Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 218: Artificial Intelligence in Drug Development with John Van Hoy of PPD & Thermo Fisher
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 215: Bioactives for Human Health with Jan-Willem van Klinken of Brightseed
Harnessing Generative AI: Innovations and Best Practices — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with Igor Jablokov of Pyron
The Evolving Landscape of Behavioral Health Transactions: Insights from Industry Professionals
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care
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 211: Cybersecurity and Privacy Risks for the Healthcare Industry with Brandon Robinson of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 210: Impacts of the Chevron Doctrine Ruling with Mark Moore and Michael Parente of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
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
Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
The CMS Interoperability and Prior Authorization Rules
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
When I was working on my Masters in data science, one of the projects I did was to create an algorithm that would take an intended use statement for a medical device and predict whether FDA would require a clinical trial. It...more
One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by...more
Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k). At a high level, I observe that on average clearance can take 160 days according to the data. Then, beyond that, I...more
Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit. The kit was developed for those who are unable to...more
ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The...more
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was supported by data collected from a...more
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more
It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA...more
The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough...more
This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more
On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat....more
Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive...more
The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. In keeping with...more
French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to capture and transmit injection data...more
When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its user fee obligations. For many averages,...more
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...more
On April 16, 2021, the Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15,...more