Latest Clearance Success for Intuitive Powered by NEST Mark
05 Agosto 2024 - 2:35PM
Business Wire
The NEST Mark initiative which is being developed by the
National Evaluation System for health Technology (NEST) has
succeeded in empowering yet another efficient and streamlined path
to FDA clearance for Intuitive labeling modification for its
previously cleared robotic-assisted surgical devices (RASD) da
Vinci Xi and X Surgical Systems.
Recognizing the immense potential of real-world evidence (RWE),
Intuitive sought to identify and leverage fit-for-purpose data
through the NEST Mark process in their pursuit of the labeling
modification. This achievement is the latest success story powered
by NEST Mark, a collaborative program focused on partnering with
industry to maximize the impact of the use of RWE in the premarket
stage of product development.
“Working with the National Evaluation System for health
Technology helped us find and synthesize real-world data into
real-world evidence that could support our labeling revision,” said
Jaime Wong, Intuitive’s senior vice president and senior medical
officer. “The NEST Mark process demonstrated for us the utility of
this type of collaboration, which is a significant advancement in
regulatory science,” said Wong.
RESULTS THAT ARE FIT-FOR-PURPOSE
The NEST Mark process is being created by NEST to help catalyze
the use of real-world data and evidence to support the development
and use of new medical technologies. In collaboration with all NEST
stakeholders, the NEST team guides the design and execution of
studies to deliver results that are fit-for-purpose and aligned to
the highest standards of RWE application.
Working across an extensively verified network of research
partners and commercial services partners, NEST Mark facilitates
efficiency through the assessment of data sources and the
identification of best-positioned collaborators to pursue RWE based
submissions. The NEST Mark process allows a company to perform a
quick evaluation of the likelihood of success with the real-world
data (RWD) and proceed to a study with greater confidence.
“We are excited to have served as a force multiplier for
Intuitive Surgical on their journey to clearance on this label
expansion. Building the momentum of the NEST Mark process through
another success is encouraging and we are hopeful more companies
come to the table and discover the cost savings, efficiencies, and
accelerations to be found by partnering through NEST Mark. As our
research network deepens, we look forward to empowering more and
more companies by leveraging RWE that is truly fit-for-purpose and
tailored to individual premarket needs.”
—Simon Mason, President, NEST
About NEST (National Evaluation System for health
Technology)
In 2016, the U.S. Food and Drug Administration (FDA) awarded the
Medical Device Innovation Consortium (MDIC) funding to establish
the National Evaluation System for health Technology Coordinating
Center (NEST). NEST is advancing the use of real-world evidence
(RWE) in medical devices for regulatory decision-making and
committed to transforming the way medical device technologies are
tested, approved, and monitored. The Coordinating Center combines
RWE system infrastructure with the unparalleled expertise of its
network collaborators to accelerate patients’ access to safe and
effective medical technology and provide Quality Evidence by
Design™. For more information, visit http://www.nestcc.org.
About MDIC (Medical Device Innovation Consortium)
At MDIC, we unite in a shared mission to improve health and save
lives by accelerating access to medical technologies. Through
stakeholder collaboration, MDIC leads the way in advancing the
scientific and technical foundations of medical device design,
manufacturing, regulation, reimbursement and clinical integration.
Founded in 2012 as a nonprofit, public-private partnership to
elevate regulatory science, MDIC develops new approaches and tools
for addressing shared challenges among medical device
manufacturers, researchers, regulators, payers, patients, and
health care providers. We deliver high impact work in the core
areas of quality design and manufacturing, evidence generation,
digital technology and transformation, and patient engagement. To
learn more and join us in our mission, visit MDIC.org.
About INTUITIVE
Intuitive, headquartered in Sunnyvale, California, is a global
technology leader in minimally invasive care and a pioneer of
robotic-assisted surgery. At Intuitive, our mission statement is we
believe that minimally invasive care is life-enhancing care.
Through ingenuity and intelligent technology, we expand the
potential of physicians to heal without constraints. Intuitive
brings more than two decades of leadership in robotic-assisted
surgical technology and solutions to its offerings, and develops,
manufactures, and markets the da Vinci surgical system and the Ion
endoluminal system.
Funding for NEST was made possible, in part, by the Food and
Drug Administration through grant (U01 FD 006292).
Views expressed in written materials or publications and by
speakers and moderators do not necessarily reflect the official
policies of the Department of Health and Human Services; nor does
any mention of trade names, commercial practices, or organization
imply endorsement by the United States Government.
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Erica Freeze, Associate Director, Communications
efreeze@mdic.org