If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
The FDA has extended by two years key requirements related to its new unique device identifiers (UDI)—a move that amounts to a tacit acknowledgement that adoption and implementation of that tracking system for medical devices is more challenging than originally anticipated, according to the Association for the Advancement of Medical Instrumentation.
In the July 17 edition of the Weekly Jolt, we covered the FDA’s new proposed rule that would require most medical devices distributed in the United Stat
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Jeff Kabachinski, MS-T, BS-ETE, MCNE You have probably seen those funny-looking checkerboard blocks that are showing up all over the place these days. They are called QR codes or Quick Response codes—similar to the more common ba
Read MoreToshiba America Medical Systems Inc, Tustin, Calif, a developer of contrast-free magnetic resonance angiography techniques, has introduced time and space angiography, a fourth generation contrast-free imaging technique.
Read MoreGE donates intensive care monitoring system to college; FDA orders the seizure of unsafe hospital beds; Medrad Inc sales revenues grow; and more. GE Gives Lift to Biomed Tech Program GE Healthcare (Waukesha, Wis) has donated a complete inte
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Read MoreThe board of directors of the American College of Clinical Engineers (ACCE) believed that a nonprofit foundation would enable ACCE to reach professional goals and build upon the clinical engineering field’s foundation. ACCE created an exp
Read MoreFDA Releases Guidance, GE Receives Regulatory Approval for Instrumentarium, ECRI Evaluates Sharps Disposal Containers FDA Releases Guidance On August 19th, the US Food and Drug Administration issued a guidance for industry and FDA staff tit
Read MoreInstrumentarium closes on Spacelabs Medical Instrumentarium Corp. (Helsinki, Finland) on July 4 closed on its acquisition of Spacelabs Medical Inc. (Redmond, Wash.), paying $14.25 in cash per share to Spacelabs’ stockholders. Total value
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