• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

FDA clears Sonosite’s hand-held ultrasound

Article

SonoSite of Bothell, WA, this month received premarket clearance for its digital hand-held ultrasound unit. The company announced April 5 that the Food and Drug Administration had cleared the device and that SonoSite would begin its marketing

SonoSite of Bothell, WA, this month received premarket clearance for its digital hand-held ultrasound unit. The company announced April 5 that the Food and Drug Administration had cleared the device and that SonoSite would begin its marketing efforts.

Last May, SonoSite’s prototype device received premarket clearance, which covered 11 clinical applications including obstetrical, gynecological, abdominal, and cardiovascular imaging (SCAN 5/13/98). The new clearance covers such updates to the prototype as increased signal processing ability, and adds transrectal imaging to the device’s list of applications. SonoSite’s scanner will weigh less than 6 pounds and the firm expects to begin selling the units late this year.

The company moved quickly to establish distributor partnerships for the unit, announcing April 7 that it had signed an agreement with Esaote of Genoa, Italy. The agreement gives Esaote distribution rights for the new device in Germany, France, Italy, and the Netherlands.

Related Videos
Improving the Quality of Breast MRI Acquisition and Processing
Can Fiber Optic RealShape (FORS) Technology Provide a Viable Alternative to X-Rays for Aortic Procedures?
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Can Diffusion Microstructural Imaging Provide Insights into Long Covid Beyond Conventional MRI?
Assessing the Impact of Radiology Workforce Shortages in Rural Communities
Emerging MRI and PET Research Reveals Link Between Visceral Abdominal Fat and Early Signs of Alzheimer’s Disease
Reimbursement Challenges in Radiology: An Interview with Richard Heller, MD
Nina Kottler, MD, MS
The Executive Order on AI: Promising Development for Radiology or ‘HIPAA for AI’?
Related Content
© 2024 MJH Life Sciences

All rights reserved.