More than 1 million Class I medical device units recalled in Q1

By Medisi America on 18 junio, 2019

For the third consecutive quarter, more than one million Class I units were recalled during 2019’s Q1.

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Posted in News.

10 octubre, 2019

AI-enhanced ECGs may soon assess overall health

Scientists have trained an artificial intelligence tool to predict sex and estimate age from electrocardiogram readouts. They suggest that, with further development, the tool could soon be helping doctors to assess the overall health of their patients. An electrocardiogram, also known as an ECG or EKG, is a painless, simple test that records the electrical …
10 octubre, 2019

Medtronic announces Infuse spine trial

Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures. The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, …
24 agosto, 2020

COFEPRIS Evolves
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New York Times calls for tightened medical device regulation from FDA

The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use. If you want to read more about this news click here.

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