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Hyperfine (HYPR) Progresses in MRI Space With Latest FDA Nod

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Hyperfine, Inc. (HYPR - Free Report) has received FDA clearance for its updated software for the Swoop system. This development aligns with the company’s efforts to strengthen its foothold in the growing Magnetic Resonance Imaging (MRI) space.

The Swoop system is the world's first FDA-cleared portable magnetic resonance brain imaging system. The FDA nod for the updated version of the system marks another significant step forward. This latest approval is the eighth FDA software clearance for the Swoop system in just three years.

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The updated software introduces image quality enhancements to the Swoop system's diffusion-weighted imaging (DWI) sequence. The core of this development lies in the incorporation of advanced image post-processing through artificial intelligence (AI) into the DWI sequence. While other sequences (T1, T2, and FLAIR) in the Swoop system already utilize the power of AI for image enhancement, this latest software update extends these capabilities to the DWI sequence.

Denoising leads to crisper and more detailed images, potentially providing clinicians with a more accurate and reliable tool for diagnosing, treating and monitoring patients undergoing brain imaging.

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Hyperfine, in this regard, highlighted the importance of imaging improvements in time-sensitive healthcare environments. The enhanced image quality is expected to help healthcare professionals make quicker, more precise decisions for their patients. This advancement is also expected to make brain imaging more accessible and clinically relevant.

Hyperfine plans to roll out the updated Swoop system software in the coming months.

Market Prospects

Going by a Grand View Research report, the global MRI was valued at $5.26 billion in 2022. It is projected to expand at a CAGR of 6.8% over the forecast period of 2023-2030. Several factors are driving this growth.

Per the report, MRI has proven to be an efficient diagnostic tool for a range of medical conditions, including spine lesions, tumors, and strokes affecting the brain and blood vessels. With the rising prevalence of these diseases, the demand for MRI machines is expected to increase significantly.

Furthermore, the demand for quick and effective diagnostic procedures is on the rise, leading to the installation of MRI machines in various countries. The integration of AI into MRI technology is also expected to boost market growth. AI-enabled MR imaging portfolios, like the one launched by Philips, promise to enhance efficiency and diagnostic quality.

Share Price Performance

Over the past year, shares of HYPR have surged 71.3% compared with the industry’s 1.8% rise.

Zacks Rank and Key Picks

Hyperfine currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Quanterix (QTRX - Free Report) and Align Technology (ALGN - Free Report) , each carrying a Zacks Rank #2.

DaVita has an estimated long-term growth rate of 12.7%. DVA’s earnings surpassed estimates in three of the trailing four quarters and missed once, with the average surprise being 21.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

DaVita has gained 25.5% against the industry’s 8.9% decline over the past year.

Estimates for Quanterix’s 2023 loss per share have remained constant at 97 cents in the past 30 days. Shares of the company have surged 141.5% in the past year compared with the industry’s fall of 5.6%.

QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.

Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 27% in the past year compared with the industry’s rise of 14.3%.

ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it delivered an earnings surprise of 9.90%.

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