As the world’s first FDA-cleared bedside MRI system, Hyperfine’s portable Swoop system is designed to allow physicians to rapidly understand the current state of injury to make life-saving decisions. Within minutes, the technology can acquire critical images via a wireless tablet, powered by a standard wall outlet at the patient’s bedside. (Photo: Business Wire)
September 1, 2021 —Hyperfine Inc.announced results of a study of the company’s FDA-cleared portablemagnetic resonance imaging(MRI) device,Swoop, published inNature Communications. The study, which was conducted atYale New Haven Hospital, demonstrated high accuracy for Swoop for the detection of hemorrhagic stroke.
“Rapid determination of stroke etiology is absolutely critical to successful treatment and ensuring optimal clinical outcomes for patients,” saidKevin Sheth, M.D., Vice Chair, Clinical and Translational Research, Departments of Neurology and Neurosurgery at the Yale School of Medicine, who served as principal investigator of the study. “This study validates Swoop as an accurate method to detect and characterize intracerebral hemorrhage. The results are exciting because Swoop is readily accessible, providing clinicians with an entirely new option for rapid and convenient assessment of patients with brain injury—which will be particularly useful for settings in which CT and MRI are not readily available, such as intensive care units.”
American Heart Association(AHA) guidelines for stroke management advise that all patients receive rapid brain imaging on hospital arrival to rule out the presence of blood, which is contraindicated for thrombolytic (“clot busting”) drugs.Computed tomography(CT) has been the imaging method of choice for diagnosing hemorrhagic stroke, but growing evidence has shown that MRI is as accurate as CT for detecting acute brain hemorrhage, and avoids the radiation exposure associated with CT.
As the world’s first FDA-cleared bedside MRI system, Hyperfine’s portable Swoop system is designed to allow physicians to rapidly understand the current state of injury to make life-saving decisions. Within minutes, the technology can acquire critical images via a wireless tablet, powered by a standard wall outlet at the patient’s bedside. Because of Swoop’s portability and magnet design, care teams and loved ones can safely stay by the patient’s side during the scan, reducing patient anxiety and providing a more comfortable experience.
“In addition to being time- and resource-intensive, neuroimaging of patients with critical conditions such as brain hemorrhage has unique challenges, including their transport outside the ICU environment and the time spent in less-controlled imaging rooms,” saidMurat Günel, M.D., Professor of Neurosurgery and Professor of Genetics and of Neuroscience; Chair, Department of Neurosurgery; and Chief, Neurosurgery, for Yale New Haven Health System. “In addition, transporting patients to an MRI machine poses a potential risk to patients in critical condition due to the occurrence of potential adverse events during transfer. These results show that Hyperfine’s alternative modality may offer a breakthrough for settings in which specialized infrastructure and highly trained technicians are not readily available.”
在这项研究中，危重患者使用常规的神经成像(非对比CT或常规MRI)和Swoop便携式MRI系统进行成像。共评估144例Swoop检查。
- Blood-negative cases were correctly identified in 85 of 88 cases (96.6% specificity).
- The study found that Swoop correctly detected intracerebral hemorrhage in 45 of 56 cases (80.4% sensitivity).
- To account for confounding effects due to evolving improvements in scanner software and hardware, an identical analysis was performed in two subsets by grouping exams by software versions into the first half of the study and the second half of the study.
- 在84例病例中，有76例(总体准确率为90.5%)在扫描仪软件版本的后半部分收集的检查结果被正确分类。34例中29例为脑出血，敏感性为85.3%。
- 该研究还表明，Swoop估计的血容量与传统成像容量相关。
- In addition, Swoop-acquired intracerebral hemorrhage characteristics (blood volume) were associated with clinical outcomes.
“这项研究的结果，由我们的第一代设备和算法完成，是令人兴奋的现实世界的临床验证我们的技术，我们希望这将随着我们的深入学习软件的进步，目前正在接受FDA的审查，”saidDave Scott, Hyperfine president and CEO. “We are very pleased with the clinical response from our U.S. launch so far, and look forward to accelerating commercial expansion in the U.S. and providing greater access to Swoop innovation globally.”
In January 2021, Hyperfine received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its deep-learning image analysis software, incorporating advanced artificial intelligence (AI) to measure brain structure and pathology. The company has also submitted a new 510(k) application to the FDA for its planned incorporation of deep learning-based image reconstruction.
A link to the publication, “Portable, bedside, low-field magnetic resonance imaging for evaluation of intracerebral hemorrhage,” can be foundhere.
For more information:https://hyperfine.io/
August 12, 2022
