Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

A recent pilot program from public-private partnership MDIC attempted to apply the FDA’s established Voluntary Improvement Program framework to manufacturers with known compliance issues. Participants found an improved mindset, a better relationship with the FDA, and conclusions to ongoing enforcement actions.

A new FDA guidance addresses concerns about device shortages due to ethylene oxide (EtO) restrictions by allowing manufacturers of class III devices to switch sterilization sites before filing a PMA or HDE, helping to prevent supply chain disruptions and ensuring timely device sterilization.

Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.

How a medical doctor with software development interests who is pursuing a career in medtech consultancy claims to have exposed a huge overspend on the EU’s medical device database. But is he comparing like for like?

Illumina's successful appeal to the European Court of Justice could transform life science transactions. However, the ruling has notable limitations and further jurisdictional stretch from the European Commission is expected, said Latham and Watkins lawyers at the Jefferies London Healthcare Conference.

Germany’s governing coalition may have folded, but embattled health minister Lauterbach has championed his hospital reform bill to the last. Now voted through in the upper house of parliament, the bill to reform diagnosis related groups and hospital care delivery will come into force on 1 January.

Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.

Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

Guardant Health expects to breakeven by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.

Illumina's successful appeal to the European Court of Justice could transform life science transactions. However, the ruling has notable limitations and further jurisdictional stretch from the European Commission is expected, said Latham and Watkins lawyers at the Jefferies London Healthcare Conference.

Germany’s governing coalition may have folded, but embattled health minister Lauterbach has championed his hospital reform bill to the last. Now voted through in the upper house of parliament, the bill to reform diagnosis related groups and hospital care delivery will come into force on 1 January.