- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA Clears AI Advance for Detecting Intracranial Hemorrhage on Non-Contrast CT
The AI-powered Heuron ICH software reportedly has an 86 percent sensitivity rate for diagnosing intracranial hemorrhage on computed tomography (CT) scans.
The Food and Drug Administration (FDA) has granted 510(k) clearance for Heuron ICH, an artificial intelligence (AI)-enabled software that may facilitate timely detection and triage of intracranial hemorrhages.
Through interpretation of non-contrast computed tomography (CT) scans, Heuron ICH offers an 86 percent sensitivity rate and an 88 percent specificity rate for intracranial hemorrhage, according to Heuron, the developer of Heuron ICH.
For diagnosing intracranial hemorrhages on non-contrast CT, the newly FDA-cleared Heuron ICH offers an 86 percent sensitivity rate and an 88 percent specificity rate. (Images courtesy of Adobe Stock.)
Heuron maintained that Heuron ICH facilitates rapid detection of intracranial hemorrhages and can diagnose minute hemorrhages that may evade radiologist detection.
The company noted that Heuron ICH is Heuron’s fifth AI software to garner FDA clearance.
"Securing this product approval marks a significant milestone, facilitating our swift penetration into the U.S. market,” noted Donghoon Shin, the CEO of Heuron. “Our commitment extends beyond this achievement as we endeavor to expand our portfolio of FDA-approved medical solutions. We are dedicated to optimizing the utilization of Heuron's diverse offerings within U.S. clinical environments, particularly for emergency patient care."
AMA Issues 2025 Category III CPT Code for the ECG-Based AI Platform EchoGo Heart Failure
July 2nd 2024The EchoGo Heart Failure platform is reportedly the only AI-powered technology to receive a CPT reimbursement code for echocardiography detection of heart failure with preserved ejection fraction.
New Study Shows Non-Radiologists Interpreting 28 Percent of Imaging for Medicare Patients
June 28th 2024While radiologists interpreted approximately 99 percent of all non-cardiac CT, MRI and nuclear medicine studies in hospital and emergency department settings for Medicare beneficiaries, new research shows significantly less radiologist review of cardiac imaging and office-based imaging.
FDA Clears Pocket-Sized ECG System and AI Technology for Detection of Cardiac Conditions
June 27th 2024Using a reduced leadset and deep neural network algorithms trained on more than 175 million electrocardiograms, the KAI 12L technology reportedly detects up to 35 cardiac determinations, including acute myocardial infarction.
