Maria Ida Iacono, PhD

- Prepared US regulatory strategies/plans to assure compliance while attaining business goals. Presented, explained, and defended strategic choices. - Authored two pre-submissions and led preparation of the team, meeting, and discussion with the FDA review team. Negotiated strategies on clinical trial, human factor validation study, and biocompatibility with FDA (in addition to other topics) which positioned Wandercraft in advantageous position while preparing for 510k submission. - Provided on-going scientific support to core and project teams for regulatory issues and questions. Found, interpreted, and applied US regulations and guidances. - Served as co-project manager for the improvement of the device and for the V&V activities needed for the submission of a 510k. - Authored a traditional 510k - the first at Wandercraft - that was cleared in <6 month (K221859). - Led Human Factors (HF) and Usability Engineering Process activities, including formative and summative evaluations, and related documentation according to FDA guidelines and applicable standards. - Developed strategy and finalized all clinical documentation for IRB approval of US clinical study on usability, including protocols, investigation brochures, non-significant risk determination, informed consents, case report forms, and all related documentation to be included in trial master file. - Managed and moderated US clinical study on usability at SRAL Ability Lab in Chicago

- Prepared Biomodex regulatory strategy as a general product for educational purposes and future medical device. - Discussed product’s claim and disclaimers with FDA which resulted in positioning Biomodex in a market niche as a general product while waiting for medical device transition. - Facilitated education of the R&D and commercial team on technical and regulatory aspects of the device. - Developed a procedure for the review, approval, and obsolescence of Promotional Marketing Literature for use within the United States. Ensured promotional material and advertising are consistent with regulations (e.g., adequate substantiation, consistency with approved labeling, balanced, not false or misleading). Monitored routinely external communication (press releases, web communications, social medial posts) and flagged information that can negatively impact the company in a timely manner. - Represented the company in regulatory agencies workshops (FDA BMES Frontiers on medical devices) or meetings and help delineate the regulatory landscape using targeted regulatory intelligence; - Represented the company in radiological or clinical society events and working groups (e.g., RSNA SIG working group) in order to facilitate and promote the adoption of the device.

- Served as a lead scientific reviewer for the CDRH Office of Device Evaluation (ODE). Completed +20 premarket scientific lead reviews, including pre-submissions, study risk determination Q-subs, 510(k)s, and medical devices development tools (MDDTs). - Served as subject matter expert in MRI RF safety of implantable passive and active medical devices and computational modeling for CDRH. Reviewed technical data and research protocols submitted in support of a variety of medical devices premarket submissions. Completed +40 premarket scientific review consults.

Leadership: - Principal Investigator on multiple research projects with external collaborators from industry, clinical, and academic groups. Initiate and propose statement of work, lead and coordinate with external collaborators the scientific effort, including acquisition of necessary technology, supervision of team involved in the collaboration, and scientific communication of activity in public meetings and peer-review journals. - Supervisor and mentor of contractors, students, and post-doctoral fellows. Initiate and establish national search for candidates, coordinate selection and hiring. Supervised 7 fellows since 2013. - Co-organizer and Lecturer of the First-Year Innovation & Research Experience (FIRE) program at University of Maryland (UMD) for students enrolling in the Deep Brain Neurotech Stream course. Research activity: - Implemented an MRI-based human head model (known as MIDA model) for analysis of safety and effectiveness of medical devices in, on, or near the head. The model’s high resolution (500-μm isotropic) and unprecedented number of structures resolved make it the most detailed anatomical head model reported to date worldwide. The model has been publicly released to the scientific community (https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm444659.htm) and is being used by >300 international research groups, including major medical devices manufacturers. - Computational modeling of invasive and non-invasive neurostimulation. - Computational modeling to investigate the MRI safety of patients with implantable passive (e.g., stents) and active (e.g., neurostimulators) medical devices.

Research activity: -Developed combined image registration and segmentation techniques to outline deep brain structures on low-resolution clinical MRIs -Generated an anatomical model of human basal ganglia from 7Tesla MRI data at 200 μm isotropic resolution for bioelectromagnetic analysis of DBS -Acquired and post-processed functional MRI (fMRI) data from experiments on monkeys using hyperoxia calibration -Investigated and compared normal and disordered brain using cortical thickness analysis

Visiting PhD student at MIT as part of MIT Rocca Program. Project: "3D anatomical deformation model of the basal ganglia for deep brain stimulation in Parkinson disease.”

Research activity: Designed, modified, and validated MR image processing algorithms for: -Image enhancement (e.g., contrast enhancement, noise removal, and artifacts reduction) -Rigid, affine, and non-rigid registration based on free-form deformations using voxel similarity measures -Image segmentation using semi-automatic algorithms, unsupervised clustering approaches, and atlas-driven strategies -Extraction of quantitative morphometric information (shape, volume, texture, thickness) -Data visualization, rendering, and navigation

-Experimental master thesis: developed an algorithm for the monitoring of high grade gliomas by non-rigid registration of serial follow-up MRIs -Served as Clinical Engineer

Image segmentation and registration

MRI, Image Processing, Computational Modeling

Bioengineering