FDA Clears Hyperfine’s Swoop Portable MRI System
Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its category-defining portable MRI technology, the Swoop™ Portable MR imaging device. Hyperfine’s Swoop™ system is a point-of-care MR imaging device that wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet and is controlled through a wireless tablet, making MR imaging accessible, immediate and seamless.
This clearance for the market-ready device covers enhanced imaging and software, and expands Hyperfine’s brain imaging indication to include patients aged 0 to 2. Swoop™ is the company’s latest-generation device, incorporating user feedback and technological enhancements evolving from the original device, which was cleared in February, 2020. With this clearance, the Swoop™ system is now available for purchase, with shipments commencing immediately.
NCCN Now Recommends Breast Cancer Index for Predicting Benefit from Extended Endocrine Therapy
The Breast Cancer Index assay is the only of its kind to be recommended in the National Comprehensive Cancer Network Guidelines for the treatment of breast cancer as being predictive of extended adjuvant endocrine therapy.
Breast Cancer Index (BCI), a molecular gene expression–based test used for determining which patients with early-stage, hormone receptor (HR)–positive breast cancer benefit from extended endocrine therapy, is now included in the National Comprehensive Cancer Network (NCCN) Guidelines for breast cancer, according to Biotheranostics, Inc.
Per NCCN recommendations, BCI can be used for consideration of extended adjuvant endocrine therapy with a 2A category of evidence and consensus, which indicates uniform consensus from the organization that the recommendation is appropriate.
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ED Sonographic Score Helps Rule in or Exclude Acute Cholecystitis
A bedside scoring tool could help identify or rule out sonographic acute cholecystitis (SAC) in the emergency department (ED), researchers say.
The study builds on previous work and “defines a way to potentially rule in or out acute cholecystitis at the time of initial presentation, using only history, physical exam, and bedside ultrasound,” Dr. Andrew Liteplo of Massachusetts General Hospital in Boston told Reuters Health by email.
“While mid-range scores may be indeterminate and thus require additional work-up, a low (<2) Bedside SAC Score effectively rules out acute cholecystitis and a high (7 or greater) score essentially rules it in,” he said.
“Proficiency in performance and interpretation of point-of-care ultrasound is important,” he noted, “but this is a skill that emergency physicians and doctors in other specialties learn during training and incorporate routinely into daily clinical practice.”