More News of Interest

Centers for Medicare and Medicaid Services Grants Transitional Pass-through Payment for the Spine Jack System

"The CMS Transitional Pass-Through payment determination is a monumental step in providing a superior device technology in the treatment of osteoporotic vertebral compression fractures," said Greg Siller, Vice President and General Manager of Stryker's Interventional Spine business.

Philips to Introduce Latest Advancements In Digital Pathology at the European Congress of Pathology 2020 Virtual Event

Building on its strong portfolio to support oncology clinical decision-making, the company brings together the power of imaging, pathology, genomics, and longitudinal data with insights from artificial intelligence, to empower clinicians to deliver clear care pathways with predictable outcomes for every patient.

Zenith Award from American Association for Respiratory Care for Support of Respiratory Therapists Is Awarded to Vapotherm

Award celebrates excellence in support and quality as chosen by AARC member votes

Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Market Ready Swoop Portable MRI System Receives 510(k) FDA Clearance

Swoop Portable MRI 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. Today Hyperfine announced has received 510(k) clearance from the US FDA.

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 Portable MRI System is now available for purchase, with shipments commencing immediately.

Magnetic Resonance Imaging uses a magnetic field, radio waves and a computer to produce detailed pictures of the body’s internal structures that are clearer, more detailed and more likely in some instances to identify and accurately characterize disease than other imaging methods. However, fixed MRI systems can be inconvenient and inaccessible for providers and patients, particularly when time is critical. Transport to the MR suite demands complicated scheduling coordination, moving patients, and, often, 4 to 6-hour patient backlogs – all which compromise the utility of MRI as a diagnostic tool in time-sensitive settings such as intensive care units and emergency rooms. Furthermore, high capital investments, electrical power needs, and significant maintenance requirements present a barrier to adoption across all populations, acutely so for developing countries and rural geographies.

Hyperfine’s Swoop Portable MRI System was designed to address the limitations of current imaging technologies and make MRI accessible anytime, anywhere, to any patient. Swoop™ wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled by a wireless tablet such as an Apple iPad®. Images are captured at the patient’s bedside, with results in minutes, enabling critical decision-making capabilities across a variety of clinical settings including neurointensive care units, emergency departments, pediatrics, ambulatory, outpatient surgery centers, and more. The complete Hyperfine system costs less than the annual service contract alone for most current MRI systems, and it consumes 35 times less power than those same systems. Designed as a complementary system to traditional MRIs, new users can be trained on system operation, device navigation, and device safety in about 30 minutes, helping clinicians to streamline workflow.

“Six years ago, we had a crazy vision to create a new product category for imaging: an affordable point-of-care MRI system. With this clearance from the FDA, we are launching an astonishing new diagnostic tool for patients and providers in our Swoop™ Portable MRI, and we are delivering on our mission to democratize healthcare across clinical settings and geographies,” said Jonathan Rothberg, Ph.D., founder, and chairman of Hyperfine Research.

Latest Posts

Centers for Medicare and Medicaid Services Grants Transitional Pass-through Payment for the Spine Jack System

"The CMS Transitional Pass-Through payment determination is a monumental step in providing a superior device technology in the treatment of osteoporotic vertebral compression fractures," said Greg Siller, Vice President and General Manager of Stryker's Interventional Spine business.

Philips to Introduce Latest Advancements In Digital Pathology at the European Congress of Pathology 2020 Virtual Event

Building on its strong portfolio to support oncology clinical decision-making, the company brings together the power of imaging, pathology, genomics, and longitudinal data with insights from artificial intelligence, to empower clinicians to deliver clear care pathways with predictable outcomes for every patient.

Zenith Award from American Association for Respiratory Care for Support of Respiratory Therapists Is Awarded to Vapotherm

Award celebrates excellence in support and quality as chosen by AARC member votes

Fusion Antibodies and Queen’s University Belfast Awarded a £453,000 Grant from Invest Northern Ireland

The two organisations will use the funds to accelerate the discovery of novel therapeutic and diagnostic antibodies with validated anti-infective properties against COVID-19. Building on strong scientific knowhow, a new antibody development platform will be created that will help realise the vision of producing a breakthrough therapeutic that directly targets SARS-CoV-2.

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New England Biolabs® Introduces NEBNext® Custom RNA Depletion Design Tool and RNA Depletion Core Reagent Set for Customizable RNA Depletion

This technology has been superb for eliminating the ribosomal RNA for a range of custom projects, including tracking novel viruses in mosquitoes, longitudinal profiling for astronauts, and host-pathogen interactions in COVID samples.

INTERCEPT Blood System for Cryoprecipitation Receives FDA Approval States Cerus Corporation

"FDA approval of the INTERCEPT Blood System for Cryoprecipitation is an important step forward in our mission to establish pathogen reduction as the standard of care for transfused blood components globally," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

Genetron Health Provides Update on HCCscreen™ for Liver Cancer Early Screening in China

Led by the Wuxi municipal government and administered by the National Cancer Center in China, the “Liver Cancer Early Screening Comprehensive Prevention and Control Project” is a public health initiative.

Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision

ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.

OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

OrganBio, a Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials.