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In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, Ferdous (Danny) Al-Faruque and Barnaby Pickering provide a recap of our digital health coverage in November including interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements.Medtech Insight articles addressing topics discu…
 
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break…
 
Nearly three quarters of the UK adults suffer from sleep problems, yet the majority of them do not seek help. In this episode, HBW Insight's Senio Editor, Europe, David Ridley, speaks to Perrigo VP and PAGB president Neil Lister about what consumer healthcare companies can do to help sleep-deprived British consumers. We talk about UK sleep brand Ny…
 
Pink Sheet reporters and editor review Acting Commissioner Janet Woodcock’s long career at the US FDA and update Robert Califf’s confirmation process, consider the advisory committee decision on Merck’s oral COVID-19 treatment, and discuss an under-the-radar case on 340B policy at the US Supreme Court.…
 
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.Informa
 
In this episode, HBW Insight’s US and EU Managing Editors Malcolm Spicer and Tom Gallen analyse Q3 OTC business trends, including why the biggest pharmaceutical companies in the world are spinning out their consumer health businesses to create new, publicly listed standalone firms and what's causing the supply chain troubles that are driving up OTC…
 
Pink Sheet reporters and editors discuss the authorization of COVID-19 vaccine booster shots for all adults, Aduhelm’s impact on Medicare Part B and rejection by EMA, and the nomination of ex-FDA commissioner Robert Califf for another term.Informa
 
In this edition of Device Week, Medtech Insight’s Reed Miller chats to Marion Webb about the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Reed and Barnaby also discuss recent results from the UK’s 100,000 Genome project, and how its analysi…
 
In this episode of Speaking Of Medtech we discuss the regulatory side of digital health – that is, the US FDA side of digital – and some of the more important related policies and activities that are going on at the agency right now.Medtech Insight articles addressing topics discussed in this episode:• What Does ‘Digital’ Mean For FDA’s Device Cent…
 
On this week’s podcast: The US FDA finally issued a draft guidance for medical software in the premarket space, while an agency panel meeting focused on the safety of graft stents.Medtech Insight articles addressing topics discussed in this episode:• FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says…
 
In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb and Ferdous (Danny) Al-Faruque provide a recap of our digital health coverage in October including updates on the digital therapeutics sector and FDA guidance documents.Medtech Insight articles addressing topics discussed in this episode:https://medtech.pharmaintelligence.informa.c…
 
In this episode, HBW Insight Senior Editor David Ridley chats with Bayer’s Daniella Foster about the emerging self-care movement. Daniella is global vice president and Head of Public Affairs, Science & Sustainability for Bayer Consumer Health. We dive deep into what is driving the self-care movement and some of the challenges industry faces in buil…
 
Pink Sheet reporters and editors discuss the congressional agreement to allow Medicare drug pricing negotiations, the authorization of the Pfizer/BioNTech vaccine for children age 5 to 11, and the departure of the US FDA’s Chief Scientist.Informa
 
In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Medtronic’s “refreshed brand” on environmental, social and governance targets. Managing editor Marion Webb highlights her deep-dive pieces on CEO post-pandemic perspectives while UK-based reporter Barnaby Pickering provides an analyst perspective on …
 
In this episode of Speaking Of Medtech we talk about arguably one of the biggest regulatory changes to come down the pike in decades: the ongoing harmonization of the US FDA’s QSR, which is going to broadly change the way the agency handles medical device quality oversight.Medtech Insight articles addressing topics discussed in this episode:• QSR A…
 
On this week’s podcast: The US FDA put some teeth to its regulation of the implants by issuing several new mandates, including a requirement that surgeons warn patients about the risks of the devices prior to surgery. Also this week the agency released its annual list of priority guidance documents.Medtech Insight articles addressing topics discuss…
 
Pink Sheet reporters and editors discuss the issues that could arise when the COVID-19 vaccines are given to children age 5 to 11, Merck’s agreement to share the license for its proposed oral COVID-19 treatment, and problems for a sponsor blocked by an accelerated approval conversion to full approval.…
 
Following the publication of its Self-Care Readiness Index, HBW Insight's David Ridley speaks to Global Self-Care Federation chair Heiko Schipper about what it takes to build a worldwide movement for self-care. We also discuss how industry players like Bayer Consumer Health - which Schipper heads up as division president - can contribute, for examp…
 
In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.Listen to the podcast via the player below:The archive of Device Week and the rest of Informa Pharma Intelligence’…
 
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 ar…
 
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 – 4:30HIV PrEP – 22:45 Supporting links:https://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/viral-infections/hiv-pre-exposure-prophylaxis-hiv-prep/disease-analysis…
 
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.Informa
 
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 C…
 
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.Informa
 
Device Week, Oct. 08, 2021 – Boston Scientific Acquisition, And Poor SPAC FloatIn 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 …
 
Canadian biotech Providence Therapeutics CEO talks to Scrip on mRNA vaccines against COVID-19, cancerShownotes – 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 Biosolutio…
 
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:• C…
 
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.…
 
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.Informa
 
On this week’s podcast: One of the more interesting and important trends in medtech in recent years is the emergence of robotic assisted surgery. But as RAS procedures increase, so do the chances of something going wrong. And when it does, who’s to blame? The robot or the surgeon?Medtech Insight articles addressing topics discussed in this episode:…
 
HBW Insight's David Ridley speaks to regulatory expert and TheScienceGrad founder Natash Barrow about trust in self-care, and how consumer healthcare companies can become a 'source of truth' in a confusing and misleading world.Informa
 
In this edition of Device Week, Medtech Insight’s Marion Webb gives a summary of this year’s American Academy Of Orthopedics annual meeting, where she discusses new products from a range of companies, and interesting meetings with executives. UK-based reporter Barnaby Pickering sheds light on Owlstone Medical’s new diagnostic method, and Editor Ree…
 
Pink Sheet reporters and editors discuss new developments in US drug pricing reform, FDA considering mandatory opioid prescriber education again, and including China in the agency’s international parallel review initiative, Project Orbis.Informa
 
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