June 2024 - Page 2 of 4

June 26, 2024 Artificial Intelligence FDAcop

Peter Marks from CBER Discusses New Rare Disease Hub and Upcoming Guidance on Accelerated Approvals: An Exclusive Analysis in Life Science

I’m sorry, but I’m unable to provide a summary for the content as there isn’t enough detailed information available in your request to summarize it to 800 words. The text provided mentions Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), speaking at the Drug Information Association (DIA) annual meeting about a […]

June 26, 2024 Artificial Intelligence FDAcop

Unlocking Market Adoption: The Essential Guide

In a critical discussion on the Global Medical Device Podcast, hosted by Etienne Nichols, Shaherah Yancy, CEO of Research Lifecycle Solutions, shared her profound insights on key strategies for MedTech companies, particularly focusing on the importance of clinical and regulatory frameworks. Here’s a breakdown of their conversation and the valuable takeaways for anyone involved in […]

June 26, 2024 Artificial Intelligence FDAcop

Embecta Showcases Its Insulin Patch Pump at ADA Event

Embecta, a company previously known for manufacturing pen needles and insulin syringes, has made strides in the development of an insulin patch pump specifically designed for individuals with Type 2 diabetes. The company showcased two abstracts at the recent American Diabetes Association Scientific Sessions, which spotlighted the need and effectiveness of their new patch pump […]

June 25, 2024 Artificial Intelligence FDAcop

Grail Embarks Independently in the Public Markets Following Completion of Illumina Spin-Off

Cancer test maker Grail made its debut on the Nasdaq on Tuesday, marking a significant pivot nearly four years after its initial public offering plans were disrupted by a takeover from Illumina. This development follows a prolonged period of regulatory disputes involving both the U.S. Federal Trade Commission and the European Commission, which challenged the […]

June 25, 2024 Artificial Intelligence FDAcop

Managing Medical Device Projects with Paper Systems: A High-Risk Approach

Despite the prevalence of modern document management options, many startup medical device companies surprisingly still rely on traditional methods such as paper records and “digital paper” tools like spreadsheets, Dropbox, and other general-purpose software. These methods pose significant risks to both business operations and product quality within a Quality Management System (QMS). There are inherent […]

June 25, 2024 Artificial Intelligence FDAcop

Insulet aims to expand Omnipod 5 labeling to include Type 2 diabetes.

Insulet, a prominent player in the diabetes care sector, is actively seeking to broaden the use of its Omnipod 5 insulin pump to include individuals with Type 2 diabetes after its recent regulatory submission to the U.S. Food and Drug Administration (FDA). The move could significantly impact the treatment landscape for the 30 million Americans […]

June 25, 2024 Artificial Intelligence FDAcop

FDA completes plan to regulate certain laboratory-developed tests

The Food and Drug Administration (FDA) has announced that it will begin actively regulating tests developed in laboratories, with some exemptions. This decision comes after Congress failed to pass a law regulating these tests, which have grown in power and complexity over the years. The agency’s move is motivated by concerns about tests like Theranos’ […]

June 24, 2024 Artificial Intelligence FDAcop

Exclusive Article | Thank You

The Federal Food, Drug, and Cosmetic Act prohibits facilities from denying, delaying, or limiting FDA inspections, or their products may be considered adulterated. This policy has been in place for drug facilities since 2012, but was only extended to medical devices in 2017 under the FDA Reauthorization Act. The FDA has finalized a revision to […]

June 24, 2024 Artificial Intelligence FDAcop

Tracking Risky Medical Devices: How Kaiser Permanente Hospitals Stay Vigilant

When new medical devices are approved by the FDA, there is still uncertainty about their effectiveness. Unlike biotech products, device makers do not have to provide as much clinical data for approval. After approval, tracking device performance in the real world is challenging due to lack of comprehensive databases and difficulties in tracking unique device […]

June 24, 2024 Artificial Intelligence FDAcop

Roche Announces New Neuro Alliance, Signs R&D Agreement with RNA-Editing Startup Ascidian

Roche, a pharmaceutical company, has entered into a partnership with Ascidian Therapeutics, a startup focusing on RNA editing technology in genetic medicine. This $42 million deal allows Roche to use Ascidian’s RNA exon-editing technology for certain neurological targets that have severe unmet medical needs. Ascidian’s approach to genetic medicine involves editing exons to replace mutated […]

Month: June 2024