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Neurological

Highmark Interactive Receives FDA Clearance for Gamified Neurological Testing Platform

‘EQ Brain Performance’ is a tool that addresses cognitive, visual and balance performance.

Highmark Interactive 10.08.19
Cardiovascular | Diagnostics

FlowMet-R Gets FDA 510K Clearance

Non-invasive blood flow monitoring device.

PRNewswire 10.02.19
Surgical

Apollo Endosurgery Receives 510(k) Clearance for Suture-Anchor Component

Reduces dependency on third party suppliers.

Apollo Endosurgery 09.18.19
Cardiovascular

Netech Obtains FDA 510(k) Clearance for Delta 3300

An instrument for testing defibrillators and pacemakers.

PRNewswire 09.09.19
Diagnostics

Device for Detecting Pre-Cancerous Barrett's Esophagus Receives FDA Clearance

A minimally invasive, cost-effective alternative to endoscopy.

Case Western Reserve University 09.06.19
Innovative Health Receives FDA Clearance to Reprocess the Webster Duo-Decapolar EP Catheter

Decision marks the company's fifth EP reprocessing clearance this year.

Innovative Health 08.26.19
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
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
Research Shows New Active Drain Line Clearance System Improves Data Accuracy

Accuryn has potential to guide more precise fluid therapy for burn patients, resulting in better care and lower mortality.

Business Wire 05.05.17
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