#342: Planning an FDA Submission

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenA ...  Show more

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why ...  Show more

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology ...

<span style= "font-size: 12pt;"><span lang="EN" style= "mso-ansi-language: EN;" xml:lang="EN">Sarah Gallo</span> <span lang="EN" style="mso-ansi-language: EN;" xml:lang="EN">is ...

It’s worse than you think. Dr. Jane Ruby, a scientist with over 20 years of experience in regulatory processes for drug approval with the FDA, explains several important ways that the FDA and the drug companies violated the most basic safety protocols at every stage of the develo ...  Show more

<span style= "color: #333333; background: white;">Tracy Fink</span> <span style="color: #333333; background: white;">is the Director of Scientific Programs and Science and Poli ...