Fujifilm Healthcare Europe received the European CE mark for its next-generation therapeutic linear array ultrasound endoscope, the EG-740UT, designed for complex diagnostic and therapeutic endoscopic ultrasound procedures.
The U.K. could be downgraded as a place to research and launch new medicines because of economic shocks and a looming rebate of 30% or more on sales of branded products, according to industry sources.
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D.
A new technique may allow reduction of intraocular pressure (IOP) associated with glaucoma without opening the anterior eye chamber, eliminating much of the risk associated with current glaucoma procedures. The cilio-scleral inter-position device (CID) facilitates outflow without creating an artificial egress using a thin one-piece implant.
The European Commission (EC) is proposing a novel cancer screening program that would improve cancer outcomes by fostering more frequent cancer screenings among European Union (EU) member nations. The primary focus is on screening for breast, cervical and colorectal cancers, but the plan carries a lofty target of providing screening services for 90% of those who qualify for screening.
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating cardiac arrhythmia. Results from the proof-of-concept-study were published in the Journal of Cardiovascular Electrophysiology.
EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market.