Search Results for 'clearance'

Buyers Guide Companies

View All Buyers Guide Companies »

• Digital Health | R&D & Design
  

  Eon FR Receives FDA Clearance

  The eon FR is a non-contact medical device that reduces fat.

  PRNewswire. 06.26.19
  

  ---

• Diagnostics | Neurological
  

  Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts

  Health Providers subscribed to the "all-in-one" AI1 package can now benefit from an additional important alert—for intracranial hemorrhage (brain bleeds).

  PR Newswire 06.18.19
  

  ---

• 

  Imperative Care Receives FDA Clearance of the ZOOM Aspiration System

  Product is used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease.

  Business Wire 06.13.19
  

  ---

• 

  Bio-Rad Receives FDA Clearance for the IH-500

  Agency's clearance expands the company's offering in the blood testing market.

  Business Wire 05.24.19
  

  ---

• 

  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
  

  ---

• 

  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
  

  ---

• Digital Health
  

  FDA Grants 510(k) Clearance to physIQ's AFib Detection Analytics Engine

  The analytic is now available for both patient care delivery as well as for safety monitoring within clinical trials.

  Business Wire 10.12.18
  

  ---

• Cardiovascular
  

  Avinger Receives FDA Clearance of Next Generation Pantheris Device

  Product is the first-ever image-guided atherectomy device for treatment of peripheral artery disease.

  Globe Newswire 07.06.18
  

  ---

• 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
  

  ---

• 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
  

  ---