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In this month’s podcast, Medtech Insight's Reed Miller, Marion Webb, and Barnaby Pickering provide a recap of our digital health coverage from December and January, including Exec Chats with the CEOs of iRhythm and Cognetivity, discuss the potential of digital therapeutics for better health, including a company profile on Akili Interactive, and hig…
 
On this week’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering provide a recap of our J.P. Morgan Health Care conference coverage including Abbott, Dexcom, Zimmer Biomet and Nuvasive and spotlight Scottish company PneumoWave. Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in…
 
Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.…
 
In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.Medtech Insight article addre…
 
In this first edition of “Report Digest,” UK-based reporter Barnaby Pickering discusses the liquid biopsy for oncology market with analyst, Phil Greenfield. The two discuss the main market drivers, and exactly what experts think will occur in the sector in future years. For more information, take a look at Meddevicetracker’s report, here - https://…
 
On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices. Medtech Insight articles addressing topics discussed in this episode:• Right To Repair Proponents Gearing Up To Fight In State Legislatures A…
 
Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.Informa
 
In this episode, HBW Insight speaks to director general of the Association of the European Self-Care Industry (AESGP) and board member of the Global Self-Care Federation, Jurate Švarcaite. As a member of the GSCF board, Jurate has been involved in the creation of the association’s recently launched Charter for Environmentally Sustainable Self-Care,…
 
In the first Device Week podcast of 2022, Medtech Insight editor Marion Webb reviews the medtech highlights from CES, the world’s biggest technology convention. Listen to the podcast via the player below: The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on App…
 
Davinderpreet Mangat discusses the forecast for the RSV market.Supporting links:RSV forecasthttps://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/vaccines/respiratory-syncytial-virus-prevention/forecast/article133448.eceRSV disease analysis reporthttps://service.datamonitorhealthcare.com/hkc/disease/infectious-diseases/vaccines/…
 
Podcast descriptionDavinderpreet Mangat, Pamela Spicer, and Kevin Grogan discuss the skin disease landscape (atopic dermatitis and psoriasis).Topics covered include:• Atopic Dermatitis - 01:00• Psoriasis – 25:00Supporting links:• Datamonitor’s Atopic dermatitis disease analysis report - https://service.datamonitorhealthcare.com/hkc/disease/immunolo…
 
Ocugen’s founder and CEO Shankar Musunuri speaks to Scrip about his company’s mutation-agnostic gene therapy candidate OCU-400, a commercial agreement with CanSino Biologics and plans for a bridging study of partner Bharat Biotech’s COVID-19 vaccine Covaxin post a US FDA clinical hold.Informa
 
How can self-care companies operating in the UK avoid 'greenwashing' when making environmental claims for their OTC brands? In this episode, HBW Insight's David Ridley speaks to PHD Marketing managing director Jo Stephenson about the new UK Green Claims Code, and how OTC firms can navigate this new guidance on making claims for 'eco-friendly' produ…
 
Pink Sheet reporters and editors discuss US FDA commissioner nominee Robert Califf’s Senate confirmation hearing, new COVID-19 vaccine recommendations from the US CDC, and issues related to US approval of China-developed cancer drugs.Informa
 
On this week’s podcast: Robert Califf goes through his first round nomination hearing in the US Senate, Medtronic and BrainsGate hits their own snags, and the US FDA defines counterfeit products under its new authorities.Informa
 
In this special podcast, Medtech Insight commercial/R&D editor Reed Miller talks to In Vivo executive editor Ashley Yeo about the annual MTI 100 list and the major trends facing the top medtech companies entering the third year of the pandemic.Related articles: https://medtech.pharmaintelligence.informa.com/datasets/company-rankings-2022https://med…
 
In this edition of Device Week, Medtech Insight’s Marion Webb talks to UK-based reporter Barnaby Pickering about Cognetivity’s FDA approved diagnostic tool for Alzheimer’s. The company hopes that by providing earlier diagnosis, cost savings in the trillions of dollars can be made. Reed Miller also discusses Boston Scientific’s new “Modular” cardiac…
 
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’…
 
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