PreciseDX

How AI Can Advance Breast Cancer Detection and Treatment

By Ted M. Diehl, Wayne Brinster
PreciseDX

The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.

Continue reading

510k Submission Planning

510k Submission Planning

By Joy Greidanus
510k Submission Planning

510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.

Continue reading

Regulations

Regulatory Advocacy: Amplifying Your Voice

By MedTech Intelligence Staff
Regulations

Companies have several avenues available to share their input on and help shape MedTech regulation. At the 2023 MedTech Regulatory Intelligence Summit, former FDA CDRH member Steven Silverman, and Patterson Shafer, strategic advisor to FDA, offered guidance on how to establish credibility with FDA and the most effective ways to make your voice heard.

Continue reading

Dhirti Roy

Ask the Expert: Benefits and Challenges of the eStar Submission Process

Dhirti Roy

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

Continue reading