Regulation
The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.
Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.
European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
When former FDAer Steve Silverman last wrote for us, there was no formal successor to Jeff Shuren as director of CDRH. With the elevation of acting director Michelle Tarver, the future is becoming more clear.
House Republicans say the FDA has not done enough to support its laboratory safety office, despite past recommendations.
An agreement between the EU and Switzerland potentially opening the way for renewal of the MRA – enabling barrier-free cross-border medtech trade – could be concluded as early as December. More good news for Switzerland, relating to the acceptance of FDA-approved products into the country, could follow in Q1 2025.
The European Parliament wants the European Commission to revise the Medical Device Regulation within 100 days. But EU member state authorities warn of the consequences of rushing matters.
The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for postmarket studies.
As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.
A new UK medtech survey sets out industry’s market access and regulatory concerns and makes clear where system users see the need for improvement. There are some grounds for optimism, but the MHRA’s planned rise in regulatory fees could undo some of the good work.
Achieving a balance between regulatory controls and promoting innovation is proving one of the biggest challenges that the EU is facing since the implementation of the MDR and IVDR. But there are ways through.
This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.
The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.
The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.
Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.
The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.
Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.
Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, highlights the crucial unmet need for needle-free devices to treat type 1 allergic reactions, given challenges associated with current epinephrine injectors. Hear what’s next for the Neffy intranasal spray and ARS Pharmaceuticals.
The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.
The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.