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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 143: Paul Sheils, CEO, Fluent
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
News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more
U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for...more
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...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 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
...It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient. Understanding...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
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...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
Nathan Downing presented on artificial intelligence in medical products and strategies for partnering with FDA at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California. If you do not...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...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
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...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
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...more
Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a “Breakthrough Device Designation” from the FDA....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