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Diagnostics | Patient Monitoring | Software & IT
Subtle Medical's SubtlePET Gains FDA Clearance & CE Mark
SubtlePET is the first AI product cleared for medical imaging enhancement.PR Newswire 12.05.18
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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
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IsoRay Granted FDA Clearance for GammaTile Therapy
Agency gives company permission to use the therapy to treat recurrent brain neoplasms.Globe Newswire 08.14.18
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Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System
Product features simultaneous intravascular ultrasound and optical coherence tomography capabilities.Business Wire 06.07.18
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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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IRADIMED CORPORATION Announces FDA Clearance of MRI Compatible Patient Vital Signs Monitor
Product is rated for operations in magnetic fields up to 30,000 gauss.Globe Newswire 11.09.17
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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
