Ad Council

Product Approval & Certification

Soft Tissue Ablation System Cleared

A new ultrasound system that ablates soft tissue received marketing approval from the Food and Drug Administration. The Sonatherm 600i High Intensity Focused Ultrasound (HIFU) Soft Tissue Ablation System is manufactured by Misonix, Incorporated. This device is indicated to treat patients with soft tissue lesions. more...

July 21, 2008 Related topics: Product Approval & Certification, Imaging, Surgery

New Contrast Delivery System Launched

Covidien announced the launch of a new contrast delivery system, the Optistar Elite Contrast Delivery System. The product was recently cleared by the Food and Drug Administration. The device was already cleared for marketing in Europe and marketing applications are pending in other countries. more...

July 21, 2008 Related topics: Product Launches, Product Approval & Certification, Imaging, Quality, Safety, Errors

New Device to Treat Vertigo Approved

The new Omniax device, designed to both diagnose and treat patients with vertigo, was cleared for marketing by...

New Ventilator from Drager Cleared for Market

Drager Medical recently launched a new ventilator, the Carina, designed for sub-acute settings. The system received marketing...

Blood Product Solution Cleared for Commercial Marketing

A new transfusion safety management system from IntelliDOT Corporation, the IntelliDOT Blood Product Administration (IntelliDOT BPA), was cleared...

Breast Cancer Test Introduced

The Food and Drug Administration issued marketing clearance to Invitrogen Corporation for the company’s new genetic breast cancer...

Heart Device Monitor Approved, Simplifies Patient Monitoring

A new remote monitoring device from St. Jude Medical, Incorporated was granted marketing clearance from the Food and...

Intel Personal Health System Cleared

The Food and Drug Administration approved a new personal in-home health monitoring system manufactured by computer chip giant...

New Glucose Management System from J&J Approved

The new OneTouch Ping, designed and manufactured by Johnson & Johnson subsidiary Animas, was approved by the Food...

Contura MLB Approved Cleared for Marketing

SenoRX, Incorporated received an additional marketing approval from the Food and Drug Administration for the company’s Contura MLB...

Next Generation XIENCE Launched

Abbott Laboratories received marketing clearance for the company’s most up-to-date iteration of the XIENCE stent, the XIENCE V...

CoHesion Module Approved by the Feds

A cooperative product, the CoHesion 3D Visualization Module, was granted marketing clearance by the U.S. Food and Drug...

DPS System for Breathing Support Approved by Feds

The NeuRx Diaphragm Pacing System (DPS) supports breathing for patients who are ventilator-dependent and is manufactured by Synapse...

New Replacement Device for Lumbar Spine Market Ready

LDR Holdings, a company that specializes in the development of tools for spinal surgery, announced the FDA approval...

Datascope Anaesthesia System Cleared

The new AS3000 anaesthesia delivery system was approved by the Food and Drug Administration. The product was designed...

Adaptive CT Scanner Launched by Siemens

The new SOMATOM Definition AS, an adaptive CT scanner, manufactured by Siemens Healthcare received marketing clearance (pdf) from...

Esophageal Stent from Cook Approved

Cook Medical received marketing clearance from the Food and Drug Administration for their Evolution Controlled Release Esophageal Stent...

New Thoracic Stent Graft Blessed for Marketing

The Talent Thoracic Stent Graft manufactured by Medtronic was cleared for marketing by the Food and Drug Administration....

Transplant Compatibility Tool from Invitrogen Approved

The new DynaChip Antibody Analysis System from Invitrogen Corporation was approved by the Food and Drug Administration for...

Impella Device Approved by Feds

The Food and Drug Administration granted marketing clearance for the Impella 2.5 Cardiac Assist Device. The device is...

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