The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
Fueled by the need to provide quality care during a global pandemic, healthcare stakeholders are acting quickly to identify new opportunities and overcome challenges.
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
AI’s arrival in the cardiovascular profession brings a plethora of new opportunities for providing innovative, tailored treatment.
Opportunities for intelligent computer systems span widely, including extensive use in medical science. Artificial intelligence enhances cognition analysis of complex health issues and improves the diagnoses. However, there are still some challenges in terms of data quality, regulations, market penetration and adaptation.
For private equity and venture capital investors alike, there are five key trends presenting both headwinds and tailwinds that may impact investment flows into 2022.
This pioneering area of technology comes with new risks and questions of liability.
As more medtech companies take advantage of the game-changing technology to innovate and advance products, they must anticipate the need to obtain trustworthy, evidence-based comprehensive data—and be prepared to do their own due diligence to verify the chain of evidence and meet increasingly stringent regulatory requirements.
Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
The increasing incidence of hearing loss and neurological diseases has prompted the development of convenient and enhanced solutions in wearable healthcare devices.