Medical Product Outsourcing

Software & IT

Adopting a Data-Driven Quality Model

Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.

Online Exclusives David Jensen, Staff Writer, MasterControl 04.09.21

Chronic Disease | Digital Health | Patient Monitoring

CGM: Digital Health Meets a Very Large Opportunity

Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.

Maria Shepherd, President and Founder, Medi-Vantage 04.01.21

Harnessing Critical Health Data With Wearable Technology

Optical biosensors could open new doors for front-end patient care.

Online Exclusives Robert Newberry and Matthew Rodencal, Sanmina Corporation 03.26.21

Software & IT

2021: The Year for Insights Into Quality Data

For users of paper-based quality systems, data can seem overwhelming and disorganized.

Online Exclusives Sarah Beale, Staff Writer, MasterControl 03.11.21

Chronic Disease | Digital Health | Software & IT

Brainlab Buys Mint Medical to Boost Quality of Clinical Routine, Research Data

Will improve radiological report automation through AI and anatomical mapping, create unparalleled longitudinal data.

Sam Brusco, Associate Editor 03.10.21

A Look at the Actual Device Costs for Hospitals

According to a 2018 clinical journal article, U.S. hospitals spent approximately $200 billion on medical devices.

Maria Shepherd, President and Founder, Medi-Vantage 03.04.21

FDA Making Progress With Technology and Data Action Plans

There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

Alan Rencher, Vice President, Engineering, MasterControl 03.04.21

Surgical

Rethink Your Medtech ASC Strategy, Part 1

ASCs have adopted a strategy to focus on predictable, low-risk procedures with lower complication rates in an out-of-hospital setting.

Maria Shepherd, President and Founder, Medi-Vantage 02.03.21

COVID-19: Accelerator of a Modern, Data-Driven Supplier Strategy

By the time COVID-19 arrived in the United States, global supply chains were already buckling under a historic level of demand.

Denise Odenkirk, Vice President, Supplier Sales, Global Healthcare Exchange LLC 02.03.21

Study Data Demonstrates Safety of MONARCH Platform

The MONARCH Platform localized targeted nodules using a combination of direct visualization, navigational guidance, and radial endobronchial ultrasound.

Michael Barbella, Managing Editor 02.02.21

Cardiovascular | Surgical

Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

There were no incidences of structural valve deterioration at the five-year mark.

Sam Brusco, Associate Editor 02.01.21

Data Protection, Security Should be Top Priorities for Medtech During Pandemic

The coronavirus crisis has prompted a rising number of cyberattacks on hospitals, research facilities, and health systems.

Michael Barbella, Managing Editor 01.28.21

Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

Michael Barbella, Managing Editor 01.22.21

Optimize EP Launches CaRM Cardiac Device Data Management Platform

Digital tool automates workflow processes and enhances data algorithms to efficiently improve patient care.

Accesswire 01.15.21

FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.

PR Newswire 01.14.21

Rapid Screening App Uses Wearable Sensor Data to Detect COVID-19 Infection

New screening tool proves almost twice as effective as temperature checks in predicting coronavirus.

NeuTigers 01.13.21

New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System

The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.

B3C newswire 01.08.21

VivaLNK Expands its Medical Data Platform

The platform boasts more than 90 healthcare solution partners across 22 countries amid an increase in remote patient monitoring adoption.

VivaLNK 01.07.21

Rapid Adoption of AI Could Cause Problems Due to Biased Data

Some algorithms designs could ignore how numerous factors such as sex, gender, age or existing conditions can impact health.

GlobalData 12.07.20

Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon

No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.

Royal Philips 12.03.20

First National Pediatric Cardiac Screening Database is Established

FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening.

Business Wire 11.30.20

Chronic Disease

Medtronic Launches InPen with Real-Time Guardian Connect CGM Data

Real-time glucose data coupled with InPen’s dose calculator helps users make better dosing decisions.

Medtronic plc 11.12.20

Chronic Disease

Varian Invests $10M in COTA to Boost Data-Driven Cancer Care

Companies will work together to empower cancer clinics with data analytics and decision support tools.

PR Newswire 11.10.20

Electronics

Big Data's Role in Sensor Design

Insight into device use is driving trends in miniaturization, low-power options, and conversion to digital sensing.

Online Exclusives Michael Barbella, Managing Editor 11.09.20

physIQ, Purdue University Studying Feasibility of COVID-19 Detection Through Smartwatch Data

Data from the study will inform new algorithms to be developed by physIQ, a Purdue-affiliated digital health technology company.

Business Wire 11.09.20

Report: Nearly Three-Quarters of mHealth Apps Vulnerable to Data Breach

Findings also conclude that a majority of mHealth apps contain multiple security issues with data storage.

Business Wire 11.05.20

Cardiovascular

The Heart of the Matter: Trends in Cardiology

Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.

Maria Shepherd, President and Founder, Medi-Vantage 11.04.20

ERT and Science 37 Partner to Deliver High-Quality Data During Virtual Trials

Alliance enables trial sponsors to improve imaging, respiratory, and cardiac safety data quality while reducing patient burden and risk.

ERT 10.08.20

Digital Health

Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials

Medidata Detect identifies known and unknown risks, and triggers corrective actions.

Business Wire 10.05.20

Surgical

Hype or Hope? The Future of Surgical Robotics

Recent publications suggest the U.S. performs more robotic surgery than every other country in the world.

Maria Shepherd, President and Founder, Medi-Vantage 10.01.20

Software & IT

Adopting a Data-Driven Approach to Quality with an MDQMS

FlexLogical is making quality a competitive advantage through its software solution.

Online Exclusives Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20

RapidAI Marks One Millionth Scan Leveraging Big Data

The milestone gives RapidAI the ability to leverage more statistical power and data to enhance performance and improve patient care.

Business Wire 09.22.20

Diagnostics | Electronics

Smart E-Skin, Robotic Hand Could Gather Vital Diagnostic Data

Relies on easily manufacturable rubber semiconductor.

University of Houston 09.17.20

Neurological

Gentle Probes Could Enable Massive Brain Data Collection

NIH awards $4.15 million grant to maximize use of devices based on flexible nanoelectronic thread.

Mike Williams, Rice University 09.16.20

Diagnostics

FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data

Shows Limit of Detection of over 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel.

U.S. Food and Drug Administration 09.16.20

Contract Manufacturing | R&D & Design

Trends for Medtech Contract R&D and Manufacturing

Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.

Maria Shepherd, President and Founder, Medi-Vantage 09.01.20

Cardiovascular

Data Reconfirms Long-Term Safety of Philips Stellarex Low-Dose Drug-Coated Balloon

The mortality rate at four years shows no statistical difference between two patient groups.

Royal Philips 08.27.20

Cardiovascular

Elixir Medical Touts Positive 12-Month Data for DynamX Coronary Bioadaptor System

Data show no target vessel revascularization, no thrombosis, and positive adaptive remodeling of the artery.

Business Wire 08.26.20

Real-World Data for Medtech Approval Reduces Time to Market in China

The Chinese market is forecast to grow 5.6 percent over the next five years.

GlobalData 08.05.20

Study Data for LimFlow System Shows Excellent Amputation-Free Survival

The minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood into the foot via the veins.

Business Wire 07.20.20

Cardiovascular

FDA Approves Data Streaming from Abiomed's Impella Console

Sets the stage for AI algorithms to further improve patient outcomes.

Business Wire 07.17.20

Diagnostics

FDA to Harness Real-World Data to Inform COVID-19 Response Efforts

The FDA will participate in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.

U.S. Food and Drug Administration 06.19.20

Software & IT

Avoiding the Ripple Effect of Bad Data: Humans and Machines

Part 3: Using process automation to reduce human error.

Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20

Software & IT

Avoiding the Ripple Effect of Bad Data: Systems and Data

Part 2: Integrating disconnected data systems.

Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20

Software & IT

Avoiding the Ripple Effect of Bad Data: Quality and Manufacturing

Part 1: Why going paperless is essential.

Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20

Chronic Disease

Diagnostics

FDA Publicly Shares Antibody Test Performance Data

Advancing access to trustworthy tests and the wider field of research into serology testing.

U.S. Food and Drug Administration 06.05.20

Digital Health

Hospital Advances in Digital Health Medical Technology

It's been stated, “What the world would have taken five years to achieve was accomplished in five weeks,” regarding virtual care and the U.S. population.

Maria Shepherd, President and Founder, Medi-Vantage 06.04.20

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