New wearable device system could aid in remote medical monitoring
Editor's Note A new wearable monitoring device system from researchers at the University of Arizona aims to make digital health access more equitable. These research findings were published in the Proceedings of the National Academy of Sciences on December 4. The new device can reportedly send health data up to…
Researchers develop new early stage breast cancer detection device
Editor's Note Researchers from the University of Waterloo have devised a new, noninvasive method for detecting early stage breast cancer in just 2 minutes using very low electro-magnetic frequencies. The findings were first published in August in the Nature journal Scientific Reports. The research team discovered that very low electro-magnetic…
New MRI scanner is reportedly 10 times more powerful than regular machines
Editor's Note An international team of researchers has unveiled a new magnetic resonance imaging (MRI) scanner that is reportedly significantly more powerful than conventional MRI machines, a November 27 article published by Nature Methods reports. The new MRI is said to record up to 10 times with more detail than…
FDA encourages new cybersecurity standards on medical device manufacturing
Editor's Note The US Food and Drug Administration (FDA) has recognized the latest guidance on medical device cybersecurity from the Association for the Advancement of Medical Instrumentation (AAMI), an AAMI November 14 press release reports. This latest cybersecurity recognition is encouraging its use across the medical device manufacturing industry to…
New water quality standard released by AAMI
Water is a major component of medical device processing. It is used in cleaning solutions, rinse water, and to generate steam for sterilization. Because of its crucial role in medical device processing, the Association for the Advancement of Medical Instrumentation (AAMI) determined it was necessary to upgrade the Technical Information…
Researchers identify immunity-driven factors behind rejection of medical implants
Editor's Note Medical devices such as pacemakers, breast implants, or knee replacements often cause hostile immune responses that can damage not only the implants but also surrounding tissue in the patient. That rejection often leads to further intervention needed that may include medications such as immunosuppressants or additional procedures. Researchers…
AAMI: Time, temperature, humidity affecting cleanliness of instruments, medical devices
Editor's Note Researchers for a long time have expressed concern about how time and temperature might contribute to changes that affect the cleaning and sterilization of instruments. However, there have been few studies examining these claims. A September 2023 study in Biomedical Instrumentation and Technology from the Association for the…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
CISA: New 'high-risk' cyber vulnerability for Medtronic cardiac device management system
Editor's Note On June 29, the Cybersecurity & Infrastructure Security Agency (CISA) issued a medical advisory alert "warning of a significant, high-risk vulnerability in Medtronic’s Paceart Optima System, which is used to compile and manage patients’ cardiac device data," the American Hospital Association (AHA) July 6 reports. According to CISA,…
Endoscope manufacturer Olympus Medical receives third warning from FDA
Editor's Note The FDA on March 15 issued its third warning letter to endoscope manufacturer Olympus Medical, following a manufacturing site inspection and 160 complaints of device failure, as reported by Beckers. The warning letter comes after a Tokyo, Japan facility inspection, where the Single-Use Distal Covers for Duodenoscopes and…
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