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Elekta Wins FDA Nod for Evo CT-Linac, Boosting U.S. Radiation Oncology
ZACKS· 2026-01-19 18:41
Core Insights - Elekta's Evo CT-Linac has received FDA 510(k) clearance, enabling its use in radiation oncology across the U.S. [1][8] - The FDA clearance is a pivotal part of Elekta's strategy to enhance its presence in the U.S. market, promoting personalized and precise radiation therapy [2][4] - The stock price of EKTAY increased by 3.7% following the announcement, with a 38.4% rise over the past six months, outperforming the industry and S&P 500 [3] Company Developments - The Evo CT-Linac's FDA approval allows for commercialization in the U.S., expanding Elekta's market in radiation oncology [4] - The system's advanced imaging and AI capabilities are expected to improve operational efficiency and support revenue growth through increased adoption in clinics [2][4] - Elekta is implementing a new operating model aimed at accelerating product development and enhancing operational efficiency, projected to save at least SEK 500 million annually [13] Product Features - Evo CT-Linac integrates high-quality CT imaging with linear accelerator functionality, enhancing tumor visualization during treatment [1][9] - The Iris imaging technology, which is AI-driven, minimizes scatter and improves image clarity, aiding clinicians in making better treatment decisions [10][11] - The system is designed for easy upgrades to existing Elekta linear accelerators, facilitating adoption and extending system life [10] Market Outlook - The radiation therapy market is projected to reach $8.64 billion by 2026, with a CAGR of 9% through 2035, driven by rising cancer patient numbers and technological advancements [12]
HOLX vs. LH: Which MedTech Stock Is the Stronger Investment Now?
ZACKS· 2025-12-22 14:01
Core Insights - Hologic and Labcorp are established players in the MedTech sector, each with unique strengths and market capitalizations of $16.71 billion and $20.89 billion respectively [1] Group 1: Hologic - Hologic's largest revenue segment is Diagnostics, driven by the Molecular Diagnostics unit, particularly the BV, CV/TV assay, which has become a major contributor to U.S. performance [3] - The Panther Fusion add-on module is gaining traction, with features like Open Access functionality allowing labs to run their own tests, and new FDA and CE-IVDR-approved assays diversifying the testing menu [4] - Hologic's acquisition of Biotheranostics in 2021 accelerated its entry into oncology, while innovations in breast health, such as AI-powered mammography solutions, are gaining clinical momentum [5] - Gynesonics enhanced the GYN Surgical product lineup with the Sonata System technology, and international market share for Myosure is increasing, indicating unmet demand for minimally invasive options [6] Group 2: Labcorp - Labcorp is executing a solid strategy focused on partnerships with health systems and laboratories, enhancing its market presence and access to a broad test menu [7] - The company is experiencing strong growth in specialty areas like oncology, women's health, and neurology, driven by scientific advancements and innovation [8] - Notable capabilities include HRD testing, FDA-cleared blood-based tests for Alzheimer's, and the Labcorp Plasma Complete liquid biopsy test, contributing to its growth [9] - Labcorp is investing in digital and AI capabilities to improve operational efficiency and aims for annual savings of $100-$125 million under the LaunchPad initiative [11] Group 3: Performance and Valuation - Both companies have underperformed compared to the S&P 500 over the past 12 months, but Labcorp has shown better resilience [12] - Hologic has a forward one-year price-to-sales (P/S) ratio of 3.86, while Labcorp's is significantly lower at 1.43, indicating a more favorable valuation for Labcorp [13] - Analyst price targets suggest a 2.6% upside for Hologic, with an average target of $76.92, while Labcorp has a 19.3% upside potential with a target of $300.71 [15][18] Group 4: Conclusion - Both companies hold a Zacks Rank 3 (Hold), with Hologic's strengths in Diagnostics and Breast Health and Labcorp's focus on partnerships and high-growth areas positively impacting their performance [20] - Labcorp is positioned as the stronger investment option based on valuation, price performance, and analyst targets compared to Hologic [20]
Nanox Engages with Althea France to Accelerate European Commercialization of Nanox.ARC System
Globenewswire· 2025-11-25 13:10
Core Insights - Nanox Imaging Ltd has entered into a distribution agreement with Althea France to introduce its CE-marked Nanox.ARC system in the French healthcare sector, marking its fourth distribution agreement in Europe [1][2][3] Company Overview - Nanox is focused on advancing medical imaging technology, aiming to drive the transition to preventive healthcare through affordable solutions that leverage AI and proprietary digital X-ray sources [4][5] Partnership Details - Althea France will manage the market introduction, sales, and service of the Nanox.ARC, which is a multi-source digital tomosynthesis system designed to enhance diagnostic capabilities at a lower cost compared to traditional systems [2][3] - The partnership is expected to leverage Althea's established relationships with hospitals and clinics across France, facilitating the introduction of Nanox's imaging platform [3] Market Strategy - France is identified as a strategic market for Nanox, with the partnership expected to expand access to high-quality, affordable imaging services for patients [3] - The collaboration follows previous agreements in Greece, Romania, and the Czech Republic, indicating a growing presence in the European market [1][2]
Nano-X Imaging (NNOX) - 2025 Q3 - Earnings Call Transcript
2025-11-20 14:32
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.7 million for Q3 2025, compared to a net loss of $13.6 million in Q3 2024 [31] - Revenue for Q3 2025 was $3.4 million, an increase from $3.0 million in the comparable period [31] - Non-GAAP gross loss for the reported period was $0.3 million, compared to a gross loss of $0.2 million in the comparable period, representing a gross loss margin of approximately 8% [32] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for Q3 2025 was $3.1 million, with a gross profit of $0.1 million, compared to revenue of $2.6 million and a gross profit of $0.3 million in the comparable period [32] - Revenue from the sale and deployment of imaging systems and OEM services amounted to $175,000 for the reported period, with a gross loss of $1.7 million [35] - Revenue from AI solutions for the reported period was $0.1 million, with a gross loss of $1.9 million [35] Market Data and Key Metrics Changes - The company is expanding its presence in Europe with new agreements in the Czech Republic and France, indicating rising demand for its imaging ecosystem [7][15] - The company aims to deploy 100 systems worldwide by the end of 2025, with several systems pending regulatory approval [7] Company Strategy and Development Direction - The company is focused on building a comprehensive medical imaging portfolio, reinforcing its position in the medical AI sector, and deepening its foothold in the U.S. healthcare system [4][5] - The acquisition of VasoHealthcare IT is intended to enhance customer service and expand the company's operational capabilities [10][22] - The company is preparing to launch the next-generation Nanox.ARC X system, which is designed to meet diverse clinical needs and expand the addressable market [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over $35 million in revenues for 2026, driven by strategic partnerships and the acquisition of VasoHealthcare IT [5][39] - The company anticipates that the AI business segment will achieve EBITDA break-even on a quarterly basis in 2026, while the overall company aims for break-even in 2027 [30][62] Other Important Information - The company has a strong presence planned at the RSNA annual meeting, where it will provide insights into its commercial progress and future strategy [13][21] - The company is actively engaged in clinical trials to support the use of its solutions in lung cancer detection and management [18][20] Q&A Session Summary Question: How many systems were in the field and performing scans that resulted in your revenue of $175,000? - The CEO mentioned that a few dozen systems were deployed, with some pending installation and regulatory approvals [44] Question: What types of agreements should we be thinking about in terms of those being lease versus capital sales? - The CFO indicated that the majority of agreements are expected to be MSES, with some CapEx sales anticipated [48] Question: Could you talk about how OpEx could look over the next four to six quarters? - Management indicated that sales and marketing expenses will increase due to deployment efforts, while R&D expenses will be more controlled [56] Question: Could you talk about Vaso and the types of customers they currently have? - The CEO stated that Vaso's customers are primarily medical-related, serving hospitals and imaging centers, presenting cross-selling opportunities [58] Question: Could you reiterate the break-even expectations for the AI business and ARC division? - Management reiterated that the AI business is expected to reach quarterly break-even in 2026, while the ARC division aims for break-even in 2027 [60][62]
QT Imaging(QTI) - Prospectus
2025-11-03 22:22
As filed with the U.S. Securities and Exchange Commission on November 3, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 QT Imaging Holdings, Inc. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code No.) Delaware 6770 85-1728920 (I.R.S. Employer Identification No.) Dr. Raluca Din ...
Perimeter Showcases Innovative Imaging Technology at Aptitude Health/TME's Fall Summit on Breast Cancer Care
Prnewswire· 2025-09-26 12:00
Core Insights - Perimeter Medical Imaging AI, Inc. is participating in the "Take the Lead in Breast Cancer Care" summit, which gathers leading breast cancer physicians to discuss advancements in patient care [1][3] - The company's S-Series OCT technology, which received FDA clearance in 2021, allows surgeons to visualize margins during surgery, and an AI-assisted version is currently under FDA evaluation [2][4] Company Overview - Perimeter Medical Imaging AI is based in Toronto and Dallas, focusing on transforming cancer surgery with advanced imaging tools that provide real-time, ultra-high-resolution visualization of excised tissues at the cellular level [4] - The Perimeter S-Series OCT system is FDA-cleared and available across the U.S., while the investigational Perimeter B-Series OCT with ImgAssist AI is undergoing a pivotal clinical trial supported by a grant of up to US$7.4 million from the Cancer Prevention and Research Institute of Texas [4][5] Industry Context - The summit features multi-disciplinary discussions among surgeons, oncologists, pathologists, and genetic specialists, aimed at exploring innovative diagnostics and therapeutic discoveries to improve patient outcomes [3]
Perimeter's Advanced Imaging Technology Featured at Annual Clinical Assembly of Osteopathic Surgeons
Prnewswire· 2025-09-19 12:00
Core Insights - Perimeter Medical Imaging AI, Inc. is showcasing its S-Series OCT technology for real-time margin visualization during breast conserving surgery at the 2025 Annual Clinical Assembly [1][2][3] Company Overview - Perimeter Medical Imaging AI is a commercial-stage medical technology company based in Toronto and Dallas, focused on transforming cancer surgery with advanced imaging tools [4] - The S-Series OCT system has received FDA clearance in 2021 and provides real-time, cross-sectional visualization of excised tissues at the cellular level [4] - The investigational Perimeter B-Series OCT with ImgAssist AI is currently under evaluation in a pivotal clinical trial, supported by a grant of up to US$7.4 million from the Cancer Prevention and Research Institute of Texas [4] Technology and Application - Dr. Amelia Tower's presentation emphasizes the importance of advanced imaging technologies like the S-Series OCT in reducing re-excision rates and enhancing surgical precision [3][2] - The S-Series OCT allows surgeons to visualize disease at the cellular level in real-time, potentially reducing the stress and delays associated with re-excisions [3] Event Participation - The 2025 Annual Clinical Assembly, sponsored by the American College of Osteopathic Surgeons, gathers over 1,200 multi-disciplinary surgeons for networking and continuing medical education [3]
Nanox Announces Multi-Segment Healthcare Collaboration with Monarch Medical Management to Expand Access to Advanced Medical Imaging
Globenewswire· 2025-09-18 12:00
Core Insights - Nanox Imaging Ltd has announced a collaboration with Monarch Medical Management and Billing LLC to deploy advanced imaging solutions across various healthcare segments, including workers' compensation, nursing homes, and outpatient clinics [1][2][4] Group 1: Collaboration Details - The collaboration aims to establish a comprehensive imaging network by deploying Nanox's technology across Monarch's associated healthcare facilities, with over a dozen initial sites identified for a proof-of-concept phase [2] - Nanox's advanced imaging services will be accessible to patients in multiple care settings, including the Nanox.ARC system, AI-powered software for analyzing CT scans, and teleradiology services [3][4] Group 2: Strategic Goals - The collaboration addresses critical imaging access challenges by providing faster access to high-quality imaging services, which can accelerate accurate diagnosis and treatment decisions for patients [4] - Nanox's vision includes expanding its technology reach beyond hospital settings, aiming for a seamless end-to-end solution from scan to diagnosis, leveraging AI for improved efficiency in medical imaging [6] Group 3: Company Background - Nanox is focused on transitioning the world to preventive healthcare through affordable medical imaging technologies based on advanced AI and proprietary digital X-ray sources [5] - The Nanox ecosystem includes various components such as Nanox.ARC, Nanox.AI, Nanox.CLOUD, and Nanox.MARKETPLACE, all aimed at enhancing early detection and treatment to improve health outcomes globally [6]
Izotropic Prepares New Platforms to Educate and Engage
Newsfile· 2025-07-15 12:00
Core Insights - Izotropic Corporation is initiating strategic awareness initiatives in anticipation of the commercialization of its IzoView Breast CT Imaging System, which aims to enhance breast cancer screening and diagnosis [1][2]. Group 1: Awareness Campaign - The awareness efforts will focus on educating global audiences about the transformative value of dedicated breast CT technology, highlighting IzoView's unique features and competitive advantages [2][5]. - The campaign will incorporate emerging trends in breast imaging, regulatory frameworks, and market growth forecasts to contextualize IzoView's potential [2]. Group 2: Communication Channels - Izotropic will launch a podcast series to discuss company news and milestones, providing timely commentary on corporate updates and relevant developments in the breast imaging sector [3]. - A dedicated online platform, breastct.com, will be introduced to feature articles about breast CT technology and the company's progress, evolving into a comprehensive educational resource over time [4]. Group 3: Strategic Alignment - The awareness strategy is developed in collaboration with Izotropic's capital markets and industry advisory team, focusing on aligning investor engagement and communications with long-term regulatory and commercialization objectives [5].