The EU Joint Scientific Consultation gives medical device developers a voluntary route to obtain targeted feedback on clinical evidence plans well before formal Joint Clinical Assessment and national reimbursement decisions. Manufacturers of select high-risk technologies can align their developme...

EU Joint Clinical Assessment is a distinct, harmonised process that operates separately from CE marking. It produces comparative clinical evidence on selected high-risk devices to support more consistent national reimbursement decisions across EU member states. Insights from the

LesionAttn Skin Cancer AI tackles a critical flaw in current skin cancer detection tools: models that unconsciously rely on background skin features differing between men and women, producing unequal accuracy across genders. By steering neural networks to focus on the actual lesion instead of the...

The CAPVAXIVE Pediatric Vaccine Approval expands options for children and adolescents aged 2 through 17 who have completed their primary pediatric pneumococcal series yet face elevated risk due to chronic conditions such as diabetes, heart disease, kidney disease, liver disease, or lung disease. ...

The USTR Germany Pharma Investigation has exposed how Germany’s pharmaceutical reimbursement policies force American patients to finance a disproportionately large share of worldwide drug research and development. By systematically suppressing prices below sustainable levels, these practices erod...

The Biotechnology Act Europe offers a once-in-a-generation chance to turn the continent’s world-class life sciences research into scalable commercial successes that remain in Europe rather than migrating elsewhere. By tackling regulatory fragmentation and sharpening investment signals, the legisl...