MedTech MasterClass — Understand, Decide, Act, organised by Humanae Partner, is taking place on 15 September 2026 at Impact Hub Lausanne.

This half-day face-to-face session for managers and executives wishing to understand, assess and make decisions regarding a proposed entry into the MedTech sector. The GoNoGo method, regulatory compliance, go-to-market strategy.
You will gain a better understanding of the following topics:
• Assessing whether your MedTech project is viable before committing significant resources
• Understanding the regulatory framework for medical devices [MDR (EU) 2017/745]
• Using the GoNoGo method to objectively assess your decision to launch or maintain a product on the market
• Identifying hidden costs, organisational risks and strategic levers
• Mitigating the risks of your market entry strategy

15 September 2026 | Impact Hub, Lausanne | Register (Fee from 185 CHF)

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The Vaud-based AI-native healthcare technology company announced a new global collaboration to develop, validate, and deploy two companion diagnostics (CDx) supporting precision oncology therapies with AstraZeneca .

This multi-year collaboration agreement will advance the development and commercialisation of two companion diagnostic programmes, bringing SOPHiA GENETICS’s decentralized clinical trial assays and companion diagnostic capabilities to AstraZeneca therapies.

As part of the collaboration, SOPHiA GENETICS will develop its Solid Tumor application into a decentralized companion diagnostic. In addition, the company will develop and validate its Hematological Oncology application to support a companion diagnostic program for patients with blood cancer.

“A breakthrough therapy only matters to the patients we can find in time to treat. We are moving towards a future that no longer depends on geography, where any laboratory can run the same test to the same high standard on day one of a launch. We believe these programmes are what that future looks like in practice. Bringing the right therapy to the right patient, in any country and any laboratory, is the work that will define the next generation of precision medicine,” said Ross Muken, CEO, SOPHiA GENETICS.

By combining accurate biomarker detection with rapid deployment, SOPHiA GENETICS aims to shorten the distance between a new therapy and the patients who need it. Through its global data-driven platform, insights generated from patient populations can help advance informed clinical decision-making across healthcare systems. This vision of connected, data-driven medicine underpins these programmes, with the goal of expanding access to innovative treatments and improving outcomes for patients worldwide.

About SOPHiA GENETICS Companion Diagnostics

SOPHiA GENETICS end-to-end diagnostic capabilities span the drug development and launch continuum:

Clinical Trial Assay (CTA) development, to identify, screen, and enroll the right patients quickly and accurately during a trial.
Companion Diagnostic (CDx) development, validation, and regulatory submission, taking an assay from research use through analytical and clinical validation to approval in the US, EU, Japan, and beyond.
Deployment through the SOPHiA DDM Platform and the SOPHiA DDMTM MaxCare Programme, enabling laboratories to bring testing in-house and adopt new genomic applications with confidence, reaching larger populations around the globe.
SOPHiA GENETICS’s technology-agnostic, cloud-based platform lets healthcare institutions run the same validated, AI-powered analysis locally, while sharing and benefiting from the collective intelligence of a global network of more than 1,000 connected institutions across over 75 countries. For a pharmaceutical partner preparing a global launch, that means a companion diagnostic that can be available in the local lab on day one of drug approval.

Source: Press Release | ©SOPHiA GENETICS

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The 25th European Conference on Computational Biology (ECCB) is taking place in Geneva from 31 August until 4 September 2026, under the theme “Biodiversity, AI & Health: computational biology to address the challenges of our time”.

The conference will explore how computational biology and bioinformatics contribute to understanding biological diversity, advancing health research, and addressing global societal challenges through data-driven approaches.
Organized by the SIB Swiss Institute of Bioinformatics, ECCB 2026 will bring together 1,000–1,200 experts from around the world, including bioinformaticians, computational biologists, developers, biocurators, and clinicians from academia, industry, and public healthcare.

ECCB 2026 will feature an outstanding line-up of keynote speakers, including Guy Parmelin (President of the Swiss Confederation), Jeremy Farrar (World Health Organization), Stephen Quake (Chan Zuckerberg Initiative), and Aleksandra Walczak (École Normale Supérieure).

31 August – 4 September | CICG – Geneva | Information and Registration

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NewBiologix S.A., a Swiss Health Valley biotechnology company advancing recombinant adeno-associated virus (rAAV) production through next-generation clonal HEK293 cell line technology, announced publication of peer-reviewed data in Biotechnology Reports (Vol. 49, March 2026).

The paper (1), authored by NewBiologix, covers the generation and characterization of NBX1P01, the company’s proprietary clonal HEK293 cell line optimized for rAAV production. Derived from more than 2,000 single-cell clones, NBX1P01 was selected for enhanced production performance and validated through extensive genomic sequencing to confirm clonality and stability. This clonal cell line underpins rapid, effective, and scalable production of viral vectors central to gene therapy manufacturing.

After comprehensive evaluation, the publication reports the following key findings:

● Full-to-empty capsid ratio: In head-to-head studies using identical protocols, NBX1P01 demonstrated a two-fold higher full-to-empty rAAV capsid ratio compared to a leading commercial HEK293 cell line. Full capsid content is a critical product quality attribute in rAAV manufacturing.
● Genomic stability: The clone remained genomically stable over 55 population doubling levels and exhibited lower genetic heterogeneity than the parental HEK293 population.
● Genome integrity: Long-read sequencing confirmed more than 70% intact rAAV genomes with minimal encapsidated contaminating DNA.
● Scalability and versatility: NBX1P01 demonstrated consistent performance across production volumes ranging from 10 mL to 1.5 L and supported multiple rAAV serotypes and clinically relevant transgene sizes.

Igor Fisch, CEO and Co-founder of NewBiologix, said, “As the gene therapy landscape evolves, manufacturing platforms must radically improve in performance. Our goal is to help revolutionize gene therapy by ushering in a more reliable and consistent industrial scale manufacturing foundation. This peer-reviewed publication validates our precision-built, high performance, stable HEK293 platform and showcases its reliability and consistency for quality rAAV production.”

Efrain Guzman, VP, Innovation & Business Development at NewBiologix, said, “We’re determined to make gene therapies more accessible and provide safe and effective therapies to patients. In viral vector manufacturing, quality is essential to assure the product’s integrity from day one. Choosing a reliable, stable and adaptable cell line that demonstrates consistent performance is foundational to achieving that goal.”

Manufacturing scalability and product quality remain central challenges in rAAV-based gene therapy development, particularly as programs expand beyond rare diseases into broader patient populations. Improvements in cell line stability impact product quality and dramatically reduce variability, thereby increasing manufacturing efficiency and enhancing overall product consistency.

For additional technical information, see the company’s latest Scientific White Paper (2).

References

(1) Generation and characterization of a HEK293 cell line optimized for recombinant adeno-associated virus production: https://doi.org/10.1016/j.btre.2026.e00948

(2) Unlocking Scalable, High-Quality rAAV Production with Xcell Eng-HEK293: https://145175225.hs-sites-eu1.com/white-paper-hek293

Source: Press Release | Igor Fish, CEO and Co-founder of NewBiologix. ©NewBiologix

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Healthcare Konnect (HCK), a Geneva-based startup, and Binarios by T2S Group, a Moroccan company, announce a strategic partnership aimed at expanding access to medical AI solutions in key regions in North and West Africa.

Today’s medical institutions and clinicians constantly need pertinent, quantitative and qualitative indicators to support decision-making and reporting, all the while maintaining efficiency in routine care. Healthcare professionals urgently require modern, effective solutions to manage data from multiple sources to improve quality of care, optimize their workflow and achieve significant cost savings. This partnership is a step forward in the road of making cutting-edge technologies accessible and seamlessly integrated in healthcare institutions.

Binarios is a subsidiary of the company T2S Group, a leading actor in medical IT that continuously develops solutions to meet the needs of doctors with the most advanced medical hardware and software. Binarios offers a comprehensive suite of solutions, including VisionPACS®, VisionRIS® and VisionLIS®, which have already become the benchmark in multiple regions of the world, especially in Africa. This collaboration perfectly aligns with HCK’s focus on North/West African countries to further support the widespread use of AI in healthcare. Through this partnership, HCK’s platform of innovative AI medical solutions will be available in Binarios’ network counting more than 500 centers.

Source: Press Release | Healthcare Konnect (HCK)

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The Vaud-based startup introduces an AI‑supported, human‑centered platform that turns regulatory knowledge into actionable go-to-market strategy, already serving EU and US markets, covering MDR, IVDR, FDA and emerging AI regulations.

QARAlink, a Swiss startup building an AI-supported regulatory intelligence platform for MedTech and HealthTech companies, has raised USD 936,000 in pre-seed funding at an approx. USD 5.6 million valuation. Backed by business angels, venture capital, partners and government grants, the round will accelerate QARAlink’s mission to shorten time-to-market by replacing scattered, complex, manual compliance work with a structured, collaborative system that keeps pace with changing global regulations.

Founded in 2024, QARAlink combines regulatory expertise with cutting‑edge AI to capture, structure and operationalize regulatory knowledge. Teams can plan proactively, automate routine checks, and maintain audit-ready evidence, helping them anticipate changes, reduce rework, and move products through MDR/IVDR and FDA pathways with greater efficiency and predictability.

“We’re building QARAlink because regulatory intelligence should be accessible, collaborative and actionable,” said Tom Petty, Co‑founder and CEO of QARAlink. “This round is a vote of confidence in the urgency of the problem and our approach, making compliance not just easier, but smarter and faster, so MedTech innovators can reduce risk, save money, and stay focused on their life-changing products.”

The round combines cash with a portion of in‑kind services from trusted technology partners, aligning resources with QARAlink’s roadmap and early customer traction. Funds will be used to accelerate market entry, boost state-of-the-art AI capabilities, and expand the company’s cross‑functional team across regulatory affairs, data management, and product research and development.

“I invested in QARAlink because they’re not just adding AI, they’re reimagining how humans interact with it. Their platform relieves the burden of navigating complex knowledge, keeping people at the heart of decisions. That’s the kind of future I believe in.” – Anonymous business angel, Switzerland.

“Regulatory work too often lives in scattered documents and tacit know‑how. QARAlink’s structured, AI‑supported approach brings order and speed to a mission‑critical function. The team’s regulatory depth and product discipline convinced me they can execute.” – the kind of future I believe in.” – Anonymous business angel, Canada.

QARAlink will launch the first version of its platform later this year, offering early adopters an AI‑supported, compliance‑ready knowledge system designed to seamlessly integrate, support and empower Regulatory Affairs, Quality Assurance and Compliance teams, reduce friction and make regulatory readiness a strategic advantage.

Source: Press Release | ©QARAlink

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SOPHiA GENETICS launched a new podcast series titled Decoded, hosted by CEO Dr. Jurgi Camblong. The series aims to make complex medical technologies — from AI-powered diagnostics to liquid biopsy — accessible and understandable to healthcare professionals and the wider public.

The opening episode, Liquid Biopsy Decoded, features Prof. Umberto Malapelle, Chair of the Predictive Molecular Pathology Laboratory at the University of Naples Federico II and President of the International Society of Liquid Biopsy. The discussion explores how liquid biopsies and clinical AI are transforming cancer diagnosis and why the public conversation on AI must go beyond generative models.

Available now on Spotify and Apple Podcasts, the podcast offers short, expert-led episodes designed to inform, clarify, and connect innovation with real-world patient impact.

Podcast

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SOPHiA GENETICS, a Swiss cloud-native healthcare technology company and global leader in data-driven medicine, announced the expansion of its ongoing collaboration with AstraZeneca to accelerate the deployment of MSK-ACCESS® powered with SOPHiA DDM globally. Building on the initial collaboration announced in October 2024, this new phase will extend the test’s reach to a total of 30 clinical institutions worldwide in 2025.

Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS® powered with SOPHiA DDM is an innovative liquid biopsy testing application designed to detect actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyse circulating tumour DNA (ctDNA). The application supports real-time cancer monitoring and treatment selection when traditional tissue biopsies are not feasible due to cost, turnaround time, insufficient tissue, or the invasiveness of the procedure.

The expanded rollout will continue to contribute to AstraZeneca’s global real-world evidence initiatives and help further validate the clinical impact of decentralized liquid biopsy testing across diverse healthcare systems. By increasing the availability of MSK-ACCESS® powered with SOPHiA DDM, SOPHiA GENETICS and AstraZeneca aim to understand further how liquid biopsy testing can complement solid tissue testing and, in some cases, provide greater benefit for labs and patients.

The announcement coincides with SOPHiA GENETICS’s presentation at AACR (American Association for Cancer Research’s Annual Meeting in Chicago) on 30 April 2025, in which the company presented data demonstrating the robust transferability of the decentralized MSK-ACCESS® powered with SOPHiA DDMTM solution. Historically, site-to-site discordance has been a major barrier to the widespread adoption of liquid biopsy testing. SOPHiA GENETICS presented real-world data highlighting the consistent accuracy and precision of MSK-ACCESS® powered with SOPHiA DDMTM across various laboratory settings. Interim results from the multicentre study demonstrated the high analytical performance of the decentralized test in line with the original single-site test at Memorial Sloan Kettering Cancer Centre in New York.

“Our collaboration with AstraZeneca represents a significant step toward scaling next-generation oncology diagnostics globally,” said Ross Muken, President, SOPHiA GENETICS. “This expanded deployment reflects the growing momentum behind liquid biopsy and our shared ambition to make these technologies more accessible and impactful worldwide.”

Source: SOPHiA GENETICS

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Five projects have received support from the Foundation for Innovation and Technology (FIT) in the form of Tech Grants: Bio-CapnoMAD from CHUV, Helix Robotics, MyJoint and Neurovia from EPFL, and Grenat from HEIG-VD will be able to continue developing their technologies with the backing of the Foundation.

Bio-CapnoMAD provides innovative solutions to fight sleep apnea

Obstructive Sleep Apnea is a widespread disorder affecting approximately one billion people globally, leading to disrupted breathing, poor sleep quality, and increased risks of cardiovascular disease, stroke, and other severe health conditions.
Stemming from CHUV, Bio-CapnoMAD consists of two innovative technologies: bioMAD and capnoMAD. bioMAD relies on a biomimetic design to optimize airway openness by exerting maximum tension on the hyoid bone muscles. capnoMAD, on the other hand, integrates advanced sensor technology to monitor breathing patterns and metabolic status for real-time data collection and personalized adjustments to the treatment plan.
The FIT grant will enable Bio-CapnoMAD to pursue the development and prepare for the next phases, including clinical trials and market readiness.

Helix Robotics creates a soft robotic arm

Spun-out of EPFL, Helix Robotics proposes a soft robotic arm that offers an alternative approach to current rigid collaborative robots that rely on control systems to achieve compliance and safety. This type of robotic manipulators is typically used for tasks like shelf-stacking, manufacturing assistance, social care, and agricultural robotics.
With a soft and compliant physical structure, all the mass (and hence inertia) of the rigid motors is moved to the base. The arm features a continuum bending structure, like an elephant trunk, allowing it to bend, extend, and flex. This enables it to safely operate in close contact with humans and to navigate around, into, and through environments, adapting to and exploiting them.
The FIT-InnoGrant will serve to develop a new version of the arm able to withstand a payload of 3kgs, demonstrate a precision of 4mm, and to demonstrate it for the task of automatic recharging of electric vehicles.

MyJoint: an innovative wearable technology that predicts anterior cruciate ligament injury

In the competitive world of sports, an injury can make or break a team’s success. The EPFL-project MyJoint uses wearable technology and biomechanical modelling backed up by AI analysis to deliver a personalised recommendation based on the different risk factors for each player in a team.
MyJoint’s portable technology estimates dynamic knee valgus loading on the field – a specific parameter responsible for up to 82% of recorded anterior cruciate ligament injuries in football and basketball. The device then identifies the source of increased risk and uses AI and holistic data from the sport team to provide a personalized regime considering multifactorial assessments.
With the FIT-InnoGrant, MyJoint will further develop its platform to integrate existing data and deliver comprehensive performance metrics.

Neurovia: minimally invasive bioelectronic implants to adjust blood pressure

Spun out of EPFL, Neurovia tackles orthostatic hypotension, a disorder that causes blood pressure to drop suddenly when individuals stand up, leaving them vulnerable to falls, fainting, and, in extreme cases, life-threatening complications.
Neurovia’s minimally invasive bioelectronic implant provides real-time, on-demand blood pressure control. Using a stent-like electrode array, the implant is positioned in the renal artery, where it can stimulate nerves to safely and precisely adjust blood pressure as needed.
Made from flexible, biocompatible materials, the device conforms comfortably within the artery, avoiding inflammation and preserving blood flow while ensuring optimal nerve engagement. By offering a customizable solution that activates only when blood pressure needs correcting, Neurovia’s device mitigates the risks associated with constant high or low blood pressure, reducing the likelihood of heart and organ damage over time.
Building on an initial study, the FIT-Innogrant will support key preclinical activities, focusing on terminal porcine model experiments to confirm the implant’s safety and efficacy.

Grenat: an optical sorter for small farms

The Grenat project is an optical sorting technology designed to help farmers sort traditional crops such as pulses or millets. These crops, which were once neglected, have now been identified as essential for adapting to climate change, especially because of their ability to withstand water stress and their high nutritional value.
Grenat offers an innovative technological solution: an optical sorter using a high-resolution camera and a detection system based on artificial intelligence, capable of sorting ancient grains as small as 1 mm in diameter. Unlike existing sorters, which are designed for large farms, the technology is tailored to the specific needs of small-scale producers.
Following a first grant of CHF 50’000 last year, the Grenat project has now been awarded a second Tech Grant of the same amount to pursue the development of its a scalable, adaptable solution designed to transform the value chain of traditional crops, both in Europe and in emerging economies.

Source Text & Photo: FIT

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ONWARD Medical has reached a significant milestone in spinal cord injury (SCI) treatment, receiving FDA de novo classification and U.S. market authorization for its ARC-EX System. This innovative device is the first non-invasive technology approved to improve hand strength and sensation in individuals with chronic SCI, offering hope to a community often told recovery is not possible.

The ARC-EX System delivers programmed electrical stimulation to the spinal cord through external electrodes placed on the back of the neck. Unlike traditional spinal cord stimulation devices, it does not require surgery. This makes it accessible and transformative for individuals with chronic SCI, including those injured decades ago.

Clinical results published in Nature Medicine highlighted the system’s impact: 90% of participants showed improved hand strength or function, while 87% reported enhanced quality of life. Benefits included reduced spasms, better sleep, and improved upper-body sensation. “Regaining hand ability is the highest priority for people with paralysis, and this technology represents a tremendous step forward,” said Dr. Chet Moritz of the University of Washington.

Dave Marver, CEO of ONWARD Medical, described the FDA’s approval as a landmark moment: “For the first time, people with chronic SCI have an authorized therapy that addresses their needs. We hope this is the beginning of many advancements to restore independence.”

The ARC-EX System is currently cleared for clinical use, with home-use authorization expected by mid-2025. ONWARD Medical also plans to expand into Europe, targeting CE Mark certification in late 2025. Beyond ARC-EX, the company is developing other pioneering technologies, including the implantable ARC-IM system and a brain-computer interface (ARC-BCI) powered by artificial intelligence.

About ONWARD Medical

ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).

ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company’s external ARC-EX or implantable ARC-IM platforms. ARC Therapy can also be delivered by the Company’s ARC-BCI platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.

Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease, as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI.

Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland, and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD).

Source: ONWARD Medical PR

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