With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says that all COVID-19 enquiries are being prioritized ahead of its standard targets. It is offering an expedited advice service on coronavirus-related issues, meaning that companies wanting to make use of its other services may face some delays.
The agency says that exceptional use applications are now being processed to ensure a continued supply of non-CE marked...
The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.
MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
