Brian Bossetta

During the Medtech Conference in Toronto, a panel of industry leaders discussed the gaps that remain in women's healthcare and said innovation can help narrow them.

The US FDA has published a final guidance document providing stakeholders with a framework for various safety evaluations they should consider when developing medical products for newborns, including devices. The guidance focuses on long-term evaluations of neurodevelopmental safety.

Recognizing October as cybersecurity awareness month, the US FDA has added new publications to its list of resources concerning the cybersecurity of medical devices.

AdvaMed is calling on Medicare to provide coverage for supplemental screenings for women with dense breasts, an anatomical characteristic that puts them at a higher risk for cancer. The trade group says the lack of coverage for additional imaging results in many women not receiving potentially lifesaving follow-up.

In this week's Digital Health Roundup, Medtech Insight's Marion Webb talks about her interview with GE HealthCare's chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics' latest clinical results.

The US FDA's advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.

The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.

Despite the growing risks cybersecurity poses to the US healthcare system, the Department of Health and Human Services continues to face challenges in meeting the threat, according to a report from the GAO. The new report also provides recommendations for the department to beef up its cyber defenses.

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.

In its inaugural two-day meeting, the FDA Digital Health Advisory Committee discussed the promise of generative AI-enabled medical devices as well as challenges the agency faces in premarket evaluation, benefit/risk analysis, and postmarket monitoring.