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Innovation Food and Drug Administration (FDA) Medical Devices

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

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

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Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...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

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

Knobbe Martens

FDA to Collaborate with Veterans group on Medical Device Innovation

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On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help...more

Faegre Drinker Biddle & Reath LLP

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2021

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The pace of impact through digital health in 2021 is off to a rapid start—be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated...more

Womble Bond Dickinson

The Future is Digital Healthcare

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The use of digital technologies has accelerated almost overnight due to the COVID-19 pandemic, with healthcare providers and patients finding new and innovative, socially-distanced ways to deliver and receive services. This...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report: Summer 2020

The latest issue of The Life Sciences Report features an interview with Matthew J. Meyer, the firm's chief client corporate development officer, who has broad management experience in the life sciences sector; a piece...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Patrick Malone & Associates P.C. | DC Injury...

FDA reviews go faster — but with less proof drugs are safer or more effective

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more

McDermott Will & Emery

Disrupting Healthcare – Constructively: Considerations for Executing Innovation

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The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare...more

McDermott Will & Emery

Collaborative Transformation - Focus on Innovation Centers - Key Considerations for Investments in Entities Developing Innovative...

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Digital health and other life sciences/tech developers, particularly those producing innovative new solutions, offer dynamic opportunities for investors, in part due to the continued evolution of the US Food and Drug...more

Stinson LLP

FDA Introduces Safer Technologies Program for Medical Devices

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On September 19, FDA issued a draft guidance that continues its trend to incentivize innovation and increase collaboration with industries in order to expedite the premarket review process, the “Safer Technologies Program for...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

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Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

Holland & Knight LLP

Left to Their Own Devices: Administration, FDA Turn to Medical Device Innovation

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• Masked by the recent high-profile drug pricing debate has been the Trump Administration's discussions about the development, approval and reimbursement of medical devices. Recent comments by Administration leaders, as well...more

Troutman Pepper

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

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A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

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It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Knobbe Martens

The FDA's Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

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On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more

Knobbe Martens

First Thrombectomy Device Cleared for Pulmonary Embolisms

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The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment...more

K&L Gates LLP

Recent FDA Steps to Advance Medical Device Access and Innovation

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On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to advancing medical device access and innovation by stating, “[o]ur goal is to...more

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