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.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
During the COVID-19 crisis, digital forces like artificial intelligence have assisted the healthcare industry to focus on patient care while achieving improved efficiency during treatments.
GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy.
A return to normalcy requires us to address the limits of current testing approaches and broadly deploy reliable screening tools that facilitate early detection and encourage more focused testing of those at high-risk of spreading the coronavirus.
No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.