BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • BCI
    • Ebola outbreak
    • Hantavirus
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Tuesday, June 30, 2026
View BioWorld MedTech
Home » FDA posts OUS device warnings as U.S. company receives second warning in three years
To read the full story, subscribe or sign in.

FDA posts OUS device warnings as U.S. company receives second warning in three years

April 9, 2020
By Mark McCarty
The FDA’s device center has resumed a more normal pace of warning letter issuance in recent months, and the latest batch posted to the warning letter website features warning letters to one device maker in Europe and three firms in Asia. One U.S. firm, Steiner Biotechnology LLC, of Henderson, Nev., also received a warning, however, which is the second the company has received since June 2017.
Medical technology Regulatory FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 29, 2026.
  • Illustration for mutations in the DNA leading to brain diseases or neurodegenerative disorders

    ENCALS 2026: From genetics to advancing strategies against ALS

    BioWorld Science
    Amyotrophic lateral sclerosis (ALS)-associated genes provide direct therapeutic targets and reveal pathways that can be used to develop treatments that counteract...
  • Subsense BCI platform

    Next wave of BCI firms builds on pioneers to tackle challenges

    BioWorld
    With the pace of neurotechnology development accelerating, a wave of brain-computer interface (BCI) companies is emerging on the heels of the pioneers. In the...
  • Handshake with DNA, molecules

    Elixirgen and Nippon Shinyaku sign EXG-7001 option agreement

    BioWorld Science
    Elixirgen Therapeutics Inc. has entered into an option agreement with Nippon Shinyaku Co. Ltd. for the development and commercialization of EXG-7001 for Duchenne...
  • Digital brain with dollar sign

    Investors bet on transformative BCI tech for neuro disorders

    BioWorld
    An estimated $2 billion has been invested in the brain-computer interface (BCI) space in the last two years and the level of funding is expected to continue....
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing