Ynvisible Delivers E-Paper Displays for At-Home Medical Tests, Supporting the FDA Approval Process
Ynvisible Interactive has delivered over 10,000 customized e-paper displays to a leading diagnostics company for integration into novel at-home medical diagnostic tests currently under FDA review. The displays, developed to meet strict medical industry requirements, are expected to help increase the customer's market share due to their cost-effectiveness and energy efficiency. The global at-home diagnostic testing market, valued at USD 12.73 billion in 2023, is projected to reach USD 22.1 billion by 2030, growing at a CAGR of 8.2%. The FDA's 510(k) review process typically takes around 90 days to complete.
Ynvisible Interactive ha fornito oltre 10.000 display a inchiostro elettronico personalizzati a una importante azienda di diagnostica per l'integrazione in nuovi test diagnostici medici domestici attualmente in fase di revisione da parte della FDA. I display, sviluppati per soddisfare rigorosi requisiti dell'industria medica, si prevede che contribuiranno ad aumentare la quota di mercato del cliente grazie alla loro convenienza economica ed efficienza energetica. Il mercato globale dei test diagnostici domestici, valutato 12,73 miliardi di USD nel 2023, dovrebbe raggiungere 22,1 miliardi di USD entro il 2030, con una crescita CAGR dell'8,2%. Il processo di revisione 510(k) della FDA di solito richiede circa 90 giorni per essere completato.
Ynvisible Interactive ha entregado más de 10,000 pantallas de papel electrónico personalizadas a una importante empresa de diagnósticos para su integración en novedosas pruebas diagnósticas médicas en casa que actualmente están bajo revisión de la FDA. Las pantallas, diseñadas para cumplir con estrictos requisitos de la industria médica, se espera que ayuden a aumentar la cuota de mercado del cliente debido a su rentabilidad y eficiencia energética. El mercado global de pruebas diagnósticas en casa, valorado en 12.73 mil millones de USD en 2023, se proyecta que alcanzará 22.1 mil millones de USD para 2030, creciendo a una tasa de crecimiento anual compuesta (CAGR) del 8.2%. El proceso de revisión 510(k) de la FDA generalmente toma alrededor de 90 días para completarse.
Ynvisible Interactive는 현재 FDA 검토 중인 새로운 가정용 의료 진단 테스트에 통합하기 위해 주요 진단 회사에 맞춤형 전자 종이 디스플레이를 10,000개 이상 제공했습니다. 의료 산업의 엄격한 요구 사항을 충족하기 위해 개발된 이 디스플레이는 비용 효율성과 에너지 효율성 덕분에 고객의 시장 점유율을 증가시키는 데 도움이 될 것으로 예상됩니다. 2023년 127억 3천만 달러로 평가된 글로벌 가정용 진단 테스트 시장은 2030년까지 221억 달러에 이를 것으로 예상되며, 연평균 성장률(CAGR)은 8.2%에 이를 것입니다. FDA의 510(k) 검토 과정은 보통 완료하는 데 약 90일이 소요됩니다.
Ynvisible Interactive a livré plus de 10 000 écrans en papier électronique personnalisés à une entreprise de diagnostic de premier plan pour leur intégration dans de nouveaux tests de diagnostic médical à domicile actuellement sous examen par la FDA. Les écrans, conçus pour répondre à des exigences strictes de l'industrie médicale, devraient aider à accroître la part de marché du client grâce à leur rentabilité et leur efficacité énergétique. Le marché mondial des tests diagnostiques à domicile, évalué à 12,73 milliards de USD en 2023, devrait atteindre 22,1 milliards de USD d'ici 2030, avec un taux de croissance annuel composé (CAGR) de 8,2%. Le processus d'examen 510(k) de la FDA prend généralement environ 90 jours pour être complété.
Ynvisible Interactive hat über 10.000 maßgeschneiderte E-Paper-Displays an ein führendes Diagnostikunternehmen geliefert, um sie in neuartige häusliche medizinische Diagnosetests zu integrieren, die derzeit von der FDA überprüft werden. Die Displays, die entwickelt wurden, um strengen Anforderungen der medizinischen Industrie gerecht zu werden, sollen dazu beitragen, den Marktanteil des Kunden aufgrund ihrer Kosten- und Energieeffizienz zu erhöhen. Der globale Markt für häusliche Diagnosetests, der im Jahr 2023 auf 12,73 Milliarden USD geschätzt wird, soll bis 2030 22,1 Milliarden USD erreichen, mit einer jährlichen Wachstumsrate (CAGR) von 8,2%. Der 510(k)-Überprüfungsprozess der FDA dauert in der Regel etwa 90 Tage.
- Successful delivery of 10,000+ customized e-paper displays for medical diagnostics
- Product under FDA review, indicating advancement in commercialization process
- Potential market expansion in USD 22.1B at-home diagnostics sector by 2030
- Cost-effective and energy-efficient technology advantages
- FDA approval still pending and uncertain
- Customer identity and product details undisclosed due to confidentiality agreements
- 90-day FDA review period could delay market entry
Vancouver, British Columbia--(Newsfile Corp. - October 24, 2024) - Ynvisible Interactive Inc. (TSXV: YNV) (FSE: 1XNA) (OTCQB: YNVYF) (the "Company" or "Ynvisible"), a leading provider of printed low-power e-paper display products, is pleased to announce that it has recently delivered more than 10,000 customized e-paper displays to a leading company in the diagnostics sector. This delivery comes as a critical step in the product commercialization process, as the displays were integrated into novel at-home medical diagnostic tests by Ynvisible's customer, and are currently under review by the Food and Drug Administration (FDA) in the United States.
Ynvisible had previously announced this collaboration with an emergent industry leader in medical devices, to develop the next generation of medical at-home testing and diagnostic solutions. The customized displays that Ynvisible developed for this application follow strict medical industry requirements. In addition, switching to Ynvisible's innovative display technology is expected to significantly increase market share over the coming years for this customer, due to the cost-effectiveness and energy efficiency of Ynvisible's e-paper displays, coupled with the advantages of roll-to-roll manufacturing.
Understanding the FDA Process
For devices like those using Ynvisible's displays, the FDA's 510(k) pathway is commonly followed. This process involves demonstrating that the device is equivalent to a legally marketed product. Preclinical tests, clinical studies, and a comprehensive review ensure the device meets FDA standards for safety and efficacy. Once submitted, the FDA generally takes around 90 days to complete the review. This step is crucial for bringing at-home medical devices like this to market.
Obtaining FDA approval for this specific diagnostics solution means that Ynvisible e-paper displays can become a standard solution for a wide range of medical and diagnostics products.
Market Growth in At-Home Diagnostics
The global market for at-home diagnostic testing is expanding rapidly. In 2023, the market was valued at USD 12.73 billion, with projections estimating it will grow to USD 22.1 billion by 2030, driven by a compound annual growth rate (CAGR) of
Several factors are driving this growth, including the increasing prevalence of chronic diseases, the demand for greater convenience, and technological advancements in diagnostic tools.
The ability to conduct medical tests at home has become a priority for many consumers, especially with advancements in diagnostics like glucose monitors and infectious disease tests. The COVID-19 pandemic further accelerated this trend, with demand for home testing rising significantly. Ynvisible's e-paper displays fit perfectly into this expanding market, offering low-power, easy-to-read solutions that support the growing need for accessible, at-home medical diagnostics.
With more than 10,000 units already delivered and the FDA review process underway, Ynvisible is well-positioned to reach a significant position in this market. Ynvisible will provide updates as this project progresses and looks forward to further opportunities within the healthcare sector.
Due to confidentiality agreements, Ynvisible cannot reveal the customer's name or disclose the specific design and functionalities of the product at this time. These agreements are crucial to protecting the customer's competitive advantage, reflecting the strategic value and significance of this collaboration.
About Ynvisible
Ynvisible is disrupting the low-cost and ultra-low-power display industry thanks to the latest advantages in sustainable electronics and roll-to-roll printing production. Ynvisible's printed e-paper displays are ideal for low-power and cost-sensitive applications, such as digital signage, smart monitoring labels for supply chain and logistics, visual indicators for medical and diagnostics, or retail labels and signage. Ynvisible has experience, know-how, and intellectual property in electrochromic materials, inks, and systems, and offers a mix of services, technology and products to brand owners developing smart objects and IoT products. Additional information on Ynvisible is available at www.ynvisible.com.
ON BEHALF OF THE BOARD OF DIRECTORS
Ramin Heydarpour
CEO and Executive Chairman
Ynvisible Interactive Inc.
For further information, please contact:
Investor Relations
+1 778-683-4324
ir@ynvisible.com
Public Relations
pr@ynvisible.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain statements that may be deemed "forward-looking" statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Ynvisible Interactive Inc. believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Ynvisible Interactive Inc. management on the date the statements are made. Except as required by law, Ynvisible Interactive Inc. undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
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FAQ
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