In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more. Medtech Insight articles addressing topics discussed in this episode: • Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials https://medtech.pharmaintelligence.informa.com/MT123493/Breathing-Easy-ALung-CEO-Talks-Novel-Hemolung-Device-FDAs-Breakthrough-Pathway-Landmark-USUK-Clinical-Trials • US Breakthrough Devices Tracker https://medtech.pharmaintelligence.informa.com/datasets/us-breakthrough-devices

Pharma Intelligence Podcasts

Speaking Of Medtech, Ep. 2 – Breakthrough Medical Devices

Davinderpreet Mangat and Shardha Millington discuss the current and future role of long-acting agents in HIV treatment and PrEP. Topics covered include: HIV treatment – 4:30 HIV PrEP – 22:45 Supporting links: https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/hiv-pre-exposure-prophylaxis-hiv-prep/disease-analysis/article225313.ece https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/human-immunodeficiency-virus/disease-analysis/article225293.ece Other platforms: Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

HIV Treatment & PrEP – long acting agents

Scrip’s Five Must-Know Things – 18 October 2021 by Informa

Scrip’s Five Must-Know Things – 18 October 2021

In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.

Device Week, 13 October 2021 – Spotlight On The Latest Medtech-Industry News From The EU

In this month’s podcast, Medtech Insight's Reed Miller and Marion Webb provide a recap of our digital health coverage in August and September, including start-ups that grabbed new funding, news from AAOS 2021 and regulatory news. Medtech Insight articles addressing topics discussed in this episode: Akili Pays $37.5M To License Tali’s Tech For Early Childhood Attention Impairments https://medtech.pharmaintelligence.informa.com/MT144365/Akili-Pays-375M-To-License-Talis-Tech-For-Early-Childhood-Attention-Impairments Hagar Lands Funding To Develop Noninvasive Glucose Monitoring Watch https://medtech.pharmaintelligence.informa.com/MT144335/Hagar-Lands-Funding-To-Develop-Noninvasive-Glucose-Monitoring-Watch Flywheel.io Raises $22M And Buys Out Competition https://medtech.pharmaintelligence.informa.com/MT144463/Flywheelio-Raises-22M-And-Buys-Out-Competition Zoll Medical Signs Definite Agreement To Buy Itamar Medical For $538M https://medtech.pharmaintelligence.informa.com/MT144453/Zoll-Medical-Signs-Definite-Agreement-To-Buy-Itamar-Medical-For-$538M A Closer Look At Think Surgical’s Active Open Implant Orthopedic Robot and What’s Ahead https://medtech.pharmaintelligence.informa.com/MT144506/AAOS-2021-A-Closer-Look-At-Think-Surgicals-Active-OpenImplant-Orthopedic-Robot-And-Whats-Ahead Zimmer Biomet Canary Medical Win FDA De Novo For First Smart Knee Implant https://medtech.pharmaintelligence.informa.com/MT144400/Zimmer-Biomet-Canary-Medical-Win-FDA-De-Novo-For-First-Smart-Knee-Implant Exec Chat: AAOS 2021 Outgoing President Bosco Discusses Hot-Button-Issues – Inpatient-Only List, Pre-Authorization, New Tech https://medtech.pharmaintelligence.informa.com/MT144412/Exec-Chat-AAOS-2021-Outgoing-President-Bosco-Discusses-HotButton-Issues--InpatientOnly-List-PreAuthorization-New-Tech Market Intel: Robotic Surgery Holds Great Promise, But Is Not Quite There Yet https://medtech.pharmaintelligence.informa.com/MT144388/Market-Intel-Robotic-Surgery-Holds-Great-Promise-But-Is-Not-Quite-There-Yet New FDA Web Page Spotlights AI/ML Progress https://medtech.pharmaintelligence.informa.com/MT144493/New-FDA-Web-Page-Spotlights-AIML-Progress MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program https://medtech.pharmaintelligence.informa.com/MT144390/MDIC-Digital-Health-Initiative-Could-Be-Crucial-To-FDA-Pre-Cert-Program FDA Greenlights First-Of-Its-Kind Heart Software https://medtech.pharmaintelligence.informa.com/MT144454/FDA-Greenlights-First-Of-Its-Kind-Heart-Software Another Set Of Eyes: US FDA Authorizes AI Software To Spot Prostate Cancer https://medtech.pharmaintelligence.informa.com/MT144487/Another-Set-Of-Eyes-US-FDA-Authorizes-AI-Software-To-Spot-Prostate-Cancer Expert: AI/ML Pediatric Software Brings Hope – But Also Potential – To Magnifying Disparities https://medtech.pharmaintelligence.informa.com/MT144425/Expert-AIML-Pediatric-Software-Brings-Hope--But-Also-Potential--To-Magnifying-Disparities FDA Panel Meeting To Focus On AI/ML Device Labeling, Transparency https://medtech.pharmaintelligence.informa.com/MT144379/FDA-Panel-Meeting-To-Focus-On-AIML-Device-Labeling-Transparency Congress Marks First Telehealth Awareness Week https://medtech.pharmaintelligence.informa.com/MT144501/Congress-Marks-First-Telehealth-Awareness-Week For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Digital Health Roundup, 12 October 2021 – Record-Breaking Funding; FDA, AAOS 2021

Scrip’s Five Must-Know Things – 11 October 2021 by Informa

Scrip’s Five Must-Know Things – 11 October 2021

Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.

Pink Sheet Podcast: NIH Director Leaving, Federal COVID-19 Messaging Issues, FDA Assessment Costs

Device Week, Oct. 08, 2021 – Boston Scientific Acquisition, And Poor SPAC Float In this edition of Device Week, Medtech Insight’s Reed Miller discusses Boston Scientific’s acquisition of Baylis, and what it means for its heart business. UK-based reporter Barnaby Pickering looks into LumiraDX’s recent float on the stock market, and why it might have been so poorly received. Medtech Insight articles addressing topics discussed in this episode: - Boston Scientific Continues Acquisition Streak With $1.75Bn Deal For Baylis’ Cardiology Products - LumiraDX Goes Public In SPAC Merger

Device Week, Oct. 08, 2021 – Boston Scientific Acquisition, And Poor SPAC Float

Canadian biotech Providence Therapeutics CEO talks to Scrip on mRNA vaccines against COVID-19, cancer Shownotes – Providence Therapeutics CEO Brad Sorenson talks about his company’s plans for Phase II, III clinical trials for an mRNA vaccine as well as marketing and manufacturing partnerships with Biological E, Everest Medicines, Emergent Biosolutions and Northern RNA. He also discusses Providence’s m-RNA vaccines against cancer

Providence Therapeutic’s Sorenson on COVID-19 mRNA vaccine clinical trials, partnerships

In the inaugural episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt discuss remote facility inspections and question whether they’re the wave of the future. Medtech Insight articles addressing topics discussed in this episode: • Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections https://medtech.pharmaintelligence.informa.com/MT144289/Come-On-In-The-Waters-Fine-FDA-Should-Fully-Embrace-Remote-Inspections • Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels https://medtech.pharmaintelligence.informa.com/MT143997/Enforcement-Comeback-FDA-Predicts-1767-Increase-In-US-Inspections-In-FY-22-Matching-PrePandemic-Levels • To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments https://medtech.pharmaintelligence.informa.com/MT144053/To-RRA-Or-Not-To-RRA-BD-Talks-DecisionMaking-Around-FDA-Requests-For-Remote-Regulatory-Assessments • ‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise https://medtech.pharmaintelligence.informa.com/MT143998/We-Were-A-Victim-How-An-FDA-Remote-Regulatory-Assessment-Took-One-Device-Maker-By-Surprise

Speaking Of Medtech, Ep. 1 – Remote Inspections And Device Makers

Announcing The Inaugural Informa Pharma Intelligence Awards Japan 2022 by Informa

Announcing The Inaugural Informa Pharma Intelligence Awards Japan 2022

Scrip’s Five Must-Know Things – 4 October 2021 by Informa

Scrip’s Five Must-Know Things – 4 October 2021

In this week’s podcast, reporters discuss the high points of the recent AdvaMed MedTech Conference. Ferdous Al-Faruque goes in-depth on FDA comments about user fees, while Brian Bossetta discusses varying points of view on Medicare coverage of breakthrough devices – including the crucial role of real-world evidence.

Device Week, 1 October 2021 – MDUFA and MCIT In Spotlight At AdvaMed's MedTech Conference

Pink Sheet reporters and editors look at the search for COVID-19 vaccine correlates of protection, a potential effort to simplify the US FDA’s expedited approval pathways, and new guidance on the use of real-world evidence.

Pink Sheet Podcast: Vaccine Correlates, Simpler FDA Expedited Pathways, Real-World Evidence Guidance

Ex-Hilleman CEO talks to Scrip on COVID-19 vaccines and challenges as the disease becomes endemic

Challenges of COVID-19 vaccine heterologous boosting and endemic disease

Pharma Intelligence from Informa places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Informa is a leader in the field of healthcare industry information.

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Pharma Intelligence Podcasts

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