Simbex

Retired Dartmouth engineering professor Robert Dean, Simbex co-founder, was named a National Academy of Inventors fellow.

Coverage of Simbex's role in the Upper Valley tech ecosystem.

Presentation at the ASTM Sixth International Symposium on Safety in Ice Hockey, discussing the evolving value of Head Impact Monitoring in sports.

Regulatory and payment news relevant to medical device cybersecurity and exoskeleton reimbursement.

Monthly briefing on regulatory and healthcare reimbursement news relevant to Simbex areas of expertise.

Regulatory and payment news, including the impact of wearable technology data on health insurance policies.

Guidance on regulatory testing evidence required for US market clearance of medical devices.

Insights and lessons from Simbex's experience in medical device product development.

Overview of regulatory and reimbursement adaptations in response to the COVID-19 pandemic.

Reflections on health technology trends and products observed at CES, including innovations like BodyO’s AI POD for employee health monitoring and the potential for integration with personal health data platforms.

Regulatory and payment news, including FDA's proposed framework for AI-based medical devices.

Regulatory and payment news, including FDA's delay in QSR modernization and new reimbursement codes for pain management devices.

Summary of new European and US regulatory guidance on medical device cybersecurity, Brexit's impact on device regulation, FDA warnings on device cyber risks, and the growing investment in remote patient monitoring technologies.

Analysis of post-Brexit regulatory changes for medical devices, FDA guidance updates, and the evolving landscape for digital therapeutics reimbursement, including the economic impact of exoskeletons and new Medicare policies for prosthetics.

Overview of regulatory and payment news, including the FDA's Pre-Cert pilot for medical device software, changes in 510(k) clearance pathways, and trends in telehealth and hospital-acquired conditions.

Regulatory news including calls for better regulation of EHRs, updates to breast cancer screening, and CMS's AI Health Outcomes Challenge.

Regulatory and payment news on the delay of the EU Medical Devices Regulation and the expansion of telehealth during the COVID-19 pandemic.

Analysis of telehealth coverage, breakthrough device reimbursement, and modernization of payor policies in 2018.

Overview of regulatory trends including consumer tech partnerships, FDA process improvements, and upcoming changes for 2019.

Best practices and techniques for aligning expectations and delivering quality software in medical device development.

A virtual discussion on the dangers of assuming that insurance will pay for innovative Medtech devices, featuring Angela Smalley, Senior Commercialization Consultant at Simbex.

Simbex participated in the largest medical product design, development, and manufacturing event at the Anaheim Convention Center, discussing innovation and product development capabilities.