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Federal watchdog the General Accounting Office (GAO) will be investigating the FDA and its oversight of medical device recalls, highlighted by health crises related to Philips Respironics’ ventilators and CPAP devices. Read More
The FDA has classified three recalls as Class I because use of the devices carries the potential of serious adverse health effects and death. Read More
Delving into the development of AI in healthcare, Google researchers have penned an analysis of how AI has grown from a mere concept in the 1950s to be a dominant force in healthcare today, with leaders facing questions about its risks, problems and possibilities. Read More
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by University of California San Francisco (UCSF) researchers. Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid out the final roadmap for 2024 to create a comprehensive set of regulations for medical devices and technology, bringing the UK one step closer to finalizing its regulatory framework after leaving the EU. Read More
FDA Commissioner Robert Califf wants to push the agency toward approving AI assisted medical devices that contain algorithms capable of learning, adapting and changing as they gather and analyze more data — which is not the technology in the AI-assisted devices FDA has approved thus far. Read More
This edition of Quick Notes looks at recent FDA Class I and company recalls involving patient return electrodes, pump-incompatible syringes, unintentional double drug dosing and missing zeroes. Read More