<div>
  <ul>
    <li>
      <p>
        Clinical trial management platform provider Huma has received 510(k) Class II FDA clearance for its configurable disease-agnostic platform, including its cardiovascular risk score algorithm. The company received this FDA clearance in partnership with Health Canada and it allows Huma's platform to be used to monitor patients of all ages with any condition, including pediatrics and pregnancy. The Class II clearance also enables the platform to host algorithms that provide automated AI-driven data analytics for diagnosis, screening, clinical decision-making, predictions on health outcomes, and recommendations on dosage.
      </p>
    </li>
    <li>
      <p>
        Huma&rsquo;s platform allows patient data to be collected and managed remotely by providers and includes companion apps for remote patient monitoring and disease management. The platform is designated as a Software as a Medical Device platform and is device agnostic, allowing it to integrate with third-party devices such as heart rate and blood sugar monitors and smart inhalers.
      </p>
    </li>
  </ul>
  <p>
  </p>
</div>


<div>
  <p>
    <a href="https://www.huma.com/resources/us-fda-510k-classii-regulatory-clearance-configurable-samd-disease-management">
      Company press release
    </a>
  </p>
  <p>
    <a href="https://www.mobihealthnews.com/news/huma-receives-510k-class-ii-clearance-its-disease-agnostic-platform">
      Mobi Health News
    </a>
  </p>
  <p>
  </p>
</div>


Clinical Trial Technology

Huma receives 510(k) Class II FDA clearance for disease-agnostic platform

Additive manufacturing makes objects by systematically adding material via a CAD program

Additive Manufacturing

INCUMBENTS_PRESENT

PROMINENT_CATEGORY

<div>
 <p>Hexagon's Manufacturing Intelligence division, a leading provider of manufacturing technology solutions, has unveiled its latest innovation, the Advanced Compensation technology specifically designed for metal 3D printing. The novel technology is anticipated to be available to all existing Simufact Additive customers starting from the first quarter of 2025.</p>
 <p>The distinctive aspect of this technology is its potential to blend process simulation with geometry compensation which is vital in guaranteeing that large or intricate metal parts deform into their predefined shape during the printing process. The cutting-edge solution is compatible with Hexagon's Simufact Additive software and VGSTUDIO MAX technology. This integration equips users with the capability to perform actions on parts and compensate print-ready meshes with the help of 3D scan data. Based on the information provided by Hexagon, the introduction of the new technology will empower manufacturers to attain surface profiles that are between 98% and 100% within the acceptable tolerance range. Other projected benefits of the technology include reduction in material waste and a decrease in support structures.</p>
</div>

Hexagon unveils Advanced Compensation for metal 3D printing

Empowering Tomorrow's Innovations with Generative AI Infrastructure

Generative AI Infrastructure

<div>
 <p>Eden AI, an artificial intelligence (AI) integration platform, secured seed funding worth approximately USD 3.1 million. The investment round was spearheaded by Galion.exe and saw participation from angel investors such as Olivier Pomel, Sébastien Pahl, and Alix de Sagazan, as well as 50 Partners.</p>
 <p>The funds are set to be utilized for speedier product development, the expansion of the engineering team, growing the partner ecosystem, and the enhancement of workflow capabilities. Moreover, the investment will also be used to build monitoring and analytics tools for their centralized dashboard.</p>
 <p>The company offers a centralized platform which allows businesses to access and merge AI models from renowned providers like Google, AWS, and OpenAI. With its unified API, Eden AI supports natural language processing, computer vision, and GenAI. This characteristic allows users to construct, launch, and scale custom AI workflows using only a single endpoint.</p>
</div>

Eden AI raises EUR 3 million in seed funding to accelerate product development

AI-based solutions for evolving digital threats

Next-gen Cybersecurity

<div>
 
 <p>Cloud security company, Wiz, has acquired Dazz, a provider of cloud security remediation platforms for an undisclosed sum. </p>
 <p>The acquisition seeks to integrate Wiz's Cloud Native Application Protection Platform (CNAPP) and Application Security Posture Management (ASPM) with Dazz's remediation solutions, enhancing handling, prioritizing, and addressing of cloud security issues effectively for customers.</p>
 <p>Dazz is known for its specialization in cloud security remediation and has evidenced significant growth with a 300% Year on Year growth in new annual contract value. The firm has completed several seven-figure deals with Fortune 100 and Fortune 500 clients from various sectors including financial, healthcare, and tech industries.</p>
 
</div>

Wiz acquires Dazz to expand cloud security remediation capabilities

A decentralized version of the web powered by the blockchain

Web3 Ecosystem

<div>
 
 <p>Immutable, a blockchain-based video games developer and Web3 development platform provider, has entered a partnership with Altura, a Web3 infrastructure provider. This partnership aims to enhance Web3 game development and marketplace solutions.</p>
 <p>As part of the partnership, Immutable's Passport and Checkout infrastructure have been integrated into Altura's marketplace solution. This integration offers game developers access to bulk minting capabilities, asset tracking, and a direct integration with Immutable zkEVM. The partnership will enable games developed on Altura to participate in the Main Quest program, a scheme that rewards player engagement across different titles.</p>
 <p>Furthermore, Altura has contributed up to USD 5 million to Immutable's zkEVM Main Quest Program.</p>
 
</div>

Immutable partners with Altura to enhance Web3 game development and marketplace solutions

Leveraging personal data for custom-fit diagnosis and treatment

Precision Medicine

<div>
 
 <p>OneCell Diagnostics, a genomics-based company specializing in blood-based biopsy testing for cancer recurrence, has successfully raised USD 16 million in a Series A fundraising round. The round was led by Celesta Capital and saw participation from Tenacity Ventures, Cedars Sinai, Eragon, and Singularity Ventures.</p>
 <p>The company has plans to use the raised funds to enhance precision oncology and provide accessible and affordable cancer diagnostic tests. In addition to this, OneCell Diagnostics is also planning to enter the US market with OncoIndx Ikon, its next-generation liquid biopsy test.</p>
 <p>OneCell Diagnostics' proprietary True-Single-Cell-Multi-omics platform analyzes circulating tumor cells from a small blood sample of just 10 ml. The company provides pan-cancer analysis for all solid tumors including breast, lung, and colon cancers, with a specific focus on patients with recurrent cancer. Furthermore, the company has developed OncoIndx Ikon, a test designed to detect and analyze circulating tumor cells.</p>
 
</div>

OneCell Diagnostics raises USD 16 million in Series A funding to enhance cancer diagnostics

<div>
 
 <p>BioLineRx has formed a licensing deal with Ayrmid, Gamida Cell's parent company, to develop and commercialize the FDA-approved stem-cell mobilization agent, APHEXDA (motixafortide). BioLineRx will receive a USD 10 million upfront payment, potential commercial milestone payments up to USD 87 million, and royalties from 18% to 23% on net sales.</p>
 <p>In this deal, Ayrmid gets exclusive rights to develop and commercialize APHEXDA for all indications, barring solid tumor indications, and in all regions excluding Asia. BioLineRx will persist in developing motixafortide for solid tumors by leveraging its expertise in drug development.</p>
 <p>BioLineRx, based in Israel, is a biopharmaceutical company that focuses on creating therapies for oncology and rare diseases. Its product APHEXDA (motixafortide) acts as a CXCR4 antagonist with long receptor occupancy exceeding 72 hours. BioLineRx is also furthering motixafortide in clinical trials for other indications such as pancreatic cancer and sickle-cell disease.</p>
 
</div>

BioLineRx and Ayrmid partner to license and commercialize APHEXDA across multiple indications

ANALYST_QUICK_TAKE

<div>
 
 <p>The global introduction of the latest application, MSK-IMPACT, created with SOPHiA DDM, has been announced by SOPHiA GENETICS. This product enables companies across the globe to use the comprehensive genomic profiling (CGP) application of the Memorial Sloan Kettering Cancer Center on the SOPHiA DDM platform.</p>
 <p>By providing increased accuracy in identifying somatic mutations connected to the current pharmaceutical industry R&amp;D pipelines, MSK-IMPACT optimises oncology analyses. Its matched tumour-normal analysis approach is geared towards assisting medical practitioners to recognise somatic mutations with higher confidence and prevent confusion of germline variants as tumour-specific. It is anticipated that this recent launch will make advanced tumour profiling technology more widely accessible internationally.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> The SOPHiA DDM platform received the CE marking under the EU's In Vitro Diagnostic Regulation in <a href="https:<br>
//sp-edge.com/updates/32655"> August 2024 </a> , a key regulatory requirement when expanding to international markets, including the EU and other markets recognizing this certification. The platform reportedly includes five existing CE-IVD applications and a global network of partners for collective intelligence.</p>

SOPHiA GENETICS announces global launch of MSK-IMPACT powered with SOPHiA DDM

<div>
 
 <p>Biofidelity has initiated the Aspyre Clinical Test for Lung, a genomic evaluation test targeting non-small-cell lung cancer genes from tissue and blood specimens. This test is now active for clinical practice through their lab services.</p>
 <p>The Aspyre test identifies somatic mutations from DNA and gene unions directly from RNA in tissue and blood specimens. This test offers results in two days, scans all suggested genes for non-small-cell lung cancer patients, and can handle challenging specimens.</p>
 <p>The company states that the major advantages of the test are next-day turnaround time, compatibility with both tissue and blood specimens, and eradication of the requirement for distinct tests, consequently reducing further sample requirements and costs. The firm aims to reveal supporting clinical performance statistics at the International Society of Liquid Biopsy Annual Meeting 2024.</p>
 
</div> <p><b>Analyst QuickTake:<br>
</b> In <a href="https:<br>
//sp-edge.com/updates/28192"> April 2024 </a> , Biofidelity raised USD 24 million in venture funding to fast-track the adoption of the ASPYRE-Lung test for NSCLC. The funds were also directed toward supporting commercial and clinical expansion in the US, establishing a manufacturing facility in the UK, and enhancing its existing technology platforms.</p>

Biofidelity launches Aspyre Clinical Test for lung cancer detection

Platforms, apps, and cards to keep the corporate wallet in check

Business Expense Management

<div>
 <p>Spendesk, a spend management platform, has joined forces with Adyen, a fintech platform, to capitalize on Adyen's banking-as-a-service capabilities across several markets. The collaboration will utilize Adyen's banking licenses in the UK, US, and EU, giving Spendesk the opportunity to amplify its payment solution offerings. These include digital wallets, streamlined client onboarding, and boosted payment processing.</p>
 <p>The partnership is part of Spendesk's 2025 plan to speed up new product developments while ensuring regulatory compliance in its areas of operation. The ultimate goal is to revamp spend management workflows for small and medium-sized businesses (SMBs). This will be achieved by increasing visibility in the payment process, adding flexible payment options, and enhancing operational efficiency.</p>
</div> <p><b>Analyst QuickTake</b> :<br>
 This partnership builds on Spendesk's recent launch of its procurement and spend management tool for European SMBs in <a href="https:<br>
//sp-edge.com/updates/35131"> October 2024. </a> Adyen is based in the Netherlands and holds banking licenses across Europe, so the collaboration is expected to support Spendesk in expanding its operations and activities within the region.</p>

Spendesk partners with Adyen to enhance SMB spend management with banking-as-a-service solution

Travel Tech

<div>
 <p>Mews, a hospitality platform provider, recently purchased Atomize, a software company based in Sweden that specializes in revenue management. The intention behind this acquisition is to augment the features of the Mews cloud-based system for hospitality. This will happen through the inclusion of Atomize's capabilities to provide market data and predictive insights, thus allowing those in the hotel industry to make decisions based on real-time information and to enhance revenue-earning potential in a more effective manner.</p>
 <p>Established in 2016, Atomize offers solutions in hotel prediction and real-time dynamic pricing. With a focus on turning complex market information into applicable insights, its platform is used in over 50 countries across five continents. The range of properties it serves spans from hotels with a capacity of 50 rooms to those that can accommodate 1,250 guests.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> Mews has adopted a strategic acquisition approach to expand its geographic presence and diversify its product portfolio. In <a href="https:<br>
//sp-edge.com/updates/35658"> November 2024, </a> the company acquired Quotelo, a French event management platform, to enhance its R&amp;D capabilities. In <a href="https:<br>
//sp-edge.com/updates/29443"> May 2024, </a> Mews strengthened its presence in Germany by acquiring HS3 Hotelsoftware.</p>

All Updates

Huma receives 510(k) Class II FDA clearance for disease-agnostic platform

Hexagon unveils Advanced Compensation for metal 3D printing

Eden AI raises EUR 3 million in seed funding to accelerate product development

Wiz acquires Dazz to expand cloud security remediation capabilities

Immutable partners with Altura to enhance Web3 game development and marketplace solutions

OneCell Diagnostics raises USD 16 million in Series A funding to enhance cancer diagnostics

BioLineRx and Ayrmid partner to license and commercialize APHEXDA across multiple indications

SOPHiA GENETICS announces global launch of MSK-IMPACT powered with SOPHiA DDM

Biofidelity launches Aspyre Clinical Test for lung cancer detection

Spendesk partners with Adyen to enhance SMB spend management with banking-as-a-service solution

Mews acquires Swedish RMS provider Atomize to enhance Hospitality Cloud platform

Clinical Trial Technology

Huma receives 510(k) Class II FDA clearance for disease-agnostic platform

Contact us