DALLAS, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) ("Spectral AI" or the "Company"), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the completion of enhancements to its technical file to support significant software updates for its DeepView SnapShot M and DeepView AI-Burn system in the UK. These upgrades, informed by real-world experience and frontline feedback from clinicians, are designed to enhance product performance and usability in the UK, further solidifying the Company's commitment to delivering and commercializing cutting-edge solutions in critical care settings.
This regulatory milestone ensures Spectral AI can implement the updated software on its DeepView SnapShot M and AI-Burn systems currently deployed in the UK, where the devices are authorized as two separate products. The enhanced software reflects invaluable input from frontline users, enabling improvements in diagnostic accuracy, workflow integration, and patient care. These updates represent Spectral AI's dedication to incorporating direct clinician feedback into its technology, ensuring it meets the demands of real-world healthcare environments.
The formal enhancement to the technical file also assists Australian burn centers as Spectral AI is operating under the country's unique access program, the Approved Prescriber Program. This move ensures that Australian healthcare providers will be provided with access to Spectral AI's most advanced diagnostic technology.
Dr. J. Michael DiMaio, Chairman of the Board at Spectral AI, said, "The regulatory status of our products in the UK is essential, as both hospital ethics committees and the Therapeutic Goods Administration (TGA) in Australia rely on UK authorization and technical file documentation to support the use of our devices. These upgrades reflect our commitment to continuous improvement, ensuring our technologies deliver optimal outcomes for clinicians and patients alike. As we get additional feedback from real-world usage, we will continue to improve DeepView's performance and impact on patient care. The feedback from the UK has been extremely encouraging and affirms my belief that DeepView can contribute significantly to enhanced patient care in the UK and other countries."
With these enhancements, Spectral AI continues to lead the way in AI-driven wound diagnostics, integrating real-world insights to meet clinicians' complex needs and improve patient outcomes.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize wound care management by "Seeing the Unknown" with its DeepView System. DeepView is a predictive device that offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight toward value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, visit .
Forward-Looking Statements
Certain statements made in this release are "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company's intention to separate its Spectral IP subsidiary from the Company, and each Company's strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.
These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company's control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" sections of the Company's filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Spectral AI undertakes no obligation to update any forward-looking statements except as otherwise required by law.
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ダラス、2024年12月09日 (グローブニュースワイヤー) -- Spectral AI (ナスダック: MDAI) ("Spectral AI" または "会社" ) は、医療診断を革命的に変え、創傷ケアにおける迅速かつより正確な治療決定を可能にすることに焦点を当てた人工知能 (AI) 会社であり、本日、UKにおけるDeepView SnapShot mおよびDeepView AI-Burnシステムの重要なソフトウェア更新をサポートするための技術ファイルへの改良が完了したことを発表しました。これらのアップグレードは、実際の経験と臨床医からの最前線のフィードバックに基づいており、UKにおける製品のパフォーマンスと使いやすさを向上させるように設計されています。これにより、会社の重要なケア環境での最先端ソリューションの提供と商業化へのコミットメントがさらに強化されます。
この規制上のマイルストーンは、Spectral AIがUKで現在展開されているDeepView SnapShot mおよびAI-Burnシステムに更新されたソフトウェアを実装できることを保証し、これらのデバイスは2つの別々の製品として承認されています。強化されたソフトウェアは、最前線のユーザーからの貴重な入力を反映しており、診断の正確性、ワークフローの統合、および患者ケアの改善を可能にします。これらの更新はSpectral AIの直接的な臨床医のフィードバックをテクノロジーに取り入れるという献身を示し、実際の医療環境の要求に応えることを確実にします。
技術ファイルの正式な改良は、Spectral AIが豪州の独自のアクセスプログラムである承認処方者プログラムの下で運営されているため、豪州の火傷センターにも役立ちます。この動きにより、豪州の医療提供者がSpectral AIの最も進んだ診断テクノロジーへのアクセスを得られることが保証されます。
Spectral AIの取締役会の会長であるJ. マイケル・ディマイオ博士は、"UKにおける当社の製品の規制上の地位は重要です。なぜなら、病院の倫理委員会と豪州の治療品管理局 (TGA) は、当社のデバイスの使用をサポートするためにUKの承認と技術ファイル文書に依存しているからです。これらのアップグレードは、臨床医と患者の最適な成果を確保するために、当社のテクノロジーが持続的に改善されるというコミットメントを反映しています。実際の使用からのフィードバックを受け取り次第、DeepViewのパフォーマンスと患者ケアへの影響を継続的に向上させていきます。UKからのフィードバックは非常に励みになり、DeepViewがUKやその他の国における患者ケアの向上に大きく貢献できるという私の信念を確かなものにしています。"
これらの強化により、Spectral AIは人工知能駆動の創傷診断で先駆けとなり、現実世界の洞察を統合して臨床医の複雑なニーズに応え、患者の結果を改善しています。
Spectral AIについて
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize wound care management by "Seeing the Unknown" with its DeepView System. DeepView is a predictive device that offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight toward value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, visit .
将来を見通す記述
Certain statements made in this release are "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company's intention to separate its Spectral IP subsidiary from the Company, and each Company's strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.
これらの前向きな見通しに関する声明は、将来の業績、条件、結果を保証するものではなく、多数の既知のリスク、不確実性、前提条件、およびその他の重要な要因、これらのほとんどは同社の制御の外にあり、実際の結果や成果が前向きな見通しに関する声明と異なる可能性があることを示唆しています。これらの前向きな見通しに頼らずに、読者は慎重に行動し、個々の場合において適切と思われるリスクや不確実性を検討すべきです。
投資家は、前述の要因及び会社がSECに提出した「リスク要因」セクションに記載されているその他のリスクや不確実性を慎重に考慮するべきです。これらの提出書類は、実際の出来事や結果が先行き見通しの記載と実質的に異なる原因となる可能性がある他の重要なリスクや不確実性を特定し、対処しています。Spectral AIは、法律で要求されない限り、いかなる先行き見通しの記載を更新する義務を負いません。
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