PETACH TIKVA, Israel - Nanox.AI, a subsidiary of Nanox (NASDAQ:NNOX), has received the U.S. Food and Drug Administration (FDA) 510(k) clearance for its updated cardiac imaging software, HealthCCSng V2.0, the company announced today. The software is designed to enhance coronary artery disease detection and assessment by utilizing routine CT scans.
HealthCCSng V2.0, an AI-driven solution, now includes a 'zero calcium' category to identify patients with no detectable coronary artery calcium (CAC), indicative of a very low risk of cardiac events. This feature complements existing categories that classify CAC levels as low, medium, or high. The software also provides a numerical calcium score, which can be customized by clinicians to refine risk assessments further.
The tool integrates with existing picture archiving and communication systems (PACS) and electronic medical records (EMR), aiming to assist healthcare providers in identifying patients at high risk for coronary artery disease opportunistically. According to the company, those with the highest CAC levels are significantly more likely to experience a cardiac event.
Erez Meltzer, CEO of Nanox, expressed the company's commitment to equipping healthcare professionals with effective tools for preventative care. He highlighted the AI solution's potential to bridge the gap between radiology and cardiology, facilitating the identification of at-risk patients who may otherwise be overlooked.
Nanox.AI's technology is part of a broader effort by Nanox to democratize access to medical imaging and improve early disease detection and treatment. The company's ecosystem also includes the Nanox.ARC digital tomosynthesis system, a cloud-based infrastructure, and a decentralized marketplace offering remote access to radiology and cardiology expertise.
This advancement is based on a press release statement from Nano-X Imaging LTD.
In other recent news, Nano-X Imaging Limited reported its Q2 2024 financial results, which included a reduced GAAP net loss of $13.6 million, down from last year's $17.4 million for the same period. The company's revenue for the quarter was $2.7 million, despite a gross loss of $2.9 million. These developments are part of Nano-X's ongoing efforts to expand its product offerings, notably the forthcoming Nanox.ARC X system, and secure several regulatory approvals, including a new FDA submission and a pending CE Mark for the EU region.
Nano-X's recent progress also includes installations in three major U.S. healthcare chains and an increased manufacturing capacity in Israel. The company is awaiting state approvals in Delaware and California and an import license for Mexico. It is also making strides with the Nanox.AI cardiac solution, which recently received recognition at a scientific meeting.
Looking ahead, Nano-X plans a production ramp-up for 2025, facilitated by a low-cost manufacturing arrangement. The company also plans to expand its U.S. sales force and use distributors in countries outside the U.S., Israel, and the UK. These are the latest developments in Nano-X Imaging Limited's ongoing efforts to enhance its position in the medical imaging field.
InvestingPro Insights
Nanox (NASDAQ:NNOX), a pioneer in medical imaging technology, recently celebrated a milestone with FDA clearance for its cardiac imaging software. As investors consider the implications of this development for the company's financial health and stock performance, certain metrics and tips from InvestingPro provide deeper insights.
InvestingPro Data shows that Nanox has a market capitalization of $417.08 million, reflecting the company's current valuation in the market. Despite challenges such as weak gross profit margins, indicated by a gross profit of -$7.12 million over the last twelve months as of Q1 2023, Nanox holds more cash than debt on its balance sheet, which could provide a cushion for operational needs and investment in further innovation.
Two InvestingPro Tips for Nanox highlight the company's financial position and market performance:
1. Nanox's liquid assets exceed its short-term obligations, suggesting a stable financial footing in the near term.
2. The stock price has been quite volatile, with a 1-year price total return of -16.07%, which could indicate higher risk for investors seeking stable returns.
It's also worth noting that analysts do not anticipate Nanox to be profitable this year, and the company does not pay a dividend to shareholders, which may influence investment decisions depending on individual risk appetites and income preferences.
For investors interested in a more comprehensive analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/NNOX, which could provide further guidance on the potential risks and opportunities associated with Nanox's stock.
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