Hyperfine launches AI-powered brain imaging tech

The Swoop brain imaging system. [Image courtesy of Hyperfine]Hyperfine (Nasdaq:HYPR) announced today that it launched the AI-powered eighth generation of its Swoop brain imaging system.

The FDA cleared the new software’s diffusion-weighted imaging (DWI) AI denoising feature in October 2023. Hyperfine began rolling it out at select sites over the past several weeks in a limited market release.

Swoop’s latest updates enhance its image quality and introduce ease-of-use features. Those include a real-time aid for more precise patient loading and positioning, plus a streamlined image upload process. The software also has CE mark and approvals elsewhere to support future international expansion.

The company called Swoop the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system.

Hyperfine said that hospitals taking part in the limited release performed more than 50 exams with Swoop. Users commented favorab…

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FDA clears Hyperfine’s AI software for improved image quality on portable MRI system

Hyperfine this week announced it received FDA 510(k) clearance for its updated AI-powered software with improved image quality for its Swoop portable MRI system.

The latest software development brings artificial intelligence-based image quality enhancements to Swoop’s diffusion-weighted imaging (DWI) sequence. The software enhances the system’s AI denoising capabilities by incorporating advanced image post-processing into the DWI sequence. The improved denoising allows for crisper images that help clinicians accurately diagnose, treat and monitor patients undergoing brain imaging.

Swoop’s other sequences – T1, T2 and FLAIR – previously benefitted from the AI feature.

“We believe in making brain imaging more accessible, clinically relevant, and actionable. We continue to make meaningful progress across all sequences. With this significant and most recent update, we now incorporate deep learning into our DWI sequence,” chief operating off…

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Maria Sainz named new president, CEO at Hyperfine

Hyperfine (Nasdaq:HYPR) announced today that it named industry veteran Maria Sainz as its new president and CEO.

Sainz’s appointment becomes effective Oct. 24, 2022. Scott Huennekens, the current interim president and CEO, remains on as executive chairperson of the board.

Guilford, Connecticut–based Hyperfine develops the Swoop FDA-cleared portable MRI system.

“I am excited and honored to lead the next phase of Hyperfine’s growth as we broaden the adoption of Swoop technology, improving access to MR imaging around the world,” said Sainz. “With over 90 systems installed globally and our growing value proposition in the ICU and neurocritical care settings, we have established a strong foundation to drive forward commercial momentum. I am eager to join the Hyperfine team as we expand to additional hospitals and continue increasing our clinical applications to improve patient care in mature and emerging healthcare systems.”

Sainz joins the compa…

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Viz.ai, Hyperfine partner on new MRI, workflow paradigm

Viz.ai announced today that it partnered with Hyperfine (Nasdaq:HYPR) to bring magnetic resonance imaging (MRI) to the patient’s bedside.

San Francisco-based Viz.ai develops the Viz LVO, its flagship product designed to leverage advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat the patient.

Hyperfine develops Swoop, which it said is the world’s first MR imaging system capable of providing neuroimaging at the point of care, expanding patient access to MRI by bringing imaging to the bedside. Swoop offers a way for physicians to make quick and informed clinical decisions for patients, eliminating hours of wait and transport time, reducing the potential for adverse events associated with transporting critically ill patients.

According to a news release, the partnership and subsequent implementation into neuro ICUs provide the potential to further decrease th…

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Hyperfine unveils new software for rapid MR brain imaging

FDA recently cleared a software upgrade to Hyperfine’s portable MRI device that enables scenes in under 3 minutes with no ionizing radiation, the Austin, Texas–based company said today.

Hyperfine officials think the advancement could significantly improve the monitoring of hydrocephalus — brain fluid build-up — in children. Pediatric patients may have trouble staying still for an extended period of time in an MRI without sedation. The alternative is to do a CT scan, which includes radiation exposure.

According to Hyperfine, children with hydrocephalus typically receive more than two brain scans per year to ensure that pressure on the brain caused by enlarged ventricles remains normal. There’s also a need to rule out the possibility of shunt malfunctions.

“There is no way to prevent hydrocephalus, and there is no known cure. Young people diagnosed with this life-threatening neurological condition require life-long brain monitoring,” said Dr. K…

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Hyperfine closes SPAC merger, will begin trading on Nasdaq

Hyperfine’s Swoop portable MRI. [Image from Hyperfine]Hyperfine announced today that it completed its merger with HealthCor Catalio Acquisition Corp. and has gone public.

Guilford, Connecticut-based Hyperfine initially announced the proposed merger with HealthCor, a special purpose acquisition company (SPAC) in July.

The company will receive approximately $160 million in gross cash proceeds from the business combination and a concurrent private placement, according to a news release. The funds are earmarked for the company’s growth initiatives, including the commercial expansion of its Swoop FDA-cleared portable MRI system.

Swoop was designed to address the limitations of current imaging technologies by offering MRI for brain imaging any time, anywhere, through a console that wheels directly to a patient’s bedside, plugs into a standard electrical wall outlet and is controlled by an Apple iPad.

Hyperfine’s Class A common stock…

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Hyperfine portable MRI wins Health Canada licensing

Hyperfine’s Swoop portable MRI. [Image from Hyperfine]Hyperfine announced today that it received Health Canada licensing and began the Canadian commercial launch of its Swoop device.

Guilford, Connecticut-based Hyperfine designed its Swoop system for portable magnetic resonance imaging (MRI), touting it as the first such device to garner FDA clearance.

According to a news release, the licensing of Swoop in Canada includes the recently FDA-cleared advanced reconstruction software that uses deep learning. The system is now available for purchase in Canada.

Swoop wheels directly to a patient’s bedside, plugs into a standard electrical wall outlet and is controlled by an off-the-shelf tablet to provide rapid imaging that allows physicians to make diagnoses and determine treatment for a patient regardless of income or location.

Hyperfine said that Casey Newhouse will lead the company’s expansion in Canada with responsibilities for growin…

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MedTech 100 roundup: Industry continues climb

One week after hitting an all-time best mark, the medtech industry has done it again, reaching new heights on Wall Street.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — continued its rise, finishing the week (July 9) at 114.79 points, a rise of 0.2% from the 114.59-point mark registered a week prior on July 2.

The new high comes in was just 0.21 points ahead of the 114.58-point mark set in April — the industry’s all-time best performance before last week beat it by one point.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 24.3% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.6% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The positive movement in medtech aligns with an uptick in the overall markets this past week, as the S&P 500 Index ri…

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Hyperfine, Liminal to go public in $580M SPAC deal

Hyperfine and Liminal Sciences today said they will go public by merging with a SPAC called HealthCor Catalio Acquisition Corp.

The merger is valued at approximately $580 million upon closing and is expected to have a combined entity of $375 million in cash. The combined company’s estimated cash balance will be $207 million from the SPAC trust fund, $126 million from PIPE investors and $66 million from the balance sheets of Hyperfine and Liminal and less than $24 million in transaction expenses.

Through the deal, HealthCor Catalio will be renamed as Hyperfine and will be listed on the NASDAQ stock exchange under the ticker symbol HYPR.

“The combination of Hyperfine, Liminal and HealthCor Catalio presents an inspiring opportunity to transform the global MR imaging and brain-sensing paradigm,” Hyperfine president and CEO Dave Scott said in a news release. “This business combination will empower Hyperfine with the expanded resources, financing, and ex…

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