Healthcare AI Market Explodes 38.5% Annually as Diagnostics Gain FDA Traction

Cision Canada

a day ago

VANCOUVER, BC, Aug. 12, 2025 /CNW/ -- USA News Group News Commentary – Research and development of new AI-powered tech is causing a major overhaul in the healthcare sector, with experts both optimistic and horrified at the same time. Analysts at market.us are forecasting the global AI in healthcare market to hit nearly $700 billion by 2034, growing at an explosive 38.5% CAGR along the way. With new technologies getting closer to full FDA approval, now one of the biggest hurdles for AI in healthcare is gaining the trust of clinicians and patients alike, all while proving efficacy of these new solutions. From an investment standpoint, the opportunity is enormous, with the market paying closer attention to AI roll outs and the developers behind them, including Avant Technologies, Inc. (OTCQB: AVAI), RadNet, Inc. (NASDAQ: RDNT), Clover Health Investments, Corp. (NASDAQ: CLOV), Tevogen Bio Holdings Inc. (NASDAQ: TVGN), and Butterfly Network, Inc. (NYSE: BFLY).
Accenture projects AI could unlock $461 billion in healthcare value by 2035, but success requires platforms that deliver reliable results in critical diagnostics where mistakes prove dangerous. Several innovators are developing advanced systems to capture this opportunity across patient screening and drug discovery.
Avant Technologies, Inc. (OTCQB: AVAI) and joint-venture partner Ainnova Tech have accelerated their FDA approval timeline for Vision AI, an AI-powered diagnostic tool that can detect diabetic retinopathy in minutes without requiring an eye specialist on-site. The companies have accelerated their timeline by finalizing an enhanced patient recruitment strategy targeting approximately 1,000 multiethnic patients across 8-10 U.S. clinical sites. Ainnova will collaborate directly with Fortrea, a globally recognized contract research organization specializing in ophthalmology studies, to recruit patients primarily from community clinics and primary care facilities. This approach captures real-world data that reflects the diverse population affected by diabetic retinopathy while positioning Vision AI for broader commercial adoption.
"By focusing on community clinics and targeting a multiethnic group of around 1,000 diabetic patients, we aim to ensure that our study accurately represents the diverse population affected by diabetic retinopathy," said Vinicio Vargas, CEO at Ainnova and Board member of Ai-nova Acquisition Corp. (AAC). "Working with Fortrea, an expert CRO in ophthalmology, allows us to confidently navigate this process with a partner that shares our commitment to quality and efficiency. We are getting closer to initiating a clinical study that will significantly contribute to obtaining FDA 510(k) approval and making our Vision AI platform a crucial tool in early disease detection."
This recruitment breakthrough builds on decisive regulatory progress following Ainnova's mid-July pre-submission meeting with the FDA, where the agency delivered clear guidance on study design and compliance requirements. The refined clinical trial protocol, which addresses all FDA comments, has been presented to Fortrea for final review and will set the stage for a formal U.S. study that supports FDA 510(k) clearance to market Vision AI domestically.
Beyond regulatory advancement, Vision AI is gaining commercial momentum across multiple fronts. Vargas recently showcased the platform at Roche's"Macular Spectacular" conference in Colombia, highlighting breakthrough results from a Q4 2024 pilot with Roche and Salud 360 that positions Vision AI for expansion across the U.S., Canada, and Europe.
The technology has already gone live through Grupo Dökka's Fischel and La Bomba pharmacy chains, delivering walk-in screenings with real-time AI results and eliminating the need for onsite ophthalmologists.
This proven pharmacy model is attracting attention from insurers and life sciences partners who recognize Vision AI's potential to transform preventive care delivery. The platform's cost-effective approach addresses critical gaps in diabetic eye care while creating new revenue streams for retail healthcare providers.
Vision AI's success positions Ainnova to dominate broader disease detection markets. The company's expanding roadmap includes cloud-connected retinal cameras for rural clinics and revolutionary modules targeting Alzheimer's, cardiovascular conditions, and other chronic diseases through advanced retinal and blood biomarker analysis.
With diabetic retinopathy affecting 9.6 million Americans and representing a US$3.25 billion U.S. market projected to nearly double to US$6.1 billion by 2033, Avant maintains worldwide licensing rights to Ainnova's platform through AAC. This positions U.S. market entry as a transformative commercial inflection point.
Avant continues evaluating a strategic acquisition of Ainnova Tech under a previously announced non-binding LOI, potentially consolidating breakthrough AI healthcare technologies and proven leadership under a single public platform. The company has also signaled plans for a dedicated therapeutic-focused spinout, creating multiple pathways to capture the expanding AI-driven healthcare transformation.
RadNet, Inc. (NASDAQ: RDNT), through its wholly-owned subsidiary DeepHealth Inc., received FDA 510(k) clearance for TechLive™, a remote scanning solution that enables centralized operation of MR, CT, PET/CT, and ultrasound procedures across multiple locations simultaneously. The technology addresses critical radiology technologist shortages by allowing expert staff to remotely guide complex procedures, with pilot deployments showing a 42% decrease in MRI room closure hours.
"TechLive™ represents a paradigm shift in how we approach imaging operations," said Sham Sokka, PhD, Chief Operating and Technology Officer at DeepHealth. "By enabling real-time remote expertise, we are not only addressing today's staffing challenges, we are creating a foundation for more efficient, financially sustainable, and high-quality patient care across the broadest set of imaging modalities. This FDA clearance validates DeepHealth's vision of a connected imaging ecosystem that scales human expertise beyond physical boundaries."
RadNet has already connected over 300 imaging systems with TechLive™, positioning the company to expand operational efficiency while improving patient access to advanced diagnostic procedures.
Clover Health Investments, Corp. (NASDAQ: CLOV), through its wholly-owned subsidiary Counterpart Health, released clinical data showing its AI-powered Counterpart Assistant technology correlates with significantly improved COPD patient outcomes, including 15% fewer hospitalizations and 18% lower 30-day readmissions.
"This whitepaper shows how translating raw data into real-time clinical insight can transform care," said Conrad Wai, CEO of Counterpart Health. "By equipping physicians with timely, meaningful guidance, Counterpart Assistant helps deliver better outcomes for patients and reduce costs."
The platform synthesizes over 100 real-time data streams to provide actionable recommendations within clinical workflows, with COPD patients under Counterpart-enabled primary care physicians showing 75% higher diagnosis rates and 18% more specialty care visits. This marks Counterpart's fifth published study demonstrating clinical impact across chronic diseases including diabetes, heart failure, and kidney disease management.
Tevogen Bio Holdings Inc. (NASDAQ: TVGN) has evolved from a biotechnology company into a dual-platform enterprise expanding into artificial intelligence through Tevogen.AI while maintaining 74% insider ownership. The company successfully launched its AI-driven PredicTcell™ platform with strategic partnerships including Microsoft and Databricks, significantly enhancing drug target discovery efficiency with potential savings of billions in development costs.
CEO Ryan Saadi affirmed the company's strong capital position and growth trajectory, highlighting progress from clinical validation of its ExacTcell™ platform to establishing manufacturing capabilities and robust intellectual property portfolios.
"Tevogen has become a recognized name for its business philosophy of social responsibility, patient affordability and cost efficiency," wrote Saadi in a CEO letter. "In under five years, we validated our proprietary ExacTcell™ platform, completed successful proof-of-concept clinical trial of the platforms first product, established drug discovery R&D center — currently in the process of establishing our own GMP cell manufacturing facility, expanded corporate infrastructure, built a robust intellectual property portfolio, and established one of the pioneering AI initiatives in the industry — assets of significant value, while maintaining 74% insider equity ownership."
Butterfly Network, Inc. (NYSE: BFLY) advanced AI-powered cardiac screening through new research demonstrating machine learning models can achieve 94% accuracy in detecting aortic stenosis using handheld ultrasound devices.
"This research shows a promising path forward where lower-level providers, not just cardiologists or trained sonographers, could screen for aortic stenosis using AI-assisted handheld ultrasound," said Dr. John Martin, co-author of the study and Butterfly's Chief Medical Officer Emeritus. "This opens the door to early detection in a wide variety of care venues including primary care offices, long term care facilities, urgent care facilities and even in the home."
The study, published in European Heart Journal, validates the potential for lower-level providers to screen for this life-threatening condition that affects over 13% of Americans over 75 and often goes undiagnosed until advanced stages. Butterfly also released new Aorta Exam training protocols on its ScanLab™ platform, combining AI-assisted diagnostics with educational tools to democratize access to critical cardiovascular screening capabilities.
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