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Tag: fda

Kiosk Manufacturer Association – Vaccine Kiosks, Tradeshows and ADA News

DENVER, Aug. 18, 2021 /PRNewswire/ -- August news for the Kiosk Association. Trade Shows are back KMA is now an official media partner for InfoComm...

Two Day Course: Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers (September 16-17, 2021)

DUBLIN, Aug. 18, 2021 /PRNewswire/ -- The "Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers" training has been added to...

Mushrooms Company Levitee Labs Entered Canadian Securities Exchange

If you haven’t gotten the memo yet, medical psychedelics are the next big thing, and there are great reasons why, that mare made...

Inspira Technologies Reached Important Milestone as It Completed a Pump Bench Study

RA'ANANA, Israel, Aug. 18, 2021 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd (Nasdaq: IINN) (Nasdaq: IINNW) ("Inspira Technologies" or the "Company"), a specialty...

CardioNXT wins FDA nod for heart treatment delivery platform

  BOULDER, Colo., Aug. 18, 2021 /PRNewswire/ -- CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration...

A New Clinical Study To Evaluate The Effects of Cannabo-Nerve Combination On Chronic Neuropathic Pain

*** PRESS RELEASE *** San Francisco, CA – Herzliya, Israel, August 17, 2021 – Cannformatics, an early-stage biotechnology startup focused on the identification...

Abbott takes on competition with FDA approval of device to prevent afib-related strokes

Abbott Laboratories will go toe-to-toe with competitor Boston Scientific after getting approval from the Food and Drug Administration for a device intended to...

Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke

NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on...

Spectrum Solutions Receives Device FDA Emergency Use Authorization for Unsupervised Saliva Collection for COVID-19 Testing

Aug. 17, 2021 10:00 UTC SALT LAKE CITY--(BUSINESS WIRE)-- Spectrum Solutions, LLC today announced the U.S. Food and Drug Administration (FDA) has extended its...

Smith+Nephew expands its leading WEREWOLF™ Technology into total joint arthroplasty with launch of WEREWOLF FASTSEAL 6.0 Hemostasis Wand

LONDON, Aug. 17, 2021 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announces the launch of WEREWOLF FASTSEAL 6.0 Hemostasis...

Software Service Provider Qualification and Management

What is your company’s approach to qualifying a software service provider and managing software-as-a-service (SaaS) for cybersecurity? The need for qualifying and managing your software service provider Most of the productivity gains of the past decade are related to the integrartion of software tools into our business processes. In the past, software licenses were a […]

The post Software Service Provider Qualification and Management appeared first on Medical Device Academy.

Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.

Occlutech Holding AG announces the conditional U.S. Food and Drug Administration approval of its Investigational Device Exemption application to conduct a pivotal study,...

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