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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.

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American
Eli-lilly
Health-data-in-medical-device-development
Autonomous-medical-systems-saams-collaborative-community
Office-of-media-affairs
Drug-administration
Moderna-modernatx-inc
Pilot-program
Openoximetry-collaborative-community
Juno-therapeutics-inc
Digital-medicine-society

ISPOR Panel Explains CMS Pathway to Cover New Technology

ISPOR Panel Explains CMS Pathway to Cover New Technology
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Atlanta
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Health-forum
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Outcomes-research
Tufts-medical-center

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.

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Advisory-program
Blue-arbor-technologies
Total-product-life-cycle
Michigan-based-blue-arbor
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Harbor-technologies
Blue-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FDA's New Draft Guidance on Cybersecurity | Gardner Law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 In April of this year, the Agency released the latest draft guidance addressing.

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Software-bill-of-materials
Drug-administration-staff
A-secure-product-development-framework
Product-development-framework
Federal-register-notice
Total-product-life-cycle
Design-controls
Quality-management-system
Software-bill
Device-exemptions
Medical-devices

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.

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Canada
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Elliott-turrini
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Regulatory-agency
Improve-existing
Sparrow-therapy-system

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