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Canon Medical’s AI-Powered, Premium Large Bore CT Receives FDA Clearance

Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB CT system, giving clinicians the opportunity to see more during radiation therapy planning for accuracy, precision and speed.

FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system.

FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

Accumen’s 3DR Labs Partners with Resonance Health

Accumen Inc. has announced that its 3DR Labs LLC company is partnering with Resonance Health Limited to provide FerriSmart magnetic resonance imaging- (MRI-) based liver iron concentration reports for its clients.

FerriSmart uses artificial intelligence (AI) to analyze MRI images and deliver a liver iron quantification result within seconds. This technology allows liver iron concentrations to be monitored effectively and efficiently for individuals with confirmed or suspected systemic iron overload, patients with thalassemia or sickle cell anemia who require regular blood transfusions, and recipients of artificial heart valves who may experience an increase in systemic iron levels over time.

“We are excited to partner with Resonance Health to provide our clients with this additional resource for mining valuable diagnostic data from their MRI images,” said Accumen President and CEO Jeff Osborne. “3DR is already working with 900 hospitals in the United States, creating three-dimensional images from their MRI and computed tomography scans. We consider FerriSmart Reports to be a natural extension to the comprehensive MRI analysis services that we already offer to our 3DR clients.”

“We are delighted to partner with 3DR Laboratories and significantly increase the number of patients who can benefit from our non-invasive, MRI-based FerriSmart technology. This important liver iron concentration information can provide invaluable insights and help to guide their treatment options,” said Resonance Health CEO Alison Laws.

“Iron deposition disorders, such as sickle cell disease and thalassemia, are a significant health problem not only in the U.S. but worldwide. 3DR is thrilled to partner with Resonance Health in delivering a safer, easier and less expensive AI-based technology to help care for these patients,” said 3DR Labs Chief Medical Officer Robert L Falk, MD.

Sickle cell disease is a group of inherited red blood cell disorders, characterized by hard, sticky, c-shaped red blood cells. These red blood cells die early, so they are always in short supply. They also tend to cause blood clots, which can result in pain, infection, acute chest syndrome and stroke.[1] The US Centers for Disease Control and Prevention estimates that sickle cell disease affects approximately 100,000 Americans and millions of people throughout the world.[2]

Thalassemia is a group of inherited disorders in which there is reduced hemoglobin levels, decreased red blood cell production and anemia.[3] They are sub-divided into alpha-thalassemia and beta-thalassemia depending on whether the mutation occurs on the alpha or beta chain of the hemoglobin molecule.[4] The incidence of symptomatic cases of beta thalassemia is estimated to be approximately 1 in 100,000 individuals worldwide.[3]

Resonance Health has received 510(k) clearance for FerriSmart from the US Food and Drug Administration, a CE mark from the European Medicines Agency, and regulatory clearance from the Therapeutic Goods Administration in Australia.

References

  1. https://www.cdc.gov/ncbddd/sicklecell/facts.html
  2. https://www.cdc.gov/ncbddd/sicklecell/data.html
  3. https://rarediseases.org/rare-diseases/thalassemia-major
  4. https://www.mayoclinic.org/diseases-conditions/thalassemia/symptoms-causes/syc-20354995

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