Issued on behalf of Avant Technologies Inc.
VANCOUVER – Baystreet.ca News Commentary – Within the modern western healthcare sector, artificial intelligence (AI) is being enlisted to streamline authorizations, and reduce bureaucratic complexities. The hope is that AI won’t actually replace doctors (despite Bill Gates’ claims), but truly upgrade them. Healthcare is clearly evolving, through the intelligent use of AI in the sector, and with recent developments from Avant Technologies, Inc. (OTCQB: AVAI), SOPHiA GENETICS (NASDAQ: SOPH), AstraZeneca (NASDAQ: AZN), Microsoft Corporation (NASDAQ: MSFT), and Doximity, Inc. (NYSE: DOCS).
The article continued: Barclays projects the AI healthcare market will grow at an impressive compound annual rate (CAGR) of 30% through 2030, fueled by accelerating investment from pharmaceutical firms, hospitals, and insurers. According to a recent Deloitte report, 71% of healthcare leaders expect profitability to improve this year, thanks in part to growing AI adoption across care systems.
Avant Technologies and Ainnova Request Pre-Submission Meeting with US FDA for VisionAI Platform Technology
Avant Technologies, Inc. (OTCQB: AVAI), an emerging leader in AI-driven healthcare innovation, and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that The Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA) has received the company’s submission package requesting a pre-submission meeting with the FDA for its VisionAI platform technology and is now under review.
Ainnova is requesting a pre-submission meeting with the FDA’s review team to discuss any questions and/or concerns about its proposed formal submission, including seeking advice to finalize the protocol and obtain agency guidance for a clinical trial of its VisionAI platform in the early detection of diabetic retinopathy. A pre-submission meeting allows companies to clarify regulatory requirements, get feedback on their plans, and potentially avoid delays or issues during the formal review process.
The clinical studies will aim to support an FDA 510(k) submission to obtain clearance from the regulatory agency to market its technology in the U.S.
Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova’s technology portfolio, including its VisionAI platform and its versatile retinal cameras, has worldwide licensing rights for this portfolio. The licensing rights include the U.S., where the FDA regulates drug and medical device development, so the success of Ainnova’s interactions with the FDA are paramount to marketing the technology portfolio in the United States.
“This milestone reflects our two-tiered strategy, rapid deployment in low-regulation markets where VisionAI operates as a screening tool, and simultaneous progress toward FDA clearance for the U.S. market,” said Vinicio Vargas, CEO at Ainnova and a member of AAC’s Board of Directors. “Entering the U.S. will unlock significant commercial potential, and early engagement with regulators ensures we do so with speed, credibility, and a validated product.”
For medical device applicants like Ainnova, the FDA’s pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the
number of patients and the number of clinics that will be needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova’s VisionAI platform.
For Avant, the pre-submission meeting will help define a precise budget for the strategic partnership’s entire FDA process.
This follows Ainnova’s recent strategic alignment with Apollo Hospitals in Southeast Asia, where the Vision AI platform has been cleared for commercial deployment in Brazil, and clinical pilots are being prepared across the Americas. Avant and Ainnova have identified Brazil and the United States as key strategic markets. Ainnova is currently addressing regulatory pathways in Brazil with the support of its MDSAP certification to meet ANVISA requirements, paving the way for rapid market entry.
Ainnova is being guided by global CRO Fortrea ahead of the important pre-submission meeting with the FDA. The goal is to seek 510(k) clearance for Vision AI in detecting diabetic retinopathy, a gateway to broader use across multiple chronic disease categories.
Between FDA progress, high-profile alliances, and a growing international presence, Avant Technologies continues to carve out a niche in the convergence of AI, diagnostics, and preventative care. Investors looking for small-cap exposure to the healthcare AI revolution may want to keep AVAI on the radar as these developments unfold.
CONTINUED… Read this and more news for Avant Technologies Inc. https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
SOPHiA GENETICS (NASDAQ: SOPH) recently expanded its collaboration with AstraZeneca (NASDAQ: AZN) to deploy its liquid biopsy solution, MSK-ACCESS® powered with SOPHiA DDM™, to 30 sites globally in 2025.
“Our collaboration with AstraZeneca represents a significant step toward scaling next-generation oncology diagnostics globally,” said Ross Muken, President, SOPHiA GENETICS. “This expanded deployment reflects the growing momentum behind liquid biopsy and our shared ambition to make these technologies more accessible and impactful worldwide.”
The test uses blood samples to detect cancer-linked genetic changes, offering an easier alternative when tissue biopsies aren’t feasible. Real-world data shows the test maintains high accuracy and reliability across different labs. This move supports AstraZeneca’s broader strategy to build real-world evidence for next-generation cancer diagnostics.
Microsoft Corporation (NASDAQ: MSFT) recently expanded its Azure Marketplace offerings by adding Ambience Healthcare’s AI platform for clinical documentation and coding.
“Microsoft welcomes Ambience’s AI platform for health systems to Azure Marketplace, where global customers can find, try, and buy from among thousands of partner solutions,” said Jake Zborowski, General Manager, Microsoft Azure Platform at Microsoft Corp. “Azure Marketplace and trusted partners like Ambience Healthcare help customers do more with less by increasing efficiency, buying confidently, and spending smarter.”
Built to integrate seamlessly into Azure’s cloud infrastructure, Ambience helps hospitals reduce clinician note-taking time and improve billing accuracy across more than 100 specialties. The addition supports Microsoft’s broader healthcare strategy by giving providers faster access to secure, AI-powered workflow tools.
Earlier this year, Doximity, Inc. (NYSE: DOCS) was named Best in KLAS for telehealth video platforms for the fourth consecutive year, with its Doximity Dialer earning top scores in every performance category.
“We’re honored to help physicians deliver high-quality care anytime, anywhere,” said Jeff Tangney, co-founder and CEO of Doximity. “We’re grateful for this recognition and the opportunity to support better, more connected patient care.”
The company’s HIPAA-compliant platform allows clinicians to seamlessly switch between phone, video, and text visits while protecting patient privacy. Surveyed health system leaders rated Doximity highly for product quality, operations, culture, and value. This ongoing recognition highlights Doximity’s role as a trusted leader in digital healthcare solutions.
Source: https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
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