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Set Alert for Policy and Regulation United States

New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

Guidance Documents FDA

Digital Health Center Of Excellence Publishes Policy FAQs

The DHCoE’s new page provides a one-stop-shop for frequently asked digital health policy questions.

Digital Health FDA

Federal Court Rejects Motion To Dismiss Case In Genomics Patent Infringement Suit

Parse Biosciences’ motion to dismiss a patent infringement case has been rejected by a US District Court.

Legal Issues Intellectual Property

Califf Hires New US FDA Senior Advisor, But Duties Seem Vague

As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.

FDA Leadership

AdvaMed Proposes Comprehensive Strategy for CMS To Encourage Access to AI and Software

AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.

Medicare Regulation

Akili Turns Heel, Goes ‘All In’ On OTC Model For ADHD Digital Therapeutics

The Boston, MA-based company says the pivot away from Rx will enable it to pursue a significantly larger market and remove “key friction points” that have prevented patients from accessing its game-based digital ADHD treatment. The company is targeting year-over-year cost savings of $8m-$18m after investments to juice up its direct digital marketing program.

Commercial Business Strategies

FDA Updates Breakthrough Devices Guidance To Improve Health Equity

The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.

FDA Policy

GAO Report Highlights Concerns About Device Advertising

The US Government Accountability Office spoke to 11 stakeholder groups about potential trouble spots in FDA and FTC supervision of consumer ads for medical devices. 

Advertising, Marketing & Sales Regulation

Class I Recall For Abbott Implantable Pulse Generators

Abbott Medical has recalled several models of its implantable pulse generators (IPGs).  The devices are part of the company’s Proclaim neurostimulation systems, which deliver low-intensity electrical impulses to nerve structures.

FDA Regulation

PTAB Affirms Previous Decision In Favor Of Apple In Masimo Patent Case

A new decision from the PTAB upholds prior rulings rejecting four of Masimo’s appeals and reverses a decision on one.

Regulation Legal Issues

CMS Promises Actions To Support TCET Pathway

CMS has released a list of actions and guidance documents it plans to take to support the TCET pathway.

Medicare Medicaid

FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body

The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.

FDA Guidance Documents

FDA Data: Breakthrough Program Accepted 45% Of Applicants Since 2015

Data from the US Food and Drug Administration shows that the agency has granted 853 breakthrough device applications since 2015, out of 1,909 applications. The acceptance rate has varied from 33% in 2016 to 72% in 2017, with acceptance rates in recent years hovering around the 40% mark.

Regulation FDA

Q&A Guidance Clarifies Human Factors Testing For Combination Products

A highly anticipated final guidance from the FDA on Human Factor Studies answers frequently asked questions about human factor studies when designing combination products. 

Guidance Documents Regulation

Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

FDA Regulation

Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

Digital Health Diagnostics
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