All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Biosimilars
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Radiopharmaceuticals
    • Science '22 in Review
    • Top Biopharma Trends of 2022
    • Top Med-tech Trends of 2022
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • sign in
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, June 8, 2023
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
Regulatory, BioWorld MedTech RSS Feed RSS

Regulatory actions for June 7, 2023

June 7, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Teleflex.
Read More

FDA warning letters hint that med-tech compliance programs drifted during COVID

June 7, 2023
By Mark McCarty
No Comments
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
Read More
Map of Europe, France filled in with French flag

Committee set up in France to assess diagnostic, prognostic and predictive technology

June 7, 2023
By Bernard Banga
No Comments
The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
Read More
Smartphone displaying Stethophone app

Sparrow’s smartphone stethoscope gets FDA nod

June 7, 2023
By Meg Bryant
No Comments
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
Read More

Regulatory actions for June 6, 2023

June 6, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medical Solutions, Artelon, Avatar Medical, Deepx Diagnostics.
Read More

Regulatory actions for June 5, 2023

June 5, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Masimo, Sparrow Bioacoustics.
Read More

Abiomed’s fix for purge issues in some Impella 5.5 units falters

June 5, 2023
By Mark McCarty
No Comments
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.
Read More

Regulatory actions for June 2, 2023

June 2, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armis.
Read More

Sea-Long Medical says FDA inspection ‘a good learning experience’

June 2, 2023
By Mark McCarty
No Comments
U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.
Read More
digital health

China ramps up efforts to digitize health

June 2, 2023
By Alfred Romann
No Comments
China continues to ramp up efforts to digitize its health care system, as it moves closer toward a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow significantly over the next decade.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 286 287 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 7, 2023.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 7, 2023.
  • Medical cannabis in blister pack of capsules

    Zelira’s stock triples as cannabinoid outperforms Lyrica in pain

    BioWorld
    Medicinal cannabis company Zelira Therapeutics Ltd.’s stock shot up 224% on May 31 on the heels of news that its cannabinoid product, ZLT-L-007, outperformed...
  • Cerebellum, brain stem, spinal cord

    Reprocell reports mixed results for phase II Stemchymal trial in spinocerebellar ataxia

    BioWorld
    Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II...
  • EU flag, pills, syringe

    Otsuka’s schizophrenia drug filing U-turn amongst latest CHMP announcements

    BioWorld
    Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia,...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing