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On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.

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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 Digital Health Center of Excellence, implementing predetermined change control plans, and issuing various digital health guidances on device software functions, clinical decision support software, cybersecurity, and other topics. In anticipation of FDA’s Artificial Intelligence /Machine Learning (AI/ML) Medical Devices Workshop in October 2021, we posted a brief history of the agency’s regulatory oversight of software through the traditional medical device regulatory framework established in the 1970s, in which we highlighted the numerous challenges associated with such an approach. But now, with the rise of artificial intelligence and machine learning and the proliferation of AI/ML-enabled software throughout the health care industry, FDA is facing enormous challenges using an outdated, procrustean regulatory framework to maintain standards of safety and quality for such software devices. It is becoming increasingly clear that innovation in the AI/ML and digital health technology space is advancing rapidly, as FDA Commissioner Rob Califf has emphasized in many recent public appearances, and that the traditional device framework is quickly becoming unworkable for such technologies.

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Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

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Reverse mergers aren’t an alternative to an IPO, rather they can be a strategic approach for companies looking to go public by leveraging “fallen angels”. Mintz Members Bill Hicks and John Rudy answer frequently asked questions for private companies considering a reverse merger in an article featured in PitchBook’s 2023 Annual US VC Valuations Report. The authors detail the benefits and challenges associated with a reverse merger including finding partners, PIPE financing, Nasdaq access for non-US companies, and SEC implications.

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J.P. Morgan Healthcare Conference (JPM) is one of the industry’s most important life science investment conferences of the year. Learn more about Cheryl Reicin's top five takeaways from the event.

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A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that the agency take urgent action to address pulse oximeter inaccuracies that continue to create health care risks for people of color. The letter comes exactly one year after a public meeting held by the Anesthesiology and Respiratory Therapy Devices Panel of the FDA’s Medical Devices Advisory Committee titled “Pulse Oximeter Accuracy and Limitations,” and nearly 21 months after the agency issued a safety communication about pulse oximeter inaccuracies when used on people with dark skin pigmentation (see our previous blog post on pulse oximeter performance here).

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The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are developing software aimed at health care systems, hospitals, physicians, and lay-users for various levels of use, from assisting diagnoses in a clinical environment to tracking exercise and general health indicators in the home. In particular, a growing number of companies is focusing on the development of digital therapeutics - a class of software devices that deliver and monitor medical interventions for the purpose of treating, managing, or preventing certain diseases or conditions - for use in a patient’s home. With all of the new players jumping into the digital health technology game, we thought it might be useful to provide a brief primer on certain factors to consider when evaluating the potential regulatory requirements for such products.

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The Centers for Medicare & Medicaid Services recently released the first 10 drugs included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Mintz Member Theresa Carnegie and Of Counsel Lauren Moldawer discuss the program, implications for drug manufacturers, and early lawsuits brought by drugmakers.

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Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application.

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Intellectual Property Viewpoints Thumbnail

At its heart, a patent grants the right to stop another person from doing whatever falls within the scope of the patent’s claims. A patent is not a right to practice what is included in the patent, or a government stamp of approval on everything within the scope of its claims.

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Turning innovation into a successful business can be daunting. In a panel discussion at the BIO International Convention, Mintz’s Josh Fox, who is a Member in our Chambers-ranked Life Sciences practice, alongside Massachusetts Institute of Technology (MIT) professors Robert Langer, Angela Koehler, and Giovanni Traverso, examined the challenges associated with spinning out  innovations from academic and research institutions, including how to build a team to run a new company and how to fund startups, particularly those that may not attract traditional venture capital easily (or at all). Here are their five key takeaways.

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The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests (LDTs) intended to support patient selection for such drugs. Although the pilot is limited to only nine participants, it is unclear based on the requirements of the program whether it will generate sufficient interest among oncology product sponsors to meet the objectives that the agency has established for it.

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Mintz welcomed investors and entrepreneurs from the Canadian and US life sciences ecosystem to our first annual matchmaking event in Toronto. In this video, hear about cross-border considerations for the sector and how Mintz’s life sciences focus positions us to guide emerging growth companies and investors doing business in both countries.

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The Center for Devices and Radiological Health (CDRH), the section of the Food and Drug Administration (FDA) responsible for the regulation of medical devices, has issued a request for public comments on expanding patient access to medical technologies intended for use by patients in their homes.

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Amid a tough equity market and an ebb in investment in the biotech sector, early- or growth-stage companies focused on drug discovery and development may want to spend some time exploring strategic partnerships with other businesses at the 2023 BIO International Convention.

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The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their upcoming integration into multiple Internet search engines. This development creates exciting opportunities and potentially terrifying risks in the health care space. Inevitably, people will ask AI chatbot-enabled search engines for information on diseases, conditions, medicines, or medical devices and use the response in some way to make certain medical decisions. But what happens when the AI chatbot’s response is inaccurate or even provides advice that may lead to harm if the user follows it? Can AI chatbots be regulated by the U.S. Food and Drug Administration (FDA)? What are the liability implications if a user is harmed? We provide some initial thoughts on such legal issues in this post.

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There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.

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Mintz represented CXL Ophthalmics (CXLO), a clinical-stage company developing a minimally-invasive treatment for keratoconus, in a $32 million Series A round of fundraising.

Health Care Viewpoints Thumbnail

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human Service’s declaration of a public health emergency under Section 564 of the Food, Drug and Cosmetic Act on August 9, 2022. Subsequently, the Secretary declared on September 7 that in vitro diagnostics for monkeypox were needed to respond to the public health emergency, and the FDA released its guidance on the same day. The monkeypox test guidance describes the agency’s general expectations and approach for test development and validation, as well as the EUA request process.

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