Ad Council

Product Approval & Certification

Catheter for Subcutaneous Implantation Cleared

InterradMedical, Incorporated received marketing clearance from U.S. Food and Drug Administration for the organization's SecureAcath PICC. The new device is a catheter that incorporates a subcutaneous securing system. more...

October 7, 2008 Related topics: Product Approval & Certification, Surgery

CCHIT Announces Newly Certified EHRs

The Certification Commission for Healthcare Information Technology (CCHIT) announced the most recently certified electronic health record (EHR) systems designed for office-based physicians. This is the first series of systems that were approved considering the new criteria for 2008. more...

October 7, 2008 Related topics: Product Approval & Certification, IT & software

Mitral Valve for Common Diseases Introduced

Edwards Lifesciences announced approval from the Food and Drug Administration for the company’s new Carpentier-Edwards PERIMOUNT Magna mitral...

Test for Colon Cancer Staging Introduced

A new test to support staging of colon cancer (pdf), available from DiagnoCure Oncology Laboratories, will now be...

Silver-Coated Luer Access Device Introduced

The first antibacterial Luer Access Device (LAD) impregnated with silver was approved by the Food and Drug Administration....

One Hour Tests from Cepheid Approved

Cepheid Incorporated received approval from the Food and Drug Administration for new rapid diagnostic tests, the Xpert MRSA/SA...

Bacterial Detection Test from Verax Cleared for Market

In addition to the recent FDA approval, Verax Biomedical, Incorporated received the CE mark for its Platelet PGD...

Anastomosis System for Cardiac Bypass Introduced After Clearance

The PAS-Port Proximal Anastomosis System from Cardica received marketing clearance from the Food and Drug Administration. The system...

New Annuloplasty Devices from MiCardia Approved

The Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR, both manufactured by MiCardia Corporation, were approved for marketing...

Hep B Viral Load Test Cleared

Roche Medical Diagnostics announced FDA approval of a new diagnostic assay (pdf) that quantifies the viral road of...

Agendia Test Pinpoints Ideal Therapy

TargetPrint, a test for breast cancer specimens, was recently launched by Agendia. This new diagnostic test was designed...

Alert System for Defibrillators Introduced by Medtronic

Medtronic introduced a new device safeguard product, Lead Integrity Alert (LIA) software. The solution received approval from the...

New Test Assesses Heart Transplant Patients

A new, non-invasive test developed by XDx, Incorporated allows clinicians to evaluate patients following a heart transplant. The...

Peripheral Occlusion Tool Approved

The new PowerAssert radiofrequency (RF) guidewire from Stereotaxis, Incorporated was approved by the Food and Drug Administration. The...

New Radiation Therapy System Cleared

New radiation therapy technology, TomoDirect, from TomoTherapy, Incorporated received marketing approval from the U.S. Food and Drug...

Heat Exchange Catheter Cleared for Marketing

Alsius, a company dedicated to the development of products to control patient temperature in critical care, recently announced...

ABAS Software Assesses Anatomy Boundaries

A new solution which estimates anatomy boundary contours (pdf) from CMS, Incorporated was cleared for marketing by the...

New Glucose Monitors from Home Diagnostics Cleared

Two new blood glucose monitors manufactured by Home Diagnostics, Incorporated were given the green light for marketing by...

Blood Bank Reagents from Biotest Cleared

A line of blood bank reagents from Biotest Diagnostics Corporation received final approval from the Food and Drug...

Surgical Ablation Products Cleared for Market

A new, next generation high intensity focused ultrasound (HIFU) tool from St. Jude Medical were cleared for marketing...

http://www.hospitalbuyer.com