NAMSA Acquires Syntactx, Joining Together to Form the Industry’s Leading Medical Device CRO
NAMSA is the World’s Only 100% Medical Device-Focused CRO offering global end-to-end development solutions…
DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE…
FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS COMPARED TO INDUSTRY AVERAGES…
HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967.
Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.
Offering product development strategy; medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes.
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Always on the pulse of industry news, we interpret the latest regulatory guidelines and other medical device updates so you don’t have to. Learn what recent news means for your medical device development plans and commercial operations.
Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released the Rule, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary.” This is a major development regarding how large U.S. payers will be reimbursed for innovative technologies, beginning March 15, 2021.
U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan
In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health technologies, on January 12, 2021, the Agency released their first Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan.
U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices
In step with the Breakthrough Devices Program, and the Agency’s promise to introduce additional programs that promote earlier access to life-changing devices, the U.S. FDA introduced the Safer Technologies Program (“STeP”) on January 6, 2021. The FDA’s latest program is intended for 510(k), De Novo or PMA devices that do not meet Breakthrough Devices Program criteria, but still have an important role in the treatment of lesser life-threatening or debilitating diseases/conditions and bring significant benefits to patients.
NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise
NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.
New Guidance: Classification of IVD under the IVDR
On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union.
Let NAMSA’s medical device development experts guide you in the right direction.