ARTICLES BY BOB MARSHALL
Challenges To FDA’s Modernization Of The 510(k) Pathway
The FDA and CDRH need to take a hard look at their plan to revamp the 510(k) pathway -- as well as how that regulatory path has been handled to date. Continue Reading..
Cruising Down The Avenu Until They Turned Onto De Novo Way…
To De Novo, or not to De Novo, that is the question: whether ‘tis nobler in the mind to suffer the slings and arrows of outrageous regulations, or to take arms against them. Continue Reading..
Helping Burn Victims Feel Comfortable In Their Own Skin
The American Burn Association reported approximately 486,000 fire or burn injuries were seen at emergency departments between 2011 and 2015. AVITA Medical has developed their ReCell skin regeneration platform (currently under FDA PMA review) to improve outcomes for burn victims. Continue Reading..
Arrhythmia Is Gonna Get You
Existing electrophysiology systems don’t have the fidelity, or noise floors in the hardware and software, to allow doctors to see subtle abnormalities. Doctors believe the ability to see these subtle abnormalities may enable them to provide better, more accurate treatment for arrhythmia. Continue Reading..
De Novo Working As Intended: A Case Study
He sat there in the room, looked the FDA reviewers in the eye, and told them there were 10 people who died at his site during the trial, and if he had been allowed to use the data from the new diagnostic, he could have saved at least five of them. Continue Reading..
Pioneers Recall The “Good Old Days” Of Device Development
I love “old school” hardware stores. My best Saturdays, when I’m not out fishing in my little boat, are spent with a pencil behind my ear and a home improvement project to conquer. Continue Reading..