False Compliance with CISPR 11 Ends in $12 Million Company Fine
Take it from Advanced Bionics. If you’re going to use CISPR 11 to support findings in pre-market applications, it better be correct.
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Continue Reading »The Bumpy Road to EU Medical Device Regulation (MDR)
The European Union’s Medical Device Regulation (MDR) transition has been extended to avoid critical medical device shortage.
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Continue Reading »Roadblocks Still Exist in Transition to IVD Regulation
It is indisputable that the amending Regulation (EU) 2022/112, which extended the IVD Regulation’s transitional provisions, brought significant relief and protected patients, laboratories and healthcare systems from immediate shortages of needed IVD medical tests. Around 21% of today’s total IVD market is already certified under the IVDR. This represents a three-fold increase compared to July 2021.
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Continue Reading »Are Supply Chain Pressures Easing for Medtech?
Here’s what GE Healthcare, Stryker, Abbott, Boston Scientific, and Intuitive Surgical expects in terms of the global supply chain in 2023.
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Continue Reading »Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke
Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke – read this article along with other careers information, tips and advice on BioSpace…
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Continue Reading »Pentax Kicks Off 2023 with CE Mark Approvals
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Continue Reading »Asensus Surgical Receives CE Mark for Expanded Machine Vision Capabilities
Asensus Surgical Receives CE Mark for Expanded Machine Vision Capabilities – read this article along with other careers information, tips and advice on BioSpace…
Read the full article at: www.biospace.com
Continue Reading »New tool uses ultrasound ‘tornado’ to break down blood clots
Researchers have developed a new tool and technique that uses ‘vortex ultrasound’ — a sort of ultrasonic tornado — to break down blood clots in the brain. The new approach worked more quickly than existing techniques to eliminate clots formed in an in vitro model of cerebral venous sinus…
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Continue Reading »5 medtech trends to expect in 2023
Bernard Ross, CEO and Founder of Sky Medical Technology, shares his views on the direction of travel of the healthcare industry looking to 2023 and beyond, and the role medical technology (medtech) will play.
Read the full article at: www.todaysmedicaldevelopments.com
Continue Reading »Some hospitalized patients’ infections may develop from their own bacteria: Study in mice indicates medical interventions can awaken dormant, hidden bacteria
The opportunistic bacterium Acinetobacter baumannii rarely sickens healthy people but causes serious infections in hospitalized patients. A study in mice suggests that Acinetobacter can hide undetected in bladder cells and then reactivate when stimulated by medical intervention.
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