How might you summarise the #SMARTHEAL project?
By combining research across #Biomaterials, #SoftMaterials, #MedicalDevices, #SensorTechnology and #Surgery, #SMARTHEAL will deliver benefits for #science, #society and the #economy!
How might you summarise the #SMARTHEAL project?
By combining research across #Biomaterials, #SoftMaterials, #MedicalDevices, #SensorTechnology and #Surgery, #SMARTHEAL will deliver benefits for #science, #society and the #economy!
AI Powered Medical Devices Leads to Spike in Surgery Mistakes
Botched surgeries are on the rise after medical companies crammed AI into their medical devices to enhance surgery procedures.
https://www.freezenet.ca/ai-powered-medical-devices-leads-to-spike-in-surgery-mistakes/
#News #Technology #AI #FDA #medical #MedicalDevices #Medicine #Scary #Surgeon #Surgery
"Warren and Hawley’s 'Break Up Big Medicine Act' proposes prohibiting parent companies from owning a medical provider or management services organization and a PBM or insurer. It also proposes prohibiting parent companies of prescription drug or medical device wholesalers from owning a medical provider or management services organization."
https://thehill.com/policy/healthcare/5732189-break-up-big-medicine-act/
#healthcare #insurance #hospitals #clinics #PBM #PrescriptionDrugs #MedicalDevices #business #monopoly #UScongress
"Proponents predict the new technology will help find cures for rare diseases, discover new drugs, enhance surgeons’ skill and empower patients. But a Reuters review of safety and legal records, as well as interviews with doctors, nurses, scientists and regulators, documents some of the hazards of AI in medicine as device makers, tech giants and software developers race to roll it out.
At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022. The TruDi system isn’t the only one to come under question: The FDA has received reports involving dozens of other AI-enhanced devices, including a heart monitor said to have overlooked abnormal heartbeats and an ultrasound device that allegedly misidentified fetal body parts.
Researchers from Johns Hopkins, Georgetown and Yale universities recently found that 60 FDA-authorized medical devices using AI were linked to 182 product recalls, according to a research letter published in the JAMA Health Forum in August.
Their review showed that 43% of the recalls occurred less than a
year after the devices were greenlighted. That’s about twice the recall rate of all devices authorized under similar FDA rules, the review noted.
The AI boom poses a problem for the FDA, five current and former agency scientists told Reuters: The agency is struggling to keep pace with the flood of AI-enhanced medical devices seeking approval after losing key staff. A spokesperson for the U.S. Department of Health and Human Services, which includes the FDA, said it’s looking to boost its capacity in this area."

APR Co. accelerates its push into medical devices, targeting global anti-aging leadership with new EBD launches, while regulatory hurdles delay PDRN injectables; analysts see continued growth momentum amid strong R&D and global expansion plans.
Paralyzed man needs $100k exoskeleton to walk, mfg refused $20 battery repair & he couldn't walk
