News & Analysis as of

Life Sciences Health Technology Medical Devices

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

Foley & Lardner LLP

HSBC Venture Healthcare Report: 1H 2024

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For a succinct analysis of 1H 2024 venture investment and exit activity in life sciences and health care, take a look at HSBC’s Venture Healthcare Report, Shake it off: HSBC Innovation Banking Analysis, 1H 2024. Lead author...more

Knobbe Martens

Florida Man Makes Medical Device – A Survey of MedTech in the Sunshine State

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Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota, and Massachusetts.  It was...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

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Knobbe Martens

3M Spins Off Healthcare Business Solventum

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3M recently completed the spinoff of its healthcare technology business as the new standalone public company, Solventum Corporation.  Solventum has an IP portfolio with over 7,300 patents globally....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

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...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

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

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

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

McGuireWoods LLP

Health + Tech - Improving Cancer Care With Digital Health Tools

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Jessica Thurmond and Monica Schmiede, co-CEOs and co-founders of Athelo Health — the first biometric-anchored virtual coach for women with breast and gynecologic cancers — join McGuireWoods partner Kristen McDermott Woodrum...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

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

McDermott Will & Emery

Top Takeaways | 2023 Digital Health Forum | Innovative Partnerships in Action: Fireside Chat with Best Buy and Atrium Health, a...

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In this lively and practical conversation, panelists elaborated on the recently announced partnership between Atrium Health, a part of Advocate Health (Atrium), and Best Buy Health. The partnership is designed to leverage...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Hogan Lovells

The next era of digital therapeutics

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Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more

Hogan Lovells

FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in...

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In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope of the FDA’s oversight...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

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The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - August 2021: RHC Recommendations for the Reform of Medical Devices Regulation

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On 19 August 2021, the Regulatory Horizons Council (the “RHC”) published a report setting out recommendations for reforming the regulation of medical devices in the UK (the “Report”). The RHC is an independent expert...more

Morgan Lewis

China Amends Regulation Governing Medical Devices

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China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more

Hogan Lovells

First steps towards taking into account the organizational impacts of health care technologies

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On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance...more

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