FDA Seeks $60 Million in Funding to Improve Access to Safe and Effective Medical Products
The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
Tag Archives: machine learning
Disruptive Digital Health Models: Improving Access, Eliminating Bias and Delivering Higher Quality Care
Fueled by the need to provide quality care during a global pandemic, healthcare stakeholders are acting quickly to identify new opportunities and overcome challenges.
Artificial Intelligence Boosts New Era of Postmarket Intelligence
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.
Potential for Artificial Intelligence in the Prevention and Detection of Cardiac Arrest
AI’s arrival in the cardiovascular profession brings a plethora of new opportunities for providing innovative, tailored treatment.
The Power of Artificial Intelligence in the Medical Field
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.
Biopharma and Medical Device Trends Investors Should Watch in 2022
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.
AI/ML-based SaMD: Trends in Litigation
This pioneering area of technology comes with new risks and questions of liability.
Developing Robust AI Medical Products Requires Facing Data-Driven Truth
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.
The Regulatory Aspects of AI/ML-based SaMD
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 Prevalence of Neurological Disorders Pushes Scope of Wearable Medical Devices
The increasing incidence of hearing loss and neurological diseases has prompted the development of convenient and enhanced solutions in wearable healthcare devices.
