The multicenter international study, which enrolled 258 patients across 15 sites in the U.S. and Japan, compared HeartFlow’s automated deep-learning-based method for segmenting coronary atherosclerosis in coronary computed tomography angiography against the reference standard of intravascular ultrasound.
Information Sharing and Analysis Centers (ISACs), developed to help critical infrastructure industries prevent and become more resilient to cyber and physical security attacks, are expanding their strategies to meet ever-evolving threats. Errol Weiss, Chief Security Officer of the Health-ISAC, discusses how these groups work to protect industry, emerging threats and how device developers and healthcare organizations are working together to protect patients.
The new equity guide provides implementation steps to help developers and users implement the AHRQ Digital Healthcare Equity Framework to ensure new technologies ameliorate, rather than exacerbate, inequities in health care.
Although 61% of decision-makers at healthcare organizations said their firms invested at least $100 million in digital transformation initiatives over the past year, 65% of those respondents said their firms have translated less than half of those investments into tangible business value. These numbers highlight the challenges of digital transformation with data siloes posing the biggest threat to success.
Researchers have developed a new machine-learning model that can precisely make prognosis predictions for patients with osteosarcoma, based on the density of viable tumor cells post-treatment.
“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.
Mayo Clinic News Network/ — In a review published in Cancers, the researchers note that this emerging class of AI offers an innovative way to use massive datasets to help discover the complex causes of diseases such as cancer and improve treatment strategies.
While the MedTech industry continues to face significant challenges related to regulatory requirements, cybersecurity issues, recalls and lawsuits, leaders in the industry are navigating and overcoming these areas to push innovation forward like never before.
The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”
Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.
