The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld.

The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.

The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.

News comes from the U.K. Intellectual Property Office at the beginning of May 2024, where Ethicon, a Johnson & Johnson MedTech company, applied for five additional years patent protection for its Ethizia hemostatic sealing patch, whose embedded Pox polymer system dehydrates blood and accelerates the coagulation cascade to in occur in seconds, forming a tight yet flexible seal that maintains a barrier to bleeding.

Two companies – Head Diagnostics Ltd. and Octave Bioscience Inc. – identified biomarkers that could provide objective assessments of disease progression and response to treatment for patients with multiple sclerosis.

Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.

Urteste S.A. has developed a urine-based diagnostic test for the early detection of brain tumors. The prototype, which can detect the activity of brain-specific enzymes in urine, is a breakthrough test and the first solution of this type in the world, Grzegorz Stefański, CEO and co-founder of Urteste S.A., told BioWorld.

The European Council formally approved another delay for the In Vitro Diagnostic Regulation implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.

The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.

Vyaire Medical Inc., of Mettawa, Ill., reported a class I recall of its Twin Tubes devices, which are used in the collection of air samples during cardiopulmonary exercise testing. The recall was prompted by the risk that the device nozzle will separate during patient use and potentially result in choking, although the FDA said there have been no reports of adverse events in connection with the problem.