Citeline Podcasts

On this week's Medtech Insight podcast: FDARA user-fee bills progress in the US Congress; a deep-dive look into the US Open Payments database yields interesting news and trends; in an unusual step, US FDA publicly releases an inspection observation form after auditing Magellan Diagnostics; standards organization GS1 and the Healthcare Industry Distributors Association try to solve billing headaches; top management is shaken up at Zimmer Biomet.

On this week's Medtech Insight podcast: supply-chain oversight program MedAccred makes a splash in industry; first diagnostic to use flow cytometry to detect rare blood cancers wins US FDA clearance; Ethicon sues Intuitive over surgical tool patents; Konica Minolta snaps up Ambry Genetics for $1bn; “Petya” and “Wannacry” ransomware attacks concern industry; a Thermo Fisher leader talks with Medtech Insight about the regulatory experience surrounding its Oncomine Dx Target Test.

US FDA recently approved the first multi-drug next generation sequencing test made by Thermo Fisher Scientific called Oncomine Dx Target Test. The test is a companion diagnostic for lung cancer drugs made by Novartis, Pfizer and AstraZeneca, and the diagnostic company is looking to expand their partnership to other pharma companies. Medtech Insight chatted with Joydeep Goswami, president of Thermo Fisher’s Clinical Sequencing Division for this podcast.

On this week's 100th Medtech Insight podcast: a new value-based reimbursement scheme emerges between Medtronic and Aetna; a major escalation in cybersecurity threats to medical devices concerns industry; the US Senate plans to keep the device tax repeal in its reworked health-care bill; a look at US FDA funding; two innovative device companies are spotlighted; medtech legal advocates want to bring FDA’s 510(k) process before the Supreme Court; virtual reality therapy gains traction.

We talked to Center for Drug Evaluation & Research Office of Medical Policy Director Jacqueline Corrigan-Curay at BIO about FDA’s current work on real world evidence. Corrigan-Curay explained how FDA doesn’t see a contradiction between randomization and RWE and ways to gradually start incorporating real world data in the drug development.

All businesses that scale up have to tackle funding, location and people to speed the way to international markets. In this podcast, Informa’s Global Content Editor Mike Ward discusses growing a biotech business at this year’s BIO International Convention with Gil Van Bokkelen, chief executive of Athersys Inc; Chris Doherty, managing director of Alderley Park, the UK’s largest single site bio campus; and Steve Bates, chief executive of the UK’s BioIndustry Association.

Link: https://mspl.co.uk/

On this week's Medtech Insight podcast: US congressional hearing highlights India’s efforts to place price caps on foreign-made devices; Senate health-care bill nixes device tax; Costa Rican quality control experts lean on each other for industry education; US FDA issues a draft guidance on electronic records and signatures.

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

UK medtech industry’s plans to encourage more international business for home-grown companies.

On this week's Medtech Insight podcast: amendments targeting device accessories, medical imaging and post-market surveillance tacked onto FDA Reauthorization Act; a project funded by the US Department of Homeland Security aims to improve device cybersecurity; FDA moves to implement more 21st Century Cures legislation; the Sentinel Cerebral Protection System gains de novo clearance; a report from the MiXii Biomed Life Sciences and Technology Conference in Tel-Aviv.