare challenges. Reaching this milestone is also an important step along our journey of evolving from an imaging company to a healthcare solutions provider, enabling us to deliver holistic and integrated solutions that meet our customers’ needs today and will help enable them to stay ahead in a rapidly evolving healthcare environment,” says Kass-Hout in a release.
ID 163033177 | Medical © Pop Nukoonrat | Dreamstime.com
