March 22, 2012

Vol. 9 No. 58

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Dodging the Pitfalls of FDA Advertising, Marketing Rules

Devicemakers can avoid being cited by the FDA for advertising and labeling deviations by making sure they have substantial data to back up claims and substantiate a device’s intended use, according to attorney Jeffery Shapiro of Hyman, Phelps, & McNamara. Read More

EU Guideline Tackles IVD Borderline, Classification Issues

The European Commission has published a final guideline aimed at clarifying borderline and classification issues related to in vitro diagnostic (IVD) devices. Read More

Loss of Power Turns Agency on to Recalling Blood Monitor

LifeScan Europe’s OneTouch Verio IQ blood glucose meters are being recalled due to a software glitch that may cause the meter to turn itself off when a patient attempts to access the “results log” while viewing stored results. Read More

Bill Would Mandate Medical Device IDs

Four U.S. senators have introduced legislation that would require unique identifiers for implantable medical devices and ongoing monitoring of the devices for safety issues. Read More

Medical Device Tax: Companies May Need Up to Six Months to Prepare

The 2.3 percent medical device excise tax appears simple, but tax experts are advising med-tech clients that implementing the levy will be more complex and time-consuming than most think. Read More

FDA Mulls the Role of Screening Apps, Devices

This week the US Food and Drug Administration (FDA) is holding a hearing about using innovative technologies and other mechanisms to expand the number of medications that can be administered over the counter. Read More

Court Throws Out Prometheus Patent

The Supreme Court has tossed out a medical patent for Prometheus Laboratories, a decision that could affect the burgeoning field of personalized medicine. Read More

Edward’s New Technology Offers Relief for Chronic Pain Sufferers

Edward Hospital patients have a new option in managing chronic pain. A new type of medical device similar to a pacemaker can interrupt pain signals from reaching the brain and automatically adjust the pain block as the patient needs it. Read More

Covidien Touts 510(k) Win for Nellcor Respiration Rate Software

Covidien landed an FDA win for its Nellcor respiration system with version 1.0 software and adult respiratory sensor. Read More