Search Results for: recall

ECRI Institute Research Underpins FDA Medical Device Servicing Report

ECRI Institute has provided conclusive research to help guide the U.S. FDA in its new report, FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. The report concurs with ECRI Institute recommendations that additional regulatory requirements regarding the servicing of medical equipment by entities other than OEMs are not necessary.

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Global Infusion Pumps Market on the Rise

A new MarketsandMarkets report found that the global infusion pump market is expected to grow at a compound annual growth rate of 6% from 2018 to 2023, surging from its current $11.9 billion valuation to $15.89 billion. The increasing prevalence of chronic diseases, along with the rapid growth in the geriatric population, are driving market demand.

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Test Time: The Latest in Biomedical Test Products

It’s one of the biggest challenges biomeds face: The relentless need for medical device testing—for ensuring that everything is working as intended in order to guarantee the highest standards of patient care. With that in mind, we reached out to three biomedical test product companies and asked them about their latest innovations and how they might help HTM teams do their jobs. Here’s what they told us.

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FDA Publishes New Draft Guidance Regarding Product Recalls

U.S. FDA Commissioner Scott Gottlieb, MD, announced that the agency has developed new policy steps for strengthening product recalls. Specifically, Gottlieb revealed, the FDA has published a draft guidance that better explains the FDA’s policy on public warnings and device recall notifications—in an effort to provide more timely information to consumers.

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