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 » Commercial Operations

Commercial Operations
Commercial Operations RSS Feed RSS

Omnipod Customers’ PHI Potentially Leaked

January 30, 2023

Insulet announced that it has emailed 29,000 Omnipod insulin pump customers to advise them that some of their personal health information (PHI) — but not financial, social security number, email or password — was inadvertently shared with Insulet’s website performance and marketing partners.

Read More

Notable Acquisitions in 2022 As Top Companies Expand Their Portfolios

January 13, 2023

Interventional devices for heart rhythm disorders and neurovascular care, device software and assays featured among the top buyout announcements of medical device companies in 2022 — led by the Johnson & Johnson (J&J) $16.6 billion Abiomed purchase.

Read More

SeaStar and Nuwellis Ink Licensing Deal for Acute Kidney Injury Device

January 3, 2023

The financial terms of the deal were not disclosed.

Read More

Olympus to Acquire AI Endoscopy Developer Odin Vision

December 29, 2022

The company aims to “create a paradigm shift in the way artificial intelligence is integrated into the endoscopy suite.”

Read More

Pfizer and Anumana Ink Multi-Year AI Electrocardiogram Algorithm Deal

December 19, 2022

Pfizer has entered into a multi-year deal with Anumana — a joint venture between the Mayo Clinic and nference, an electronic health record data company — to develop software for early detection of cardiac amyloidosis. 

Read More

Teva Sued for Allegedly Blocking Generic EpiPen and Narcolepsy Drug

December 7, 2022
In another class action lawsuit involving generic EpiPens, two individuals and a health insurer have filed against Teva Pharmaceutical for allegedly making a deal with Viatris for Teva to delay marketing of its generic EpiPen in exchange for Viatris holding off marketing its generic narcolepsy competitor to Teva’s Nuvigil. Read More

Large-Scale Trial Shows Lunit Breast Cancer AI More Accurate than Radiologist Reviews

November 29, 2022
Lunit’s study of 55,579 mammograms showed an increased cancer detection rate and a lower patient recall rate using the company’s Insight MMG breast cancer artificial (AI) solution than a team of two radiologists, the South Korea-headquartered company reported. Read More

HeartVista Teams With Siemens Healthineers for Cardiac MRI Exams

November 22, 2022
HeartVista has updated its software to allow users to combine its functions with those in the Siemens Healthineers MRI scanners. Read More

HeartVista, Siemens Healthineers Partner to Simplify Cardiac MRI Exams

November 21, 2022
California’s HeartVista has teamed with Germany-based Siemens Healthineers to co-market an automated cardiac magnetic resonance (CMR) imaging exam platform that takes up less scanner time and requires no additional training for technicians. Read More

Lantheus to Pay POINT Biopharma $260M for Two Late-Stage Cancer Treatments

November 16, 2022
Lantheus, which specializes in radiopharmaceutical diagnostic and therapeutic products, will pay $260 million in upfront license fees — with potential for another $1.8 billion — for worldwide rights to two of POINT Biopharma’s late-stage cancer therapeutic candidates. Read More

FDA Hands UFP Technologies a Form 483 for Cleanroom Controls, Other Lapses

November 15, 2022
The potential for cleanroom contamination and other deficiencies led to a Form 483 for UFP Technologies, following an FDA inspection of the company’s Chicopee, Mass. facility. Read More

WCG Imaging Among 2022 Top 10 Device Testing Companies

November 14, 2022
WCG Imaging has been named one of this year’s top 10 medical device testing and certification companies by MedTech Outlook, a medical technology publication. Read More
Previous 1 2 3 4 5 6 7 8 9 … 155 156 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