AI-Based Technology for Ultrasound Image Analysis Receives FDA Approval
|
By HospiMedica International staff writers Posted on 17 Jul 2019 |
|
Image: A screenshot of the Koios DS Breast 2.0 AI-based software (Photo courtesy of Koios Medical).
Koios Medical, Inc (Chicago, IL, USA), a developer of ultrasound diagnosis decision support software, has received 510(k) clearance from the US Food and Drug Administration for Koios DS (Decision Support) Breast 2.0, a new version of its machine learning based platform that assists physicians in the classification and diagnosis of breast cancer. The software offers a proprietary alignment to BI-RADS for any lesion analyzed and is available connected to PACS and/or directly on GE Healthcare's LOGIQ E10 ultrasound system.
Koios DS (Decision Support) Breast 2.0 is intended for use to assist physicians analyzing breast ultrasound images and aligns a machine learning generated probability of malignancy with the appropriate BI-RADS category. The patented software uses an ensemble of algorithms to aid the early detection of disease while also reducing biopsies of benign tissue. Koios DS Breast 2.0 can be used in conjunction with most major PACS platforms and is directly available on the LOGIQ E10, GE Healthcare's next generation digital ultrasound system that integrates artificial intelligence, cloud connectivity, and advanced algorithms to acquire and reconstruct data. Machine generated results can be exported directly into a patient's record.
In a recent reader study involving 15 physicians with relevant experience up to 39 years, each randomly analyzed 900 cases twice, separated by a one-month "washout period." Physicians utilizing the Koios DS 2.0 AI software experienced a statistically significant improvement in accuracy as measured by area under the ROC (receiver operating characteristic) curve (AUC), while simultaneously reducing both inter and intra-operator variability.
“We are seeing the promise of machine learning as a physician's assistant coming to fruition. This will undoubtedly improve quality, outcomes, and patient experiences—and ultimately save lives,” said Koios Medical CEO Chad McClennan. “Koios DS Breast 2.0 is proving that a system trained by hundreds of thousands of images linked to their ground truth can catch many more cancers earlier, while simultaneously reducing benign biopsies and all the anxiety, complications, and associated expense. Smart ultrasound is a second set of eyes that achieves what was previously unthinkable.”
Related Links:
Koios Medical
Koios DS (Decision Support) Breast 2.0 is intended for use to assist physicians analyzing breast ultrasound images and aligns a machine learning generated probability of malignancy with the appropriate BI-RADS category. The patented software uses an ensemble of algorithms to aid the early detection of disease while also reducing biopsies of benign tissue. Koios DS Breast 2.0 can be used in conjunction with most major PACS platforms and is directly available on the LOGIQ E10, GE Healthcare's next generation digital ultrasound system that integrates artificial intelligence, cloud connectivity, and advanced algorithms to acquire and reconstruct data. Machine generated results can be exported directly into a patient's record.
In a recent reader study involving 15 physicians with relevant experience up to 39 years, each randomly analyzed 900 cases twice, separated by a one-month "washout period." Physicians utilizing the Koios DS 2.0 AI software experienced a statistically significant improvement in accuracy as measured by area under the ROC (receiver operating characteristic) curve (AUC), while simultaneously reducing both inter and intra-operator variability.
“We are seeing the promise of machine learning as a physician's assistant coming to fruition. This will undoubtedly improve quality, outcomes, and patient experiences—and ultimately save lives,” said Koios Medical CEO Chad McClennan. “Koios DS Breast 2.0 is proving that a system trained by hundreds of thousands of images linked to their ground truth can catch many more cancers earlier, while simultaneously reducing benign biopsies and all the anxiety, complications, and associated expense. Smart ultrasound is a second set of eyes that achieves what was previously unthinkable.”
Related Links:
Koios Medical
New
Gold Member
Neonatal Heel Incision Device
Tenderfoot
New
Hypodermic Syringe
SurTract™ Safety Syringe
New
Blood Pressure Monitor
Cuff Blood Pressure Monitor
Latest AI News
- Machine Learning Approach Enhances Liver Cancer Risk Stratification
- New AI Approach Monitors Brain Health Using Passive Wearable Data
- AI Tool Maps Early Risk Patterns in Bloodstream Infections
- AI Model Identifies Rare Endocrine Disorder from Hand Images
- AI Tool Promises to Reduce Length of Hospital Stays and Free Up Beds
- Machine Learning Model Cuts Canceled Liver Transplants By 60%
Channels
Artificial Intelligence
view channel
Machine Learning Approach Enhances Liver Cancer Risk Stratification
Hepatocellular carcinoma, the most common form of primary liver cancer, is often detected late despite targeted surveillance programs. Current screening guidelines emphasize patients with known cirrhosis,... Read more
New AI Approach Monitors Brain Health Using Passive Wearable Data
Brain health spans cognitive and emotional functions and can fluctuate even in adults without diagnosed disease. Detecting early changes remains difficult in routine care and burdens specialty services... Read more
Critical Care
view channel
Automated IV Labeling Solution Improves Infusion Safety and Efficiency
Medication administration in high-acuity settings is often complicated by multiple concurrent infusions, making accurate line identification essential. In a 10-hospital intensive care unit study, 60% of... Read more
First-Of-Its-Kind AI Tool Detects Pulmonary Hypertension from Standard ECGs
Pulmonary hypertension is a progressive, life‑threatening disease that is frequently missed early because symptoms such as dyspnea are nonspecific and diagnostic delays can exceed two years.... Read more
Surgical Techniques
view channel
Continuous Monitoring with Wearables Enhances Postoperative Patient Safety
Postoperative hypoxemia on general surgical wards is common and often missed by intermittent vital sign checks. Undetected low oxygen levels can delay recovery and raise the risk of complications that... Read more
New Approach Enables Customized Muscle Tissue Without Biomaterial Scaffolds
Volumetric muscle loss is a traumatic loss of skeletal muscle that often leads to permanent functional impairment and limited reconstructive options. Current experimental strategies struggle to deliver... Read more
Patient Care
view channel
Wearable Sleep Data Predict Adherence to Pulmonary Rehabilitation
Chronic obstructive pulmonary disease (COPD) is a long-term lung disorder that makes breathing difficult and often disturbs sleep, reducing energy for daily activities. Limited engagement in pulmonary... Read more
Revolutionary Automatic IV-Line Flushing Device to Enhance Infusion Care
More than 80% of in-hospital patients receive intravenous (IV) therapy. Every dose of IV medicine delivered in a small volume (<250 mL) infusion bag should be followed by subsequent flushing to ensure... Read more
Health IT
view channel
EMR-Based Tool Predicts Graft Failure After Kidney Transplant
Kidney transplantation offers patients with end-stage kidney disease longer survival and better quality of life than dialysis, yet graft failure remains a major challenge. Although a successful transplant... Read more
Printable Molecule-Selective Nanoparticles Enable Mass Production of Wearable Biosensors
The future of medicine is likely to focus on the personalization of healthcare—understanding exactly what an individual requires and delivering the appropriate combination of nutrients, metabolites, and... Read more
Business
view channel
GE HealthCare Leads Major European Initiative to Advance Cardio-Oncology Care
Cardiovascular complications are increasingly recognized among people undergoing or recovering from cancer treatment, driven by pre‑existing disease and the cardiotoxic effects of chemotherapy, radiotherapy,... Read more
