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Blue Goat Cyber Sponsors Devicetalks Minnesota Jordan John To Share FDA Cybersecurity Strategies
Mastering FDA Cybersecurity Blue Goat Cyber joins DeviceTalks Minnesota to showcase expert strategies for FDA-rea ...
Asianet Newsable on MSN4h
ReShape Lifesciences Stock Soars On Regulatory Certification For Medical Devices In EU, UK: Retail Eyes Fair Valuation
ReShape CEO Paul F. Hickey said that the company achieved MDR and UKCA certification “well in advance” of the Dec. 31, 2027, ...
US FDA launches AI tool to reduce time taken for scientific reviews
The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving ...
MedTech Dive4h
FDA declines to appeal court order that stopped LDT final rule
The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...
FDA’s early AI debut sparks questions
The FDA launched an artificial intelligence tool Monday dubbed Elsa, with Commissioner Marty Makary hyping the effort’s early ...
Newseria BIZNES11h
MSCopilot® receives CE marking under the European Union Medical Device Regulation (EU MDR) 2017/745
On the occasion of World Multiple Sclerosis Day, Ad Scientiam announced that MSCopilot ®, its class IIa Software as a Medical Device (SaMD) dedicated to the monitoring of people living with multiple ...
STAT21h
FDA rolls out AI tool agency-wide, weeks ahead of schedule
The FDA rolled out its agency-wide AI tool weeks ahead of schedule, on Monday offering a look at the technology and how it ...