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  CathWorks FFRangio System Receives FDA Clearance

  The FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions.

  Business Wire 02.07.19
  

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• Patient Monitoring
  

  IRADIMED Corporation Announces 510(k) Clearance of Invasive Blood Pressure Module

  Product is designed for use with the company's MRI-compatible patient vital signs monitor.

  Globe Newswire 02.05.19
  

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• Diagnostics
  

  Fully Automated BD Phoenix CPO Detect Test Receives FDA Clearance

  New test helps hospitals more quickly identify and treat emerging antibiotic-resistant bacteria.

  PR Newswire 01.08.19
  

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• Patient Monitoring
  

  Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance

  Bruin Biometrics' SEM Scanner directs clinicians to heels and sacrums at risk of developing pressure ulcers, even before the damage is visible.

  PR Newswire 01.03.19
  

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  Helius Medical Technologies Receives Canadian Clearance for PoNS Device

  Device is designed to improve balance in patients following a mild-to-moderate traumatic brain injury.

  Globe Newswire 12.03.18
  

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  iSchemaView Receives FDA Clearance for RAPID CTA

  RAPID CTA automatically provides clear, easy to interpret CTA maps.

  Business Wire 06.07.18
  

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  Contrast Clearance Analysis Software Receives FDA 510(k) Clearance

  Scientists evaluate MR-based technology for differentiating treatment effects.

  Businesswire 01.05.18
  

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• Electronics | Patient Monitoring
  

  Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use

  Product is the only device of its kind legally available without a prescription in the United States.

  Capillus LLC 02.21.17
  

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• Cardiovascular | Testing

  FDA Grants De Novo Clearance to HeartFlow Imaging System

  HeartFlow Inc. has received de novo clearance from the U.S. Food and Drug Administration for its FFRCT technology, a non-invasive imaging technique for coronary artery disease that provides doctors with insight on both the extent of the blockage as w…

  04.08.15
  

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• Materials

  Promoting Medical Devices Prior to FDA Approval or Clearance

  Promoting Medical Devices Prior to FDA Approval or Clearance James R. Ravitz, Arent Fox PLLC Earlier this year, this column examined the FDA’s regulations and trends with respect to direct-to-consumer advertising. Now we’ll exam…

  James R. Ravitz 10.21.06
  

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