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Is it time for an AI regulatory framework?

By Michael Joe Cini

MedTech World is a global summit that brings together leading companies, startups, investors, healthcare professionals, and the media to share health-tech ideas. It offers a platform where healthcare professionals can explore and help shape products that will impact the future of medicine. One of our panel sessions at the November 2022 Malta Week was themed: … Continued

AI CREATES HEADACHES FOR MEDICAL DEVICE MAKERS

By Michael Joe Cini

Medical devices based on artificial intelligence (AI) present a unique set of challenges for regulators, with no comprehensive standards in place to address the issue.  It’s an issue that the International Medical Device Regulators Forum (IMDRF) has recognised. Currently, the regulatory requirements in the European Union (EU) and other major medical markets do not address … Continued

FDA issues alert on Medtronic insulin pump security

By Michael Joe Cini

Medtronic issued an urgent warning to alert consumers to this risk and offer advice. The U.S. Food and Drug Administration issued a warning on Tuesday regarding the vulnerability of some insulin pump devices made by Medtronic (MDT.N) to cyberattacks and the possibility that hackers could interfere with insulin delivery by gaining access to the device. … Continued

FDA pushes for ethnic diversity in clinical trials

By Michael Joe Cini

A new draft guidance from the FDA recommends sponsors develop and submit a Race and Ethnicity Diversity Plan Researches and clinical trials are the backbones of medicine – and if medicine is for all, then the topic of discussion is pertinent. Long-established social and economic inequalities increase the health risks and vulnerabilities for Blacks, Indigenous, … Continued

FDA proposes over-the-counter hearing aids

By Michael Joe Cini

The Food and Drug Administration believes barrier-free hearing aids could increase accessibility and boost the economy The FDA has proposed the creation of a whole new category of hearing aids that can be purchased without providing a medical exam or having them fitted by an audiologist. Over-the-counter hearing aids seek to be an affordable barrier-free … Continued

AMA ethics journal questions FDA medical device laws & safety checks

By Michael Joe Cini

The AMA Journal of Ethics has taken an analytical view of the US medical device regulation, raising doubts on the FDA’s balance between innovation promotion and patient protection Ariel Wampler of Lahey Hospital in Massachusetts, an expert on cosmetic and reconstructive operations, provided statistics on regulation, usage, and effects of medical devices. Although most statistics … Continued