FDA Approves ‘World’s First’ Portable Bedside MRI Scanner Costing 20 Times Less Than Current Systems. Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its deep-learning image analysis software. Hyperfine says the unit is 20 times less costly to build, 10 times lighter, and uses 35 times less power than a 1.5 Tesla MRI. Hyperfine Research has secured 510 (k) clearance from the US Food and Drug Administration (FDA) for its Swoop portable magnetic resonance imaging (MRI) system. 7/30: Portable MRI in Emergency Medicine. The company’s original Portable MRI system received its first US FDA 510(k) clearance in February, 2020 for head imaging of patients 2 years of age and older. The Hyperfine system is 20 times lower cost, 35 times lower power consumption, and 10 times less weight than today’s fixed conventional MRI systems. Compared to conventional MRI systems, Hyperfine system is 20x lower cost, consumes 35x lower power and has 10x lower weight. Now, the company has obtained FDA clearance for its second-generation portable MRI device, called the Swoop. And it’s spurring Rothberg to dream big. FDA Clearance – The Hyperfine MRI was cleared for head imaging of patients 2 years and older, suggesting that it will primarily see use in emergency and neuro ICU settings. The FDA clearance includes head imaging for patients 2 years of age and older. Show detailed description. Hyperfine secures $90M to help roll out its portable MRI scanner. Hyperfine is on a mission to bring MRI technology to every patient anywhere, anytime, regardless of income or resources. Hyperfine is now accepting product pre-orders via www.hyperfine.io. FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF. Hyperfine's AI software for portable MRI clears FDA By AuntMinnie.com staff writers. Hyperfine’s Swoop™ Portable MR Imaging System is designed to address the limitations of current imaging technologies and make MRI accessible anytime, anywhere, to any patient. The FDA clearance includes head imaging for patients 2 years of age and older. Hyperfine Research has secured 510(k) clearance from the US Food & Drug Administration (FDA) for its bedside magnetic resonance imaging (MRI) system. The system weighs less than conventional MRI systems and uses less power. Hyperfine Research of Guilford, Connecticut, announced the development this week, saying the algorithms work with the company’s portable MRI machine called Swoop and are included in the system’s standard software setup. Hyperfine Research has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Swoop Portable MR imaging device. An AI application that interprets MRI scans of the brain for signs or confirmation of injury has received 510(k) clearance from the FDA. Participants with known or suspected hydrocephalus will receive brain scans using the Hyperfine, low field strength, portable, magnetic resonance imaging (MRI) system in addition to their scheduled outpatient standard of care clinical computed tomography (CT) or MRI scan. Detailed Description: Ferumoxytol is a superparamagnetic iron oxide nanoparticle (SPION) preparation that was originally designed as an MRI contrast agent, but later received FDA approval as a treatment for iron deficiency anemia. Claimed to be the world’s first bedside MRI system, the Hyperfine system has been developed to overcome the limitations of current MRI systems and allow to access MRI anytime and anywhere to any patient. What if you could increase access and decrease wait times by bringing the MRI directly to the Emergency Department? Jonathan Rothberg, Earlier this year, Hyperfine, a company with offices in New York City and St Guilford, Connecticut, won the first FDA clearance for a portable MRI that can be taken into patient rooms. Hide detailed description. Hyperfine Research of Guilford has created a portable magnetic resonance imaging unit. January 14, 2021-- Hyperfine's artificial intelligence (AI) image analysis software for the company's Swoop portable MRI system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).. Hyperfine's Advanced AI Applications will be incorporated into the standard software package for Swoop. Swoop is a point-of-care (POC) MR imaging device, which can be directly placed at the patient’s bedside and connected to a standard electrical wall outlet. Hyperfine received market-ready FDA clearance for its portable MR imaging for the brain and head of patients of all ages in August 2020. About Hyperfine. The FDA has approved 510 (k) clearance for the Hyperfine Research Inc. bedside Magnetic Resonance Imaging (MRI) system, the world’s first bedside MRI. The MRI that comes to your patients. Hyperfine is now accepting product pre-orders via www.hyperfine.io. 1 was here. Credit: Business Wire. 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. Portable, simple -- SHIPPING NOW! In this webinar (recorded July 20th, 2020) three emergency medicine experts share how they are doing just that with the Hyperfine Portable MRI. The device can be wheeled to a patient’s bedside and plugs directly into a standard electrical wall outlet. Let’s use the wonders of high-field MRI for the appropriate patients, and deploy Swoop™ at the point-of-care for everyone else. Lower, Lower, Lower – Hyperfine leaned-in on its MRI’s size and cost value proposition, touting its “20X lower cost, 35X lower power consumption, and 10X lower weight” than conventional MRI systems. The company’s original Portable MRI system received its first US FDA 510(k) clearance in February, 2020 for head imaging of patients 2 years of age and older. Earlier this year, Hyperfine, a company with offices in New York City and St Guilford, Connecticut, won the first FDA clearance for a portable MRI that can be taken into patient rooms. The FDA granted Hyperfine Research 510(k) clearance for its portable bedside magnetic resonance imaging (MRI) system. If you have a background in MRI, deep learning, electrical engineering, physics, or related fields, apply to join our interdisciplinary team of passionate, driven people based in Guilford, CT and NYC. Hyperfine Research Inc., founded by Connecticut bioscience entrepreneur Jonathan Rothberg, said the new FDA clearance covers enhanced imaging and software, while expanding brain imaging to include patients up to age 2. www.fda.gov February 6, 2020 Hyperfine Research, Inc. ℅ Mr. Brian Sawin Sr. Regulatory Affairs Manager 530 Old Whitfield Street GUILFORD CT 06437 Re: K192002 Trade/Device Name: Lucy Point-of-Care Magnetic Resonance Imaging Device Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 7, … Hyperfine received FDA for its category-defining portable MRI technology, the Swoop Portable MR imaging system. Hyperfine is on a mission to make MRI accessible to every patient regardless of income or resources, anywhere, anytime. Hyperfine is on a mission to make MRI accessible to every patient regardless of income or resources, anywhere, anytime. Share Article. FDA clears new version of Hyperfine's portable MRI scanner-on-wheels. GUILFORD — Officials with Hyperfine Research said Wednesday the company has received U.S. Food and Drug Administration clearance to begin selling a bedside MRI system. Swoop™ wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled by an Apple iPad®. Unfortunately, it also remains inaccessible. Hyperfine has received 510(k) clearance from the US FDA for its category-defining portable MRI technology, the Swoop™ Portable MR imaging system. Device: Hyperfine Portable MRI. A Guilford company has picked up another FDA clearance for its portable MRI machine, this time allowing the device to be used to image the brains of newborns. Commenting on the FDA 510(k) clearance of the system, Hyperfine CEO Dr Khan Siddiqu said: “More than 40 years after its first use, MRI remains a marvel. It is controlled using a wireless tablet, such as an iPad. Hyperfine is on a mission to make MRI accessible to every patient regardless of income or resources, anywhere, anytime.