Quiet but productive: seed checks for prevention and preclinical tools, one neat CE mark, and a fresh EU call.
People on the move
Qureight / Rebecca Simmons
Ex-Riverlane operator becomes COO to scale the Cambridge clinical-trial imaging platform. [Source]
NanoSyrinx / Thomas Farrell
The UK-based intracellular drug delivery innovator appointed Thomas Farrell as CEO to steer its nanosyringe platform from concept to clinic; founder Joe Healey transitions to CSO. [Source]
BICO / Ewa Linsäter
The Swedish bio-convergence giant (formerly Cellink) tapped Ewa Linsäter as its new CFO to stabilize financial strategy following a period of aggressive M&A. [Source]
Money flows
ShanX Medtech
€24M package (equity, Innovatiekrediet, and €8.85M EC contract by DG HERA and HaDEA) to accelerate validation and EU launch of ultra-rapid infection diagnostics.
Ahead Health
$6M Seed, preventive “AI-native” health system; funds expansion across Europe and product development.
FluoSphera
€1.23M Seed. Geneva startup scaling an animal-free multi-tissue preclinical platform to speed drug discovery; backing from Soulmates Ventures and others.
On the press
FDA & EMA issue joint AI guidance
Regulators on both sides of the Atlantic published a “10 Principles” document for AI in medicine, creating a rare unified framework for lifecycle management and GxP compliance, a massive win for startups tired of dual documentation.
Boston Scientific scores CE Mark for Embold
The medtech giant received European certification for its Embold detachable coil system, expanding its neurovascular portfolio for treating stroke and aneurysms in EU centers.
Innovative Health Initiative (IHI) Call 12
The EU’s IHI partnership launched its single-stage Call 12, offering applicant-driven funding (50% public match) for consortia tackling unmet clinical needs—a prime target for startups seeking non-dilutive runway.
ACCESS-AD consortium
Amsterdam- and London-led public-private effort kicks off to accelerate Alzheimer’s diagnosis and treatment pathways in European health systems.
One thing to remember
With the new FDA-EMA joint AI guidance, “regulatory harmonization” is finally more than just a buzzword. Smart founders will use these 10 principles to build a single validation dataset that satisfies both watchdogs simultaneously, potentially shaving 12–18 months off their global commercial roadmap
