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FDA Roundup: May 31, 2024

FDA Roundup: May 31, 2024
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.

United statesEli lillyHealth data in medical device developmentAutonomous medical systems saams collaborative communityOffice of media affairsDrug administrationModerna modernatx incPilot programOpenoximetry collaborative communityJuno therapeutics incDigital medicine societyComputer interface collaborative communityCenters for medicare medicaid servicesCenters for diseaseRespiratory syncytial virus vaccineSafeguarding therapeutics act

ISPOR Panel Explains CMS Pathway to Cover New Technology

ISPOR Panel Explains CMS Pathway to Cover New Technology
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United statesRenee arnoldPeter neumannDouglas kellyRubix healthNational institutes of healthHealth forumSociety for health economicsOutcomes researchTufts medical centerAdvisory programA health technology assessment organizationTransitional coverageEmerging technologiesRegulatory pathwaysReal world evidence

Blue Arbor wins FDA breakthrough nod for neuromuscular interface

Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system.

Paul cedernaAdvisory programBlue arbor technologiesTotal product life cycleMichigan based blue arborBlue arbor restoreHarbor technologiesBlue arbor

FDA s New Draft Guidance on Cybersecurity | Gardner Law

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing.

Brynn stanleySoftware bill of materialsDrug administration staffA secure product development frameworkProduct development frameworkFederal register noticeTotal product life cycleDesign controlsQuality management systemSoftware billDevice exemptionsMedical devicesQuality system considerationsPremarket submissions draft guidanceDrug administrationSecure product development framework

How Will Advanced Computing Technologies Catapult Medtech Into The Future

There is an almost unlimited profit potential for medtech manufacturers to use advanced computing technologies such as AI, faster and smaller.

United statesAptar pharmaElliot turriniElliott turriniBen locwinPierre leurentHarvard business school professor clayton christensenHealth canadaRegulatory agencyImprove existingSparrow therapy systemPatient controllerClinician programming appGood machine learning practiceMedical device developmentDisciplinary expertise is leveraged throughout

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