Josh Levin

AI warning letters. Cybersecurity deficiencies. Real-world evidence debates. FDA’s ELSA rollout. This week’s TTKU covered a lot. Allison Komiyama and Michael Nilo are joined by former FDA reviewer and current precision medicine regulatory expert Josh Levin to unpack the latest developments across medical devices, diagnostics, AI, and regulatory policy. The team dives into FDA’s newest De Novo authorizations, including the AurieSystem reusable catheter platform and a home HPV collection device designed to expand access to cervical cancer screening. Josh shares insights from the latest AMDM meeting, including why FDA reviewers are repeatedly flagging “cybersecurity, cybersecurity, cybersecurity” as a major issue for IVD companies. The group also discusses MDIC’s latest work around real-world evidence, pediatric device development, and the ongoing challenge of balancing innovation with data quality expectations. Other topics include: FDA’s new ELSA 4.0 AI rollout HALO platform consolidation QMSR inspection growing pains FDA’s one-day inspection pilot Precision medicine & companion diagnostics Why FDA hiring restrictions may hurt reviewer recruitment ELP program applications reopening New guidance on patient-matched orthopedic implant guides Links FDA ELSA 4.0 Announcement FDA eSTAR Program Update (new FAQs) FDA One-Day Inspection Pilot FDA Guidance: Patient-Matched Guides for Orthopedic Implants Connect Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health Michael Nilo, MS | Nilo Medical Consulting Group Josh Levin | IronLine Consulting , GSK Subscribe Sign up to receive a calendar invite for weekly TTKU sessions

Hello, media consumers! Bryan is still out on vacation, but Joel is here with two former colleagues, Josh Levin and Stefan Fatsis. They kick off the show by discussing the first time Joel joined them on a podcast (0:44). Then they discuss the following: ‘Hang Up and Listen,’ a sports show that was produced by a non-sports publication (14:00) The reason Josh and Stefan hate the Hall of Fame (28:34) Josh and Bryan’s "mutually reinforcing weirdo tendencies" (32:01) How covering sports for ‘Hang Up and Listen’ helped with their other work (52:34) How Josh and Stefan’s relationship evolved as they worked together (57:33) Host: Joel Anderson Guests: Josh Levin and Stefan Fatsis Producer: Brian H. Waters Additional Production Support: Bobby Wagner Learn more about your ad choices. Visit podcastchoices.com/adchoices

Joining host Michael Azevedo on this episode is Josh Levin the writer and host of "Slow Burn: The Rise of Fox News", a 6-episode series that takes listeners back to a crucial inflection point in American history: the moment between 2000 and 2004 when Fox News first surged to power. When the Fox News Channel launched in 1996, critics called it disorganized, incompetent, and laughably inept. But it wouldn’t be a joke for long. During the 2000 election, Fox News would captivate the nation – and just maybe change the fate of American democracy. In the podcast series, which debuted in mid-September, Josh and his fellow producers talk to the hosts, reporters, and producers who built Fox News, many of whom have never spoken publicly. Josh Levine is the editorial director of the Slow Burn podcast. He was also the host of the Slow Burn seasons on David Duke and co-hosts the sports podcast Hang Up and Listen. He is the author of The Queen: The Forgotten Life Behind an American Myth . Making Media Now is sponsored by Filmmakers Collaborative, a non-profit organization dedicated to supporting media makers from across the creative spectrum. From providing fiscal sponsorship to presenting an array of informative and educational programs, Filmmakers Collaborative supports creatives at every step in their journey. About the host: www.writevoicecreative.com and https://www.linkedin.com/in/michael-azevedo/ Sound Engineer: A.J. Kierstead

In this podcast, Josh Levin, an American Ninja Warrior champion, discusses his experiences and mindset in overcoming obstacles and achieving success. He shares insights on giving back to the community, especially in areas like Puerto Rico. Levin's dedication to teaching and inspiring the next generation reflects his belief in showing that nothing is beyond reach and instilling the idea that individuals can achieve whatever they set their minds to. He explains the competitive and reality TV aspects of American Ninja Warrior, highlighting the focus on overcoming obstacles rather than just winning against others. Speaker Information Pavan Agarwal President and CEO of Sun West and Creator of Angel Ai Pavan Agarwal is the Chief Executive Officer of Sun West Mortgage Company, Inc., one of the largest independent, privately owned mortgage companies based in the U.S. Pavan is a major proponent of Fair Lending and using technology to create homeownership opportunities for underserved markets. He loves to bring innovation into the mortgage industry and seamlessly integrate business units, products, and disparate goals into a single architecture to achieve success. Pavan's exceptional achievements have garnered recognition from prestigious media outlets, including Fox News, Yahoo, and Bloomberg. He's also been nominated for a national philanthropy award for his work with The Autism Community in Action (TACA). Angelynne Elliot Managing Director of Organizational Development at Sun West As the Managing Director of Organizational Development at Sun West, Angelynne leads and supports the assessment of organizational needs as well as the creation, implementation, and evaluation of programs that assist the company's employees in their continuing career advancement. She also serves as a liaison and an advisor to the organization's leadership, facilitating initiatives across the board. Angelynne's foundational expertise is in Learning and Development, with demonstrated success in the financial services industry. She has a Master of Business Administration degree from the University of La Verne, California, and is a Certified Professional in Talent Development (CPTD), skilled in coaching, sales, communications, instructional design, team development, and project management. Josh Levin Professional Climber, American Ninja Warrior Athlete Hailing from Sunnyvale, California, Josh Levin is a prominent professional climber and American Ninja Warrior athlete. With a remarkable climbing career spanning nearly two decades, he has garnered numerous accolades, including 19 National Championship titles and 5 Continental Championships. Renowned for his prowess in speed, bouldering, and lead climbing competitions, he has solidified his status as one of the most versatile climbers in the sport. In addition to his climbing achievements, Josh made a significant impact on the American Ninja Warrior scene, earning the title of Rookie of the Year in Season 8 and making history as the first American rookie to clear Stage 3 in the USA vs. The World competition. Josh's commitment to the climbing community extends beyond competitions, as he actively engages in initiatives like trail cleanups, coaching, and youth development programs. American Ninja Warrior is a registered trademark of Tokyo Broadcasting System Television, Inc. American Ninja Warrior - a third party organization is not affiliated with Sun West Mortgage Company, Inc. The name of American Ninja Warrior is owned by American Ninja Warrior. Josh Levin's Intro Video Credit: https://www.instagram.com/gerald.lizardo_?igsh=a3J6MnVtZjRrbWdz Nothing Is Beyond Reachᵀᴹ 👉 AngelAi.com Advertisement. Sun West Mortgage Company, Inc. is acting as the Lender and offers financing to qualified borrowers. Sun West Mortgage Company, Inc is not affiliated with any third parties mentioned in the video. The names are owned by the respective third parties.

If you don't know him already, meet my new friend Josh Levin! He's the President of LympheDIVAS, a brand dedicated to helping us feel beautiful by offering stylish yet functional lymphedema garments. LympheDIVAS was created by Josh's late sister Rachel who ultimately lost her life to triple negative breast cancer. He continues to keep her incredible vision alive today. Tune in to learn about the "why" behind Josh's mission, how wearing a beautiful lymphedema garment can help you feel empowered, how to find the perfect lymphedema sleeve for you, the inspiration behind their unique, distinctive prints and so much more!

Gainsight is the platform everyone thinks of when they look at customer success tools. So when is team ready for Gainsight? What does it take to put it in place? What are its core advantages? When should CS teams consider Gainsight, and what use cases may require the addition of another tool in conjunction with Gainsight? We asked Josh Levin, Manager of CS at Honecomb.io to share his experience. Josh worked as a technical architect at Gainsight, and has also recently implemented the platform for his team at Honeycomb. Some of the lessons he's shared along the way include: - When CS teams should look at Gainsight as an option - What characteristics make Gainsight a poor fit for your organization - The pitfalls to avoid when starting an instance of Gainsight - Josh is also a brilliant mind and advocate for technical CS implementation. - He’s built custom data flows from product data, to Snowflake, and back to the GTM tech stack. He shared what he’s built, and why he believes technical skills in CS are a growing need.

In this episode Jason chats with journalist, podcaster, author and National Editor for Slate.com, Josh Levin. Find out more about Josh at josh-levin.com Podcasts https://slate.com/podcasts/one-year/s4/1942 https://slate.com/podcasts/slow-burn/s4/david-duke --- Support this podcast: https://podcasters.spotify.com/pod/show/voidedtransmissions/support

It’s September 27th. This day in 1986, NBA star Isaiah Thomas promoted “No Crime Day” in the city of Detroit. Jody, Niki, and Kellie are joined by Slate’s Josh Levin to talk about the effort, how it represented the approach to drugs and violence in the 1980s, and the legacy of Thomas’s initiative. Josh and his team have a full episode on No Crime Day in the latest season of Slate’s “One Year” podcast. Be sure to subscribe to Josh’s latest season of One Year wherever you get your podcasts! Sign up for our newsletter! Find out more at thisdaypod.com And don’t forget about Oprahdemics , hosted by Kellie, out now from Radiotopia. This Day In Esoteric Political History is a proud member of Radiotopia from PRX. Your support helps foster independent, artist-owned podcasts and award-winning stories. If you want to support the show directly, you can do so on our website: ThisDayPod.com Get in touch if you have any ideas for future topics, or just want to say hello. Our website is thisdaypod.com Follow us on social @thisdaypod Our team: Jacob Feldman, Researcher/Producer; Brittani Brown, Producer; Khawla Nakua, Transcripts; music by Teen Daze and Blue Dot Sessions; Audrey Mardavich is our Executive Producer at Radiotopia Learn about your ad choices: dovetail.prx.org/ad-choices

Welcome to Manufacturing Greatness with Trevor Blondeel, where we work with organizations to manufacture greatness by leveraging resources you already have to achieve greater retention, productivity, and profits. To learn more, visit www.manufacturinggreatness.com and click here to subscribe to Trevor's monthly newsletter. Now, let's jump in! In this episode, CEO Josh Levin joins the podcast to share how manufacturing and construction leaders can put culture first while still driving performance. We talk manufacturing leadership, accountability, trust building, and authentic leadership for Operations Managers, Production Managers, Manufacturing Managers, and Shift Supervisors. Josh breaks down how passion, clear expectations, and people-first leadership create stronger engagement and a workplace where teams actually want to show up. You will walk away with practical ideas to strengthen culture, improve communication skills, and build momentum through accountability on the shop floor. 0:37 – In some organizations, people are treated like batteries, which can be easily used and quickly replaced 2:04 – How can we shift our mindsets to focus on people over profit? 2:40 – If your team members don't feel valued, they aren't going to show up and do their best work 4:30 – Your employees, their needs, and their lives outside of work should matter to you as a leader 5:37 – Regular, thoughtful employee evaluations are a great way to show effort and retain employees 6:46 – Being the leader doesn't mean you have to be the voice or face of the entire organization 9:17 – Even if your business has a great brand, you can't thrive unless you have good culture 13:26 – Accountability and honest dialogue are an important part of building trust and relationships 14:45 – To improve, study the behavior of successful people—and pay attention to the behavior of non-successful people, too 20:18 – Remember that employees may have motives for showing up beyond simply loving your company, like needing to support their families 22:48 – As a leader, keep your "passion tank" filled 26:00 – Invest in your employees, especially those who are willing to put in the work 25:55 – "There's never a traffic jam on the extra mile." 28:10 – Someone's past doesn't have to dictate their future Connect with Josh Levin: To learn more about Empowered Electric, visit their website .

Send us Fan Mail This conversation is with Dr. Josh Levin, a family medicine physician who practices at the Aroga lifestyle medicine clinic in beautiful Victoria, BC. Dr. Levin has always been passionate about exercise and fitness - today he coaches and competes at a Master’s level in weightlifting and practices yoga. In his clinic he shares this passion with his patients, empowering them to make healthy lifestyle changes and helping them make informed choices about the risks and benefits of medical interventions. We cover: Weightlifting and what he loves about it The importance of consistency Thoughts on the phrase “exercise as medicine” Aerobic exercise vs resistance training How much exercise is optimal The optimal exercise intensity The effects of exercise vs medication on blood pressure How exercise helps control blood sugar The risks of sitting for long periods and what to do about it Benefits for depression How you don’t need to lose weight to benefit from exercise Prescribing exercise for healthcare professionals If you would like to reach out to Dr. Levin, you can contact him directly via email: josh@aroga.com Resources mentioned: Aroga Lifestyle Medicine Clinic website: https://www.aroga.com Br J Sports Med. 2019: How does exercise treatment compare with antihypertensive medications? Cochrane Review. 2021: The effect of walking on blood pressure control JAHA. 2013: Exercise training for blood pressure Diabetologia. 2017: Breaking sitting with light activities vs structured exercise Am J Clin. Nutr. 2006: The underappreciated role of muscle in health and disease Show sponsor: Warlockgolf.com use code PLANT15 at checkout for 15% off your order! Theme music by Tyler Gaudon and a special thank you to Wyatt Pavlik for the audio editing and processing Find me here, if you want to connect on Instagram: @plant_fueled That’s all for now! Be sure to subscribe and if you are enjoying the show, I would really appreciate it if you could leave a review! *Please appreciate that this information is not intended to be a substitute for professional medical advice, always seek the opinion of a physician or qualified healthcare provider* Audio editing and processing by Wyatt Pavlik Theme music by Ievgen Poltavskyi from Pixabay *Please appreciate that any information discussed is not intended to be a substitute for professional medical advice, always seek the opinion of a physician or qualified healthcare provider.*

Keith is joined by Josh Levin, National editor at Slate, host of the ‘ONE YEAR: 1977’ podcast, to discuss the story of Mary Shane, the first full-time female broadcaster for a Major League Baseball team, and Josh’s book ‘The Queen: The Forgotten Life Behind an American Myth’. Follow Keith on Twitter: @keithlaw Follow Josh on Twitter: @josh_levin Hosted on Acast. See acast.com/privacy for more information.

Bryan Curtis and David Shoemaker start by going through all their media notes about the Olympics (4:48). Then Slate's Josh Levin joins to talk about his new podcast, 'One Year,' (20:04) and Levin helps David guess this week's Strained-Pun Headline (45:10). Hosts: Bryan Curtis and David Shoemaker Guest: Josh Levin Production Assistant: Isaiah Blakely Hosts: Bryan Curtis and David Shoemaker Guest: Josh Levin Production Assistant: Isaiah Blakely Learn more about your ad choices. Visit podcastchoices.com/adchoices