We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Topics » Devices » Submissions and Approvals

Submissions and Approvals
Submissions and Approvals RSS Feed RSS

Tyber Medical Anatomical Plating System Gains Expanded Clearance

March 22, 2023

Tyber Medical’s anatomical plating system first received 510(k) clearance in 2020.

Read More

Implantable Sleeve that Holds Spinal Screws in Place Gets FDA Clearance

March 22, 2023

The off-the-shelf device can be deployed in under two minutes and is similar to drywall anchors, the company said.

Read More

Accelus Remi Robotic System Cleared for Use with GE Imaging System

March 21, 2023

Initial surgeries with the Remi 2D system are expected to begin in July.

Read More

BD’s COR System Cleared for Detecting Three Causes of Vaginitis

March 20, 2023

Four out of 10 women don’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which leads to additional visits because of persistent symptoms, the company said. 

Read More

Cotras Gets FDA Approval of Virtual Reality Rehab Device

March 20, 2023

The device supports aging-in-place by enabling patients to regain mobility and function.

Read More

Device Labeling Must Include Any New Intended Uses

March 17, 2023

Among the many requirements to bring your product to market is to have accurate labeling — as well as procedures in place to ensure that and any new intended uses are included.

Read More

Visby Medical STI Test gets FDA Clearance

March 17, 2023

The test can be used in CLIA-waived point-of-care settings.

Read More

TytoCare AI Home Wheeze Detection Device gets FDA Clearance

March 17, 2023

The decision support software previously gained CE mark certification.

Read More

Prolira’s Beside EEG Monitor Cleared for Acute Brain Failure

March 17, 2023

Up to 88 percent of acute brain failure cases are missed, the company said.

Read More

Visby Medical’s 30-Minute STI Test gets FDA Clearance

March 16, 2023

Visby Medical’s in-office test for sexually-transmitted infections (STIs) in women that delivers 97 percent accurate results in 30 minutes — not the usual two to five days with laboratory testing — just received FDA clearance, enabling diagnosis and treatment in the same office visit.

Read More

Bausch Health Gains PMA for Cataract Surgery Ophthalmic Device

March 16, 2023

The product’s viscosity offers structural stability in the eye and creates space in the chamber during surgery.

Read More

LivaNova’s Heart-Lung Machine Cleared for Use in Perfusion System

March 15, 2023

The Essenz system can also be integrated with operating room external devices and hospital information systems, the company said.

Read More
Previous 1 2 3 4 5 6 7 8 9 … 424 425 Next

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Advamedica’s Hemostat Cleared for Severe Surgical Bleeding

  • FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

  • Wesper Next-Generation Device Cleared for Sleep Test Data Collection

  • FDA Approves First-Ever Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

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