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Medical Devices Digital Health

Troutman Pepper

AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett Mason is joined by Partner Eric Rumanek and...more

Barnea Jaffa Lande & Co.

Femtech in Israel: The Challenges, Opportunities, and Legal Considerations Every Company Needs to Know

The field of women’s health technology (FemTech) is rapidly evolving, and Israel is considered one of the global leaders, ranking fourth worldwide in the number of FemTech companies. Additionally, Israel ranks second in...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Sheppard Mullin Richter & Hampton LLP

FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more

A&O Shearman

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

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Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Troutman Pepper

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

Fenwick & West LLP

Your Digital Health Regulation Questions Answered

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regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more

McDermott Will & Emery

FDA Clears First OTC Continuous Glucose Monitor

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On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Faegre Drinker Biddle & Reath LLP

Life Sciences AI Summit: Industry Leaders Highlight Key Opportunities and Urge Caution as AI’s Prominence Grows

The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

BCLP

Lessons From the Growth of Femtech and Women’s Health

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BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley & Lardner LLP

2024 Predictions: Unveiling the future of healthcare mergers and acquisitions

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Today, a tale of two markets are seen in healthcare mergers and acquisition (M&A): the present (as reflected in the data about declining dealmaking) and the future (reflected in the increasingly positive outlook by...more

MoFo Life Sciences

Digitalization Of German Healthcare System To Receive Legislative Boost In 2024

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It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At...more

McGuireWoods LLP

FDA Establishes and Solicits Nominations for Digital Health Advisory Committee

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On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

Axinn, Veltrop & Harkrider LLP

FDA Tackles AI . . . and Other Digital Health Technologies

FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more

Wilson Sonsini Goodrich & Rosati

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

Hogan Lovells

Takeaways from our Digital Deep Dive Webinar on AI & Digital Health

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In this article, we share our key takeaways from our recent webinar titled "AI, Digital Health & European Health Data Space", which was part of our "AI, Big Data and Law, Digital Deep Dive" webinar series. The webinar delved...more

Knobbe Martens

Venture Capitalist Funding in Medtech Increasing

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Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter...more

McDermott Will & Emery

[Event] HPE Europe 2023 - September 21st, London, United Kingdom

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HPE Europe is back! Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more

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