Jennifer Kent
Soapbox

Empowering Patients Through RPM

By Jennifer Kent, Ph.D.

…and diagnostic support. Examples of use cases powered by AI and algorithms include the ability to algorithmically compare patient trajectories, proactively identify and avoid health crises, triage at-risk patients, diagnose…

…and diagnostic support. Examples of use cases powered by AI and algorithms include the ability to algorithmically compare patient trajectories, proactively identify and avoid health crises, triage at-risk patients, diagnose…

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Jaishankar Kutty

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

By Jaishankar Kutty, Ph.D.

…Different processing or cleaning agent Different “minor” component Different colorant For each different material or component, manufacturers should be able to explain the role of the material/component in relation to…

…Different processing or cleaning agent Different “minor” component Different colorant For each different material or component, manufacturers should be able to explain the role of the material/component in relation to…

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Pixabay Hearing Aid

FDA Establishes OTC Hearing Aid Category

By MedTech Intelligence Staff

…while assuring the safety and effectiveness of OTC hearing aids and fostering innovation and competition in the hearing aid technology marketplace. Subscribe to the weekly MedTech Intelligence newsletter to stay…

…while assuring the safety and effectiveness of OTC hearing aids and fostering innovation and competition in the hearing aid technology marketplace. Subscribe to the weekly MedTech Intelligence newsletter to stay…

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Andrew Lacy
Soapbox

American Health Care Has a Diagnostics Problem

By Andrew Lacy

…Diagnostics There are more than 4,000 different tests on the market today that can detect illnesses early, before they become life threatening. From blood tests that detect fragments of cancer…

…Diagnostics There are more than 4,000 different tests on the market today that can detect illnesses early, before they become life threatening. From blood tests that detect fragments of cancer…

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UPS

UPS To Expand Healthcare Logistics Services with New Acquisition

By MedTech Intelligence Staff

…newest healthcare innovations,” said UPS Healthcare President Wes Wheeler. “We are excited to combine Bomi’s talent, expertise and capabilities with UPS Healthcare—together, we will provide unmatched solutions to our customers,…

…newest healthcare innovations,” said UPS Healthcare President Wes Wheeler. “We are excited to combine Bomi’s talent, expertise and capabilities with UPS Healthcare—together, we will provide unmatched solutions to our customers,…

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Standard literature review lifecycle

Evidence Partners AI-Based SLR Platform Attracts $20 Million in Growth Financing

By MedTech Intelligence Staff

company will further invest in go-to-market initiatives to ensure that the global research community is aware of and can access this important technology.” “The Evidence Partners team has built an…

company will further invest in go-to-market initiatives to ensure that the global research community is aware of and can access this important technology.” “The Evidence Partners team has built an…

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Helen Lowe
CAPA Corner

CAPA Management Can Save Resources and Reduce Expenses

By Helen Lowe

No company can improve its performance if it does not fundamentally recognize and understand its errors and failures. This approach entails a change of mindset under which failures should not…

No company can improve its performance if it does not fundamentally recognize and understand its errors and failures. This approach entails a change of mindset under which failures should not…

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Employee Coaching

CDRH Seeks Medical Device Sites for Review Staff Education

By MedTech Intelligence Staff

…and encourages the submission of proposals addressing Patient Engagement as a supplemental topic. Companies that would like to take part in ELP can apply as part of the 2023 ELP…

…and encourages the submission of proposals addressing Patient Engagement as a supplemental topic. Companies that would like to take part in ELP can apply as part of the 2023 ELP…

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Leon Hendra

The Case for In-Person Work: Making Human Connections

By Leon Hendra

…many companies don’t do a good job of explaining why. Data combined with communicating a solid strategy can help overcome this challenge, while incentives can help attract and retain talent….

…many companies don’t do a good job of explaining why. Data combined with communicating a solid strategy can help overcome this challenge, while incentives can help attract and retain talent….

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Jordanna Jayne

Realizing the Promise of Real-World Evidence in MedTech

By Jordanna Jayne, Ph.D.

…unstructured data may be required to obtain regulatory grade data, i.e., complete and high-quality data obtained through a transparent and robust study design, including provenance, veracity and traceability of the…

…unstructured data may be required to obtain regulatory grade data, i.e., complete and high-quality data obtained through a transparent and robust study design, including provenance, veracity and traceability of the…

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