Incepto SAS, reported it has closed $26 million in series B capital to support European expansion of its AI medical imaging platform. 

The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market.

In a development that is a potential boon for wearables and other sectors of the digital health industry, the U.K.’s NICE has petitioned the National Health Service (NHS) to expand its coverage of devices that monitor patients with Parkinson’s disease. That data would be used by NICE to inform a health technology assessment that might ultimately boost sales of these devices if the data suggest a strong benefit to patients and to the U.K. health care budget.

Precisis GmbH is ready for market rollout after securing CE marking for its minimally invasive brain pacemaker for treating drug refractory epilepsy.

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.

Siview SAS chose the European Society of Cataract and Refractive Surgeons annual congress to announce its latest capital increase. 

Ecential Robotics SAS reported U.S. FDA 510(k) clearance for its 3D imaging, navigation and robotics guidance system.