Digital Health

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

In addition to its recently established Precision Health division, Bayer Consumer Health is using artificial intelligence to save time on routine tasks and to manage supply and demand, the firm’s head of digital transformation and IT, Cristina Nitulescu, tells HBW Insight.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.

Altoida CEO Mark Jones has high hopes that the company’s digital assessment tool will be approved by the FDA to be used along with blood biomarker testing by primary care doctors to help predict Alzheimer’s disease before patients show symptoms.

Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

In recent conference presentations, the US FDA commissioner has highlighted a NASA project to standardize cockpit layouts as a model that the device center’s home health initiative may follow.