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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.
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The European Commission has published a final guideline aimed at clarifying borderline and classification issues related to in vitro diagnostic (IVD) devices.
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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.
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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.
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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.
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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.
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The Supreme Court has tossed out a medical patent for Prometheus Laboratories, a decision that could affect the burgeoning field of personalized medicine.
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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.
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