Podcast - Regulating AI in Healthcare: The Road Ahead
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Colorado AI Act — The Good Bot Podcast
AGG Talks: Healthcare Insights Podcast - Episode 8: What Healthcare Companies Need to Know When the Government Comes Knocking
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with Christine Vannais and Laurie Braxton of Fujifilm
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 1 — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 184: The Future of Healthcare Systems and AI with Alan Andress of Deloitte
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Episode 172: Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 170: Joel Gates, Senior Director of Operations for Azzur Cleanrooms on Demand
Health + Tech - Improving Cancer Care With Digital Health Tools
Health + Tech - Leveraging AI to Drive Growth
Turning Radiation Oncology Challenges into Solutions: Kurt Sysock's RADformation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 159: Bob Quinn, Executive Director, and Adrianne Grimes, Director of Marketing and Comms, SCRA
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional...more
Heather and Matthew welcome Dr. Gil Price, who has had an impressive career in the life sciences industry as a recently retired executive and currently serves as a board member for numerous companies. As an experienced leader...more
Antibody-drug conjugates (ADCs) are a promising class of cancer treatments with an accelerating number of U.S. Food and Drug Administration (FDA) approvals and rapidly growing market size, as discussed in previous articles in...more
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
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
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
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
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
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
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
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’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
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
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
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
On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more
The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more
From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more