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United States

Set Alert for Policy and Regulation United States

US, UK And Canada Collaborate On Transparency Principles For Devices Using Machine Learning

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

FDA Regulation

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development

Physician And myTomorrows CEO Discusses FDA’s New Program To Advance Clinical Trial Diversity

The US FDA recently announced a new initiative aimed at improving access to cancer trials among traditionally underserved populations. myTomorrows CEO Michel van Harten talked to Medtech Insight about how the agency’s plan might reshape the landscape of clinical trials going forward.

FDA Clinical Trials

What’s New In Digital Therapeutics? Investment Strategies, Reimbursement And More From DTA Annual Summit Day 1

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

DTA Digital Health

Expert: Which AI Standard Is The Gold Standard?

When looking for a standard for AI development, expert Eric Henry recommends turning to the tried-and-true Standard Delivery Organizations (SDOs).

Artificial Intelligence Regulation

Abbott’s Lingo Becomes Second FDA-Cleared OTC Blood Glucose Monitor

The FDA has given the green light to over-the-counter sales of Abbott’s Lingo blood glucose monitoring device, which is intended for use by healthy people who want to track the crucial biomarker.

Approvals FDA

Zeto Wins FDA Clearance For Novel Seizure Detection Device

The US FDA has granted 510(k) clearance to a California medical technology company for a brain monitoring device that detects seizures in patients with brain injury or trauma.

FDA Innovation

Global Medtech Guidance Tracker: May 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.

International Guidance Documents

Warning Letters – May 2024

The US Food and Drug Administration released five warning letters last month, showing an ongoing focus on premarket clearance and the quality system regulations compliance.

FDA Warning Letters

FDA Implements Authority To Destroy Certain Medical Devices, Amends Final Rule To Provide Device Owners Prior Notification

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

FDA Enforcement

Expert: FDA Missed Opportunity For Software In Remanufacturing Guidance

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

Guidance Documents Regulation

‘Tremendous Potential’: David McMullen Discusses FDA Perspective On Mental Health Apps

US FDA neurological device office head David McMullen is watching digital health tools make mental health treatments more widely available than ever before, though the expansion comes with some risks. Medtech Insight spoke with him about the FDA’s role in this growing field.

FDA Digital Health

Synthetic Data Has A Future As A Regulatory Science Tool, OSEL Director Says

The director of the US FDA’s Office of Science and Engineering Laboratories said there’s a future for synthetic datasets in the Regulatory Science Tools catalog.

FDA Regulation

Q-Sub Guidance Needs Clarity On Informal Meetings And Timelines, Say Commenters

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

FDA Guidance Documents

NAD Oddball: Thermometer Case Administratively Closed As Advertiser Takes Matter To Federal Court

Exergen seeks a declaration from Massachusetts federal court that claims challenged by Baxter in the National Advertising Division forum regarding the accuracy of its thermometers do not constitute false or misleading advertising, if they are even advertising at all.

Advertising, Marketing & Sales Legal Issues
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