MDG Boston: Software as a Medical Device (SaMD), Jan 8, 2020

Join CBSET at the MDG Boston forum, Software as a Medical Device (SaMD), Jan 8, 2020,  from 5:30-8:30 PM, at Regis College, Fine Arts Center, 235 Wellesley St, Weston, Massachusetts 02493.

Adaptive software-based technologies such as Artificial Intelligence (AI) and
Machine Learning (ML) have the potential to adapt and enhance medical device performance in real-time by deriving insights from the vast data collected to continuously improve healthcare delivery for patients.

Among the high-value applications identified by the FDA for such technologies are earlier disease detection, more accurate diagnosis, and development of personalized diagnostics and therapeutics. This forum will be a discussion on current trends in Software as a Medical Device (SaMD) including technological advances, regulatory challenges, and intellectual property strategies.


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Defining drug and target protein distributions after stent-based drug release: Durable versus deployable coatings. Tzafriri AR, Garcia-Polite F, Li X, Keating J, Balaguer JM, Zani B, Bailey L, Markham P, Kiorpes TC, Carlyle W, Edelman ER. Journal of Controlled Release. Volume 274, 28 March 2018, Pages 102-108

Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosisAbraham R. Tzafriri, Fernando Garcia-Polite, Brett Zani, James Stanley, Benny Muraj, Jennifer Knutson, Robert Kohler, Peter Markham, Alexander Nikanorov, Elazer R. Edelman. Journal of Controlled Release, Volume 264, 28 October 2017, Pages 203-210.

A tunable delivery platform to provide local chemotherapy for pancreatic ductal adenocarcinoma. Biomaterials: A tunable delivery platform to provide local chemotherapy for pancreatic ductal adenocarcinoma. Indolfi L, Ligorio M, Ting DT, Xega K, Tzafriri AR, Bersani F, Aceto N, Thapar V, Fuchs BC, Deshpande V, Baker AB, Ferrone CR, Haber DA, Langer R, Clark JW, Edelman ER. Biomaterials. 2016 Jul;93:71-82. doi: 10.1016/j.biomaterials.2016.03.044.