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.

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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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