Scarlet
Scarlet is a European Notified Body specialised in software and AI medical devices, also an MHRA-approved body and FDA-recognised third-party reviewer.
Position in SVTR
Snapshot 2026-10-20- Startup SignalsTop 50%↓20
- Security & ComplianceTop 50%↓1
- Medtech Device#10of 39–
About
Scarlet is a European Notified Body specialised in software and AI medical devices, also an MHRA-approved body and FDA-recognised third-party reviewer. It runs a purpose-built certification pathway for SaMD/AIaMD makers, using its own platform to standardise submissions and automate completeness checks, serving medical AI companies such as Tandem Health, Skin Analytics and Lucida Medical.
Full tier & rationale — an SVTR Intelligence benefit
Capital graph
Founders / core team
Investors
Funding history
- 2026-10-13Series B$50M
Investors · Headline、Notion Capital、Atomico、Creandum、Kindred Ventures、Entrepreneur First
Comparable companies· by market
This company
BusinessLatest roundTotal raisedDate- Scarlet
Scarlet is a European Notified Body specialised in software and AI medical devices, also an MHRA-approved body and FDA-recognised third-party reviewer. It runs a purpose-built certification pathway for SaMD/AIaMD makers, using its own platform to standardise submissions and automate completeness checks, serving medical AI companies such as Tandem Health, Skin Analytics and Lucida Medical.
Series B · $75M · 2026-10
$75M
United States
BusinessLatest roundTotal raisedDate- Lumafield
Lumafield, founded in 2019 in Cambridge, Massachusetts, specializes in developing industrial X-ray CT scanners and software that help engineers view the interior of manufactured parts and products in 3D.
Series C · $75M · 2025-03
$75M - Nervonik
Nervonik, founded in 2020 in Los Angeles, California, USA, develops implantable peripheral nerve stimulation devices that deliver personalized chronic pain treatment through electrical signals and real-time sensing.
Series B · $53M · 2026-05
$53M - Proprio
Proprio, founded in 2016 and headquartered in Seattle, develops an AI-powered surgical platform. Its flagship product, Paradigm, has received FDA 510(k) clearance and is designed to improve surgical precision and efficiency.
Series B · $43M · 2023-08
$43M
China
BusinessLatest roundTotal raisedDate- BCI-Sonics
BCI-Sonics, founded in 2025 in Shanghai, China, develops a next-generation AI ultrasound brain-computer interface platform integrating AI algorithms, transcranial focused ultrasound (tFUS-LIFU), and multimodal neural decoding technologies, targeting deep, non-invasive, personalized BCIs for medical and neuroscience applications.
Series A · $42M · 2026-09
$42M - Kossel Medtech
Kossel Medtech is a Suzhou-based platform vascular-intervention device maker spanning peripheral intervention, coronary stents and balloons, cardiac electrophysiology and vascular access, neurovascular active devices, and core medical materials, plus OEM/CDMO manufacturing of implantable devices. Its products are registered in China, the US, the EU, Japan and South Korea, backed by nearly 100 device registrations and over 300 invention patents.
Series C · 2026-09
— - 磅策医疗
Pangce Medical (磅策医疗), founded in Shanghai, China in 2019, is a developer of medical surgical robots focused on core technologies including orthopedic and surgical robots and navigation positioning. The current funding round will be used for core technology iteration, new product pipeline R&D and clinical registration, commercialization channel expansion, and global market development.
Series B · $15M · 2026-04
$15M
Europe
BusinessLatest roundTotal raisedDate- Hilo
Hilo, founded in 2018 in Switzerland, develops wearable devices for continuous cuffless blood pressure monitoring, with models trained on optical signals and readings from over 120,000 users.
Series B · $61M · 2026-07
$61M - CMR Surgical
CMR Surgical, founded in 2014 in Cambridge, UK, sells robotic surgical systems to hospitals to assist surgeons in performing procedures for cancer and bowel disease treatment.
Undisclosed · $165M · 2023-09
$165M - Nami Surgical
Nami Surgical, founded in 2021 in Glasgow, Scotland, develops miniaturized ultrasonic medical devices for surgical applications, including high-performance compact ultrasonic scalpels designed to overcome limitations in robot-assisted surgery.
Undisclosed · $4M · 2024-05
$4M
Other / unspecified
BusinessLatest roundTotal raisedDate- UltraSight
UltraSight, founded in 2018 as a joint venture of the Weizmann Institute of Science and NYU Grossman School of Medicine (formerly OnSight Medical), builds Echosystem, an FDA 510(k)-cleared AI-guided cardiac ultrasound workflow platform that lets non-specialist clinicians perform diagnostic-quality bedside echocardiography under physician oversight. It is deployed across more than 10 U.S. commercial ICU sites.
Series B · $42M · 2026-09
$42M - TytoCare
Combines handheld medical devices with AI software to help doctors examine patients remotely
Undisclosed · 2026-07
— - Nuclivision
Nuclivision, founded in 2022 in Ghent, Belgium, develops AI software to enhance PET scan performance, enabling faster, lower-radiation imaging while maintaining diagnostic accuracy.
Undisclosed · $6M · 2025-04
$6M
Confirmed rounds only. Matched on subsector, sector, stage and funding scale — each verifiable on the company profiles.
Investors that may fit
Accel
21 Security & Compliance deals in the last 24 months · 12 at a nearby stage · 1 in Western Europe
Request intro →Ten Eleven Ventures
14 Security & Compliance deals in the last 24 months · 6 at a nearby stage · 2 in Western Europe
Request intro →Sequoia Capital
12 Security & Compliance deals in the last 24 months · 5 at a nearby stage · 1 in Western Europe
Request intro →Index Ventures
12 Security & Compliance deals in the last 24 months · 8 at a nearby stage · 1 in Western Europe
Request intro →General Catalyst
11 Security & Compliance deals in the last 24 months · 5 at a nearby stage · 2 in Western Europe
Request intro →Insight Partners
11 Security & Compliance deals in the last 24 months · 7 at a nearby stage · 2 in Western Europe
Request intro →Ranked by each firm’s deals in this sector over the last 24 months, weighted by nearby stage and shared geography. Indicative only — no rating judgment.