Tag: Weekly Brief

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Jan 19–26, 2026, #21)

A heavyweight week for the “reimbursement-first” era: chronic care platforms are hitting mega-round scale, NICE is formalizing the digital MSK pathway, and a French-made mitral valve just secured its ticket to the EU market.

People on the move

ONWARD Medical / Ali Kiboro
The Dutch-Swiss neurotech leader has appointed Ali Kiboro (ex-AliveDx, Quest Diagnostics) as CFO to steer the commercialization of its spinal cord stimulation systems.

BVI Medical / Jim Hollingshead
The former Insulet CEO takes the helm at the ophthalmology specialist as it deploys a $1B financing package to scale its global eye care portfolio.

mOm Incubators / Daniel Green
The portable neonatal tech startup named Daniel Green (ex-Caristo, Perspectum) as COO to lead the operational scale-up of its Dyson Award-winning incubators.

Money flows

Oviva
€200M ($217M), Series D, AI-enabled Chronic Care;
Led by Kinnevik (investing $100M) with participation from Planet First Partners and Norrsken VC. The funding scales its reimbursed digital programs for obesity, hypertension, and T2D across DACH and the UK.

Ananda Impact Ventures €73M, First Close, Health/Deeptech;
Backed by the EIF and NRW.BANK, this fifth Core Impact Fund targets later-seed and Series A healthtech startups across Europe.

Cancilico
€2.5M, Seed, AI Oncology; The Dresden-based spin-off is building automated hematology diagnostics (MyeloAID) to address the global shortage of pathologists.

On the press

  • HighLife SAS
    The Paris-based firm secured CE Mark for its Transcatheter Mitral Valve Replacement (TMVR) system, the first transfemoral, “one-size-fits-most” option for mitral regurgitation in Europe.
  • NICE Early Value Assessment (EVA)
    The UK body green-lit 8 digital technologies (including Hinge Health and Joint Academy) for NHS use in managing hip and knee osteoarthritis, provided they undergo 3 years of real-world evidence generation.
  • Abbott / TactiFlex Duo
    Won CE Mark for the world’s first dual-energy ablation catheter, allowing physicians to switch between pulsed field (PFA) and radiofrequency (RF) energy during a single AFib procedure.

One thing to remember

Evidence-backed, reimbursed digital care is moving from “pilot” to “platform.” The simultaneous arrival of a €200M round for payer-integrated care (Oviva) and NICE’s formal pathway for MSK apps signals that the “app” era is over, now it is the “clinical utility and evidence”.

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Europe MedTech & Digital Health Weekly Brief (Week of Jan 12–18, 2026, #20)

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

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Europe MedTech & Digital Health Weekly Brief (Week of Dec 6–12, 2025, #18)

Deal flow picked up: cardiology workflow hardware gets a seasoned chair, obesity tech hits a pivotal milestone, and Europe leans into AI—from a €10m cross-border programme to NICE nudging digital MSK tools forward.

People on the move

CathVision (Denmark): Eric Thepaut (ex-Boston Scientific EMEA) becomes independent chairman; company also ships ECGenius v3.5 to tighten EP lab workflows.

Money Flows

• New funds that will touch healthtech: University2Ventures (U2V) closes first tranche of a €60M fund for European university spin-outs; KBC launches a €100M Start it Fund for Belgian startups from idea to IPO.

• Xeltis (NL/CH): €40.3M equity + €9.7M debt (convertible loan + venture debt); to scale restorative cardiovascular implants and advance clinical programs.

• FICUS Health (DE): €3M Seed; AI documentation automation for rehabilitation clinics to cut admin time and integrate with German data standards.

• Punto Health (UK/ES): $2.7M Seed; building a speech-AI “OS for dementia care,” with pilots across NHS and Spanish centres.

• ONEHEALTH (NI/ROI): €10M cross-border programme backed by PEACEPLUS to support AI/digital health projects and SME pilots over four years.

On the press

• NICE moves digital MSK forward — Early Value Assessment for digital tools managing mild-to-moderate hip/knee osteoarthritis reached “Resolution,” with publication due Jan 22, 2026. Signal to SaMD teams: evidence + value proposition now.

• Nitinotes (IL/EU) hits pivotal first-patient milestone for EndoZip automated ESG; follows recent CE Mark enabling EU launch. Good read on automation entering bariatric endoscopy.

One thing to remember

The week says “AI with outcomes”: capital is flowing to workflow AI and documentation relief while public funding and NICE processes create room for evidence-led digital rollouts—set your 2026 plan to pair clinical claims with operational ROI and real-world pilots across EU/UK sites.

Categories
Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Sep 28–Oct 4, 2025, #8)

A brisk week: AI health coaching nets fresh capital, vet workflow AI gets a push, CE-marked remote monitoring scales, and Brussels opens the door for MDR/IVDR feedback.

People on the move

Dentsply Sirona: Aldo M. Denti appointed EVP & Chief Commercial Officer effective Oct 6 to align global business units with commercial execution. Mr. Denti brings extensive experience from J&J MedTech, especially DePuy (orthopaedics) and Acuvue (Vision Care).

Money flows

Simple Life (UK): €29.8M Series B, AI health coach; led by HartBeat Ventures. Plan: expand AI personalisation, gamification; claims strong revenue and active subs.

Lupa (UK): €17M Series A, AI-native operating system for veterinary clinics; launching a Veterinary AI Lab and scaling across Europe.

RDS (FR): €14M Series A to industrialise and expand MultiSense RDS, a CE-marked connected patch for continuous remote patient monitoring across Europe.

SeaBeLife (FR): €2M pre-Series A to advance dry AMD and severe acute hepatitis programs (biotech angle with medtech-adjacent implications for retina diagnostics ecosystems).

On the press

• European Commission launches a “Call for Evidence” on the future of MDR/IVDR (targeted revision to reduce burden, improve predictability, enable digitalisation). Deadline: Oct 6, 2025.
• HERA invites applications. Joint Industrial Cooperation Forum call is live; applications due by Oct 29, 2025 (17:00 CEST).
• Cardiology device rollout: Elixir Medical begins full European rollout of LithiX high-capacity IVL following CE mark; >400 patients treated across 16 countries.
• Swiss TAVI protection play advances in US. FDA clears pivotal trial for AorticLab’s FLOWer embolic protection system (already CE-marked in EU since 2024), signalling a scale-up trajectory for a Europe-born device.

One thing to remember

Regulation and reimbursement tailwinds matter: with Brussels actively revisiting MDR/IVDR and CE-marked RPM/IVL tools scaling across hospitals, founders who align early with compliance workflows and real clinical endpoints will move faster on procurement and pilots than those chasing generic “AI copilot” stories.