Technology | Artificial Intelligence | June 19, 2019

Third FDA Clearance Announced for Zebra-Med's AI Solution for Brain Bleed Alerts

Health providers subscribed to the "all-in-one" AI1 package can now benefit from an additional alert for intracranial hemorrhage

Third FDA Clearance Announced for Zebra-Med's AI Solution for Brain Bleed Alerts

June 19, 2019 — Zebra Medical Vision announced it has received its third U.S. Food and Drug Administration (FDA) 510(k) clearance for the company's HealthICH product. The new clearance covers an artificial intelligence (AI) alert for intracranial hemorrhage (ICH), based on head computed tomography (CT) scans.

The latest cleared product automatically identifies suspected internal brain bleeds based on non-contrast head CTs for triaging, significantly reduces turnaround time and increases the radiologists' confidence in their diagnosis. The overall Multi-Modality AI Triage Solution by Zebra-med is a first of its kind in the market, according to the company, that provide alerts for both CT scans and X-rays. It currently addresses two acute conditions: intracranial hemorrhages (head CTs) and pneumothorax (chest X-rays), which also received FDA clearance in the past month. Both triage solutions and others, such as the FDA-cleared calcium scoring product, are part of the AI1 "all-in-one" bundle that provides hospitals with a growing amount of AI tools at a fixed annual price and consistent service and support.

Intracranial hemorrhage accounts for about 10-20 percent of all strokes, and can occur as a result of traumatic injury (falls, crashes, etc), ruptured arteries (aneurysms), stroke or cancer. It can result from injury within a vein or artery, or a combination of the two. Regardless of the cause, the timely and accurate diagnosis of active bleeding is essential for the successful care of these patients. Intracranial hemorrhage — or the common phrasing, brain bleed — is a devastating disease, with a high 30-day mortality rate that ranges from 35-52 percent. It is estimated that about half of this mortality occurs within the first 24 hours, emphasizing the importance of early detection and effective treatment in the emergency department (ED).

The financial impact of early detection would be enormous given the fact that stroke cost the U.S. alone $34 billion annually, including the cost of healthcare services, medications and lost productivity. The overall incidence of spontaneous ICH worldwide is 24.6 people in every 100,000 , with approximately 40,000-67,000 cases per year in the United States.

Zebra-Med's intracranial hemorrhage triage solution can provide early detection of people who may have experienced a brain bleed. The algorithm is comprised of a tailor-made neural network architecture designed to identify intracranial hemorrhage while tackling several challenges, such as relatively small bleed sizes and common artifacts (metal, motion artifacts) seen within the brain.

In busy ED environments, teleradiology services and other healthcare organizations that integrate Zebra-Med's AI1 solution, radiologists can address these prioritized scans in a timely manner. Scans are forwarded automatically to the Zebra-Med server for analysis. The server then sends an alert of the positive cases directly to the worklist for prioritizing, thus saving physicians more than 80 percent of the time taken to reach the acute condition.

The triage of intracranial hemorrhage product is supported by Zebra-med's recent research results, “Improved Intracranial Hemorrhage Classification using Deep Multi-task Learning.”  published at the Society for Imaging Informatics in Medicine (SIIM) conference in 2018. The results demonstrated how AI-based first read can achieve markedly high levels of intracranial hemorrhage detection and classification.

Keith White, M.D., medical director of imaging services at Intermountain Healthcare stated, "We are working to improve our ability to quickly identify and respond to potentially dangerous clinical conditions through deployment of Zebra Medical Vision's intracranial hemorrhage solution"

Stanley Lu, M.D., radiologist and head of neuroradiology at Monmouth Medical Center, part of RWJBarnabas Health, stated, "We have deployed Zebra Medical Vision's triage head CT solution that alerts our department of acute cases of intracranial hemorrhage. We have found the technology to be helpful as a second layer of analysis augmenting the clinical team's detection and response time for acute cases."

This is the second FDA clearance for Zebra's Multi-Modality AI Triage Solutions, which was received in May 2019 and focused on HealthPNX, an AI alert for pneumothorax (PNX), based on chest X-rays. This enabled it to be the world's first AI chest X-ray triage product, according to Zebra Medical. The company’s first FDA clearance, received in July 2018, focuses on coronary calcium scoring, which can be an early sign for coronary artery disease (CAD).

For more information: www.zebra-med.com

Related Content

#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2 A brief article from Henry Ford Health System in Detroit, published today in Radiology, reports on the first presumptive case of COVID-19–associated acute necrotizing hemorrhagic encephalopathy.

A, Image from noncontrast head CT demonstrates symmetric hypoattenuation within the bilateral medial thalami (arrows). B, Axial CT venogram demonstrates patency of the cerebral venous vasculature, including the internal cerebral veins (arrows). C, Coronal reformat of aCT angiogram demonstrates normal appearance of the basilar artery and proximal posterior cerebral arteries. Image courtesy of the Radiological Society of North America (RSNA)

News | Coronavirus (COVID-19) | March 31, 2020
March 31, 2020 — A brief article fr
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2 The Chinese start-up company Infervision launches its AI-based solution InferRead CT Lung Covid-19 also in Europe
News | Artificial Intelligence | March 31, 2020
March 31, 2020 — Lung infections generated by the coronavirus can be detected in...
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2 Doctor in our hospital is using this intelligent system for accurate diagnosis

Doctor in our hospital is using this intelligent system for accurate diagnosis. (Photo: Business Wire)

News | Artificial Intelligence | March 31, 2020
March 31, 2020 — The Intelligent Evalua...
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2 behold.ai has developed the artificial intelligence-based red dot algorithm which can identify within 30 seconds abnormalities in chest X-rays. Wellbeing Software operates Cris, a widely used UK radiology Information System (RIS), which is installed in over 700 locations
News | Artificial Intelligence | March 31, 2020
March 31, 2020 — Two British companies at the leading edge of medical imaging technology are working together on a pl
AI tool predicts which patients newly infected with COVID-19 will eventually develop severe respiratory disease #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Artificial Intelligence | March 31, 2020
March 31, 2020 — An artificial intelligence tool accurately predicted which patients newly infected with the...
A physician working in a coronavirus care center nearby Daegu, South Korea, is using Lunit INSIGHT CXR to interpret chest X-ray image of a coronavirus patient. #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2

A physician working in a coronavirus care center nearby Daegu, South Korea, is using Lunit INSIGHT CXR to interpret chest X-ray image of a coronavirus patient. Photo by Seoul National University Hospital

News | Artificial Intelligence | March 30, 2020
March 30, 2020 — Lunit, a medical AI software company that dev
In the light of the coronavirus outbreak, MILabs has enhanced its line of high-performance CT scanners to even better detect the disease #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Computed Tomography (CT) | March 27, 2020
March 27, 2020 — Based on recent scientific research, diagnostic X-ray...
CoronaCare is designed to help healthcare providers track COVID-19 (coronavirus) related symptoms of potentially infected patients. The platform enables communication with patients outside of facility walls and the ability to request the return of high-risk patients for more in-depth care. #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Coronavirus (COVID-19) | March 27, 2020
March 27, 2020 — PaxeraHealth has spent years building and be
AI vendor Infervision's InferRead CT Pneumonia software uses artificial intelligence-assisted diagnosis to improve the overall efficiency of the radiology department. It is being developed in China as a high sensitivity detection aid for novel coronavirus pneumonia (COVID-19). #COVID19 #coronavirus #SARScov2

AI vendor Infervision's InferRead CT Pneumonia software uses artificial intelligence-assisted diagnosis to improve the overall efficiency of the radiology department. It is being developed in China as a high sensitivity detection aid for novel coronavirus pneumonia (COVID-19).

Feature | Coronavirus (COVID-19) | March 27, 2020 | Jilian Liu, M.D., HIMSS Greater China
An older couple walked into the Hubei Provincial Hospital of Integrated Chinese and Western Medicine near their neigh