#Canada #FDA Clearance #Surrey #mlHealth 360 #Scaida BrainCT-ICH

mlHealth 360 Achieves FDA Clearance for Scaida BrainCT-ICH

In an industry breakthrough, mlHealth 360 has recently announced that their innovative AI-driven solution, Scaida BrainCT-ICH, has received clearance from the U.S. Food and Drug Administration (FDA) under the 510(k) program. This significant regulatory milestone establishes Scaida BrainCT-ICH as the first AI tool for intracranial hemorrhage (ICH) triage developed in Canada to be authorized for clinical use within the United States.

Recently, healthcare facilities globally have been grappling with an unprecedented surge in imaging demands, leading to heightened cognitive load on radiologists, which in turn increases the risk of burnout. Traditional radiology workflows can result in critical emergency studies remaining unexamined during crucial moments, thereby posing potential risks to patient health. The introduction of Scaida BrainCT-ICH is aimed at solving these operational bottlenecks by providing automated prioritization for critical cases.

At the core of Scaida BrainCT-ICH's functionality is the principle that "Time is Brain." This AI solution is designed to maintain continuous surveillance, automatically analyzing non-contrast head CT scans immediately after they are performed. In instances where the AI detects a potential hemorrhage, it promptly alerts the medical team and elevates the study to the top of the radiologist's worklist. This mechanism ensures that urgent findings receive immediate attention rather than languishing in a backlog, thereby allowing for swift interventions in critical situations.

The operational impact of Scaida BrainCT-ICH is profound. By enhancing workflow efficiency, it delivers genuine returns on investment for hospital systems, primarily by optimizing existing resources. According to Mahesh Shankar, the Director of Advanced Analytics Innovation at mlHealth 360, the tool is engineered to function as a force multiplier for radiologists rather than a distraction. With a specificity rating of 0.887, Scaida BrainCT-ICH significantly reduces the incidence of false positives, thereby alleviating alert fatigue and allowing radiologists to rely on the AI notifications they receive with greater confidence.

Key operational advantages attributed to this AI solution include:

• - Rapid Processing: Scaida BrainCT-ICH boasts an impressive average processing time of just 5.97 seconds, minimizing potential workflow delays.
• - Seamless Integration: This tool integrates smoothly with pre-existing Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS), ensuring a smooth transition into current hospital infrastructures.
• - Efficient Resource Allocation: By decreasing the time required to evaluate high-acuity cases, especially during peak hours in emergency rooms, hospitals can elevate patient care quality.

The FDA clearance achieved by mlHealth 360 underlines a pivotal validation of their mission to develop a scalable intelligence framework for modern radiology practice. ICH triage represents one of the most urgent challenges encountered in critical care environments. With this FDA approval as a foundation, the company plans to expand its AI capabilities into other areas such as chest, abdominal, and whole-body imaging to better support healthcare systems worldwide.

Moreover, the performance of Scaida BrainCT-ICH has been validated through rigorous testing conducted in six U.S. medical institutions featuring a variety of scanner manufacturers, including GE, Toshiba, and Siemens. The collected data has outlined key performance indicators: a specificity of 0.887, sensitivity of 0.867, and an Area Under the Curve (AUC) rating of 0.926, demonstrating the effectiveness of the AI solution in practical settings.

The primary intended use of Scaida BrainCT-ICH is to assist trained radiologists by flagging suspected instances of intracranial hemorrhage, thereby enhancing workflow triage within emergency care units. It is important to note that the device does not alter original medical images or serve as a standalone diagnostic tool.

As a leading healthtech company, mlHealth 360 is on a mission to transform the landscape of radiology through secure, cloud-based AI solutions. Their platforms are designed to accelerate reporting speeds and enhance overall healthcare efficiency, all while ensuring compatibility with existing hospital systems. For further information, visit mlHealth 360's official website at https://mlhealth360.com/ and their LinkedIn profile at https://www.linkedin.com/company/mlhealth-360.