Medical Devices Today

FDA Probes Potential Overlap Between Electronic Health Records And Devices

Full article reprinted from "The Gray Sheet" - March 30, 2009

Find out how a working group within FDA's device center is trying to understand the distinction between electronic health record systems and medical devices - and where the two types of products might overlap.

IRB Registration, Conduct Face Scrutiny At Oversight Hearing

Full article reprinted from "The Gray Sheet" - March 30, 2009

Find out how house legislators may seek stricter criteria for Institutional Review Board registration at the Department of Health and Human Services and require greater disclosure from IRBs following a study that revealed operational shortcomings.

AdvaMed Leads Multi-Group Endorsement Of Vendor Credentialing Standards

Full article reprinted from "The Gray Sheet" - March 30, 2009

Find out how AdvaMed hopes a proposal it released last week with 10 other health care groups will advance a dialogue to promote national harmonization for credentialing company sales representatives to work within clinical settings.

Stem Cell Therapy for Cardiovascular Disease-Progress Despite Economic Turmoil

Article preview reprinted Medtech Insight - January 2009

The Fifth International Conference on Cell Therapy for Cardiovascular Disease is one of the largest medical meetings focused solely on cell-based therapies for cardiac repair and regeneration.

CardiacAssist Builds a Bridge to the Next Bridge

Article preview reprinted from Start-Up - February, 2009

CardiacAssist operates in the market for acute heart failure, with TandemHeart a pump designed to reverse multi-organ failure, to help the heart recover, or at the very least, keep patients alive so they can move on to the next therapeutic option.

CoAxia's New Path in Stroke

Article preview reprinted from IN VIVO - February 2009

If the 1990s was the decade of the heart, this was supposed to be the decade of the brain. But the tremendous market for stroke device companies has never quite materialized in part because stroke treatment is so elusive.

PMA Panel Asks TherOx For New Data On Cath-Lab-Based Oxygen Therapy

Full article reprinted from "The Gray Sheet" - March 23, 2009

Find out how FDA's Circulatory System Devices advisory panel is encouraging TherOx to sponsor a new clinical trial of its SSO2 SuperSaturated Oxygen Therapy Downstream system to demonstrate the therapy improves clinical outcomes in heart attack patients.

HHS IG Urges Medicare To Crack Down On Negative Pressure Pump Payments

Full article reprinted from "The Gray Sheet" - March 23, 2009

Find out how CMS will consider whether it has sufficient data to curb payments for negative pressure wound therapy pumps, the agency said in response to a March 19 report by the HHS Office of Inspector General.

AHRQ’s Clancy Among Key Figures On Comparative Research Committee

Full article reprinted from "The Gray Sheet" - March 23, 2009

The Federal Coordinating Committee on Comparative Effectiveness Research includes Agency for Health Care Research & Quality Administrator Carolyn Clancy and Office of Management & Budget Special Advisor Ezekiel Emanuel.

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EuroPharma Today provides insight and analysis of regulartory, legal and financial developments impacting the biopharmaceutical industry in Europe from the publishers of "The Pink Sheet"; IN VIVO; and PharmAsia News.