MCRA Expands Digital Health Division

MCRA Expands Digital Health Division

WASHINGTON, May 18, 2021 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce Alex Cadotte, PhD, Former U.S. Food and Drug Administration (FDA) Team Lead for Imaging Software, has joined MCRA. Dr. Cadotte is a published author, award recipient, and central figure in the regulation of digital health and imaging devices at FDA with 15 years of engineering, clinical, and regulatory experience. He was also a member of the CDRH Artificial Intelligence/Machine Learning (AI/ML) Working Group where he was a contributor to the recent AI/ML Action Plan and Predetermined Change Control Plan development.    

Dr. Cadotte joined MCRA, LLC as Associate Director of Software and Digital Health. Prior to joining MCRA, Dr. Cadotte served in multiple key roles in the digital health arena at FDA, including Division Lead, Software and Digital Health, and Senior Lead Reviewer in the Mammography, Ultrasound and Imaging Software Branch.  In addition to Dr. Cadotte’s vast experience in digital health, he also brings valuable expertise in artificial intelligence and machine learning, Computer Aided Detection / Diagnosis / Triage, Quantitative Imaging, the pre-certification program, Real World Performance, Good Machine Learning Practices, software lifecycle processes, cybersecurity, and mobile medical applications.

He has extensive knowledge of FDA’s Total Product Life Cycle, having provided oversight of 510(k), De Novo, Pre-Submission and Pre-Market Authorization (PMA) submissions. His post-market authorization experience includes response and drafting of warning letters and inspection reports.

MCRA’s Director, Digital Health Regulatory Affairs, Nikki Batista, said, “Digital Health is a rapidly growing and complex area of innovation, and navigating the pathway to market requires intentional, efficient, and sound strategic thinking and tactical implementation. The MCRA Digital Health team is committed to providing clients with first-class service, and we are thrilled that Alex has joined our team and will play an instrumental role in supporting clients developing industry shifting technology.”

Dr. Cadotte said, “It’s an amazing time to be working in digital health. FDA’s Digital Health Center of Excellence is focused on new and least burdensome means of regulating digital health technology. Understanding how your devices fit into this shifting paradigm can be critical for product development and regulatory success.  I’m honored to work with all of MCRA’s service divisions to streamline medical device development from a total product lifecycle perspective.”

About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity.

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. 

For more information, please contact:

Alyssa Howard
Senior Director, Business Development
Phone: 215.870.3952
Email: [email protected] 


Adblock test

Published at Tue, 18 May 2021 10:52:30 +0000

Insights on the BFSI Security Global Market to 2027 – Opportunity Analysis and Industry Forecasts …

DUBLIN–()–The “BFSI Security Market by Security Type, Enterprise Size, and End User : Global Opportunity Analysis and Industry Forecast, 2020-2027” report has been added to’s offering.

BFSI security involves a set of technologies such as artificial intelligence, cloud computing, machine learning, and big data. In addition, the BFSI sector consists of a group of companies that are dealing in core financing products & services. Furthermore, BFSI security solution & services help to prevent unauthorized access by hackers, safeguard networks, and reduce risk of potential malware.

Rise in adoption of advance technologies such as cloud computing, application programming interfaces (APIs), data analytics, artificial intelligence, robotic process automation (RPA), chatbots, and machine learning, which improves quality of financial data across various regimes boosts the BFSI Security Market growth. In addition, surge in physical & cyber threats among the BFSI sector also propels the BFSI Security Market growth. However, concerns over consumer data privacy, risk of third-party security services, and huge cost of software implementation are some of the factors that hamper the market growth.

On the contrary, several regulatory bodies are promoting & investing in security solutions & services in the BFSI sector for their business processes to expand. In addition, rapid expansion of banks, insurance companies, financial institutions, and other financing firms across developing countries is expected to increase demand for implementation of security solutions. These factors, as a result anticipated to boost the BFSI Security Market share in the coming years.

The BFSI security market size is segmented on the basis of security type, enterprise size, end user, and region. On the basis of security type, the market is bifurcated into physical security and information security. In terms of physical security, the BFSI security market is further bifurcated into system and services. Based on information security, the BFSI security industry is further bifurcated into solution and services. On the basis of enterprise size, it is segmented into large enterprises and small & medium enterprises (SMEs). By end user, it is segmented into banks, insurance companies, and others. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

BFSI Security Market Key Players

The report analyses profiles of key players operating in the BFSI security market, which include Booz Allen Hamilton Inc., Broadcom, Cisco Systems, Inc., Dell Inc., Honeywell International Inc., IBM Corporation, McAfee, LLC, Microsoft, Sophos Ltd, and Trend Micro Incorporated. These players have adopted various strategies to increase their market penetration and strengthen their position in the industry.

Key Benefits

  • The study provides in-depth analysis of the global BFSI security market along with the current & future trends to illustrate the imminent investment pockets.
  • Information about key drivers, restrains, & opportunities and their impact analysis on the market size are provided in the report.
  • Porter’s five forces analysis illustrates the potency of buyers and suppliers operating in the industry.
  • The quantitative analysis of the global BFSI security market from 2020 to 2027 is provided to determine the market potential.

Market Dynamics


  • Surge in adoption of digitalization in BFSI sector
  • Increasing physical & virtual threat in the BFSI sector


  • Risk of third-party services
  • Huge cost for an implementation of technological securities in the BFSI sector


  • Rise in adoption of internet in the BFSI sector

Key Players

  • Booz Allen Hamilton Inc.
  • Broadcom
  • Cisco Systems, Inc.
  • Dell Inc.
  • Honeywell International Inc.
  • IBM Corporation
  • McAfee, LLC
  • Microsoft
  • Sophos Ltd
  • Trend Micro Incorporated

For more information about this report visit

Adblock test

Published at Tue, 18 May 2021 10:30:00 +0000