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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.
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