Elizabeth Orr on Muck Rack

Elizabeth Orr

Verified
Arlington
As seen in: Medtech Insight, Wiley Online Library, Taylor & Francis Online, Bristol University Press and Policy Press, Citeline, Generics Bulletin, HBW Insight, In Vivo, The Pink Sheet, Hill Country Community Journal, AGU's Eos
Managing editor of policy & regulation for @Medtech_Insight at @pharma_intell. Any opinions are my own; RTs do not equal endorsement.
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Articles

FDA Breakthrough Device Data Shows Surge In Diagnostic Designations

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By Elizabeth Orr 
| Citeline
Updated breakthrough device program data released by the US FDA on June 5 show a jump in the number of diagnostics accepted to the program, the level of new designations holding steady, and the persistence of the so-called “valley of death” that separates designation from marketing authorization. The diagnostics sector showed the greatest level of new designations in new breakthrough device program data from the US FDA.
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Five Product Types Added To FDA List Of 510(k)-Exempt Devices

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By Elizabeth Orr 
| Citeline
The US FDA has updated its list of pre-amendment devices that are exempt from 510(k) requirements to include five new product types, including eye cups, acupressure devices and prosthetic nails. Acupressure wristbands to combat nausea are among the five device types now exempt from 510(k) requirements.
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Nuwellis Push To Expand Aquadex Pediatric Use Backed By Real-World Evidence

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By Elizabeth Orr 
| Citeline
Nuwellis is using real-world data to seek FDA clearance for Aquadex use in infants as small as 5kg, extending the fluid management device below its current 20kg threshold. The FDA's evolving real-world evidence framework has opened a more practical path for pediatric indications, the company said. Nuwellis is pursuing FDA clearance for use of its Aquadex fluid removal system in children as small as 5kg.
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