GE HealthCare Tops List for Third Year in a Row with Highest Number of AI-Enabled Medical Device Authorizations
May 22 2024 - 9:00AM
Business Wire
- 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
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.
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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
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