Anthony Fernando

From Art to Science:  How Machine Learning Is Changing the Surgical Landscape

By MedTech Intelligence Staff

…professionals? Fernando: There are two components to the device: The Senhance system is the robotic component, which includes the robotic manipulation and instrument manipulation. Then there is a complementary part,…

…professionals? Fernando: There are two components to the device: The Senhance system is the robotic component, which includes the robotic manipulation and instrument manipulation. Then there is a complementary part,…

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Elizabeth Holmes

Theranos Founder Sentenced to 11 Years in Prison

By MedTech Intelligence Staff

…in January on three counts of investor fraud and one count of conspiracy to commit fraud related to her blood-testing startup, faced up to 20 years in prison for each…

…in January on three counts of investor fraud and one count of conspiracy to commit fraud related to her blood-testing startup, faced up to 20 years in prison for each…

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FDA

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The…

The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The…

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Sean Hägen
MEDdesign

Why Human Factors Engineering Matters in Medical Device Packaging

By Sean Hägen

…have a profound effect on usability in regard to both risk management and ease of use. For example, packaging can enable intended access to individual components in a purposeful sequence…

…have a profound effect on usability in regard to both risk management and ease of use. For example, packaging can enable intended access to individual components in a purposeful sequence…

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AMA Logo

AMA Releases Blueprint for Optimizing Digitally Enabled Care

By MedTech Intelligence Staff

…Direct investments to companies that work with incumbents to help ensure coordination of care and reduced fragmentation, address needs of vulnerable populations and perform efficacy research of their products.  …

…Direct investments to companies that work with incumbents to help ensure coordination of care and reduced fragmentation, address needs of vulnerable populations and perform efficacy research of their products.  …

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FDA

FDA CDRH Releases Proposed Guidances for 2023

By MedTech Intelligence Staff

…it intends to publish, and a “B-List” of documents it intends to publish as resources permit. In the coming year, the FDA will also reopen for comment select final guidance…

…it intends to publish, and a “B-List” of documents it intends to publish as resources permit. In the coming year, the FDA will also reopen for comment select final guidance…

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Simon Johns
Soapbox

Pharma Needs a New Class of CRM Solutions

By Simon Johns

…or pizza chains, consumers have come to expect near real-time access to the information they need to research a product, make a purchase or ask a question. Companies that succeed—no…

…or pizza chains, consumers have come to expect near real-time access to the information they need to research a product, make a purchase or ask a question. Companies that succeed—no…

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Ronnie-Mahofski

RQM+ Appoints Mahofski as Head of Mergers and Acquisitions

By MedTech Intelligence Staff

…project manager for MEDRAD. In his new role at RQM+, Mahofski is responsible for identifying and pursuing acquisition opportunities that complement its core regulatory services and provide a comprehensive range…

…project manager for MEDRAD. In his new role at RQM+, Mahofski is responsible for identifying and pursuing acquisition opportunities that complement its core regulatory services and provide a comprehensive range…

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FDA

FDA Updates Breakthrough Devices Guidance Focused on Health Equity

The FDA has issued a new draft guidance: Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. The Breakthrough Devices Program is a voluntary…

The FDA has issued a new draft guidance: Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. The Breakthrough Devices Program is a voluntary…

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Renato Rjavec

Preparing for a Data-first Regulatory World

By Renato Rjavec

…skill sets now need to be refreshed to reflect the target new ways of working. Early-mover Advantage With the exception of very large pharma organizations, most companies still lack awareness…

…skill sets now need to be refreshed to reflect the target new ways of working. Early-mover Advantage With the exception of very large pharma organizations, most companies still lack awareness…

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