Search Results for 'clearance'
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Surgical
Sony Receives FDA Clearance for NUCLeUS
The smart operating room platform becomes available for sale in the U.S.Sony 01.29.20
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ZipThaw Receives FDA Clearance
A dry, portable precise plasma thawing medical device.PRNewswire 01.06.20
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Cardiovascular | Diagnostics | Software & IT
HeartVista Receives FDA 510(k) Clearance for Cardiac MRI Package
Prescribes the standard cardiac views with just one click.HeartVista 10.29.19
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Cardiovascular | Diagnostics
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TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System
Company receives clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy procedures.Business Wire 07.10.18
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Mauna Kea Obtains FDA Clearance for Applications of Cellvizio Confocal Laser Endomicroscopy
Product provides unique response to unmet needs during brain and spinal surgeries.Business Wire 07.09.18
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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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Cardiovascular
FlowAid Receives FDA Clearance for the FA100 SCCD
The device is used for the treatment of diseases and discomforts that can be relieved by increased blood flow.Business Wire 02.24.17
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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
