Medical Product Outsourcing

R&D & Design

User Evaluation in the Absence of User Data with Platform Devices

Accurate identification of the intended user population is not an option here.

Finola Austin, Human Factors Engineering Manager, Owen Mumford 05.03.21

Digital Health

How Can a Device End User Aid in Cybersecurity?

MPO's Sean Fenske gets tips from Alan Grau of Sectigo about how a medical device end user, whether physician or patient, can help ensure the unit is secure.

Videos Sean Fenske, Editor-in-Chief

Digital Health

Senseonics Launches New Remote Monitoring App for Android Users

Real-time glucose data and alerts of Eversense CGM users can now be remotely monitored on Android or iOS operating system.

Business Wire 07.27.20

Chronic Disease

One Drop Unveils New AI Predictions for CGM Users

Announces long-term outcomes forecasts for diabetes-related biomarkers and overnight hypoglycemia predictions.

PRNewswire 06.15.20

MedSolace Releases COVID-19 Calculator That Estimates Users' Outcomes

App stratifies users as high, moderate or low risk based on their complication rate from a potential COVID-19 infection.

MedSolace Inc. 05.04.20

Medtech’s Battle on Multiple Fronts Against COVID-19

From PPE to testing to ventilator solutions, medtech firms are trying to find answers for healthcare’s needs against the novel coronavirus.

Online Exclusives Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20

Surgical

FDA Update on Essure Postmarket Activities

All unused Essure devices of which Bayer is aware have been returned to the company.

U.S. Food and Drug Administration 04.27.20

Integrity Applications Closes $15 Million Private Placement

Shares were sold for 40 cents each.

Globe Newswire 04.22.20

Patient Monitoring | Surgical

Brainlab's ExacTrac Dynamic Patient Positioning, Monitoring Gains CE Mark

New 4D thermal surface tracking combined with flagship X-ray technology increases versatility.

Business Wire 04.21.20

Diagnostics

ELITechGroup MDx, OSANG Healthcare Receive Emergency Use Authorization for COVID-19 Test Kits

Test delivers qualitative results within hours.

PR Newswire 04.20.20

Surgical | Testing

Medical Robots: Assessing Safety and Performance in a Growing Field

Be aware of potential hazards robots may present and testing options to address them.

Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20

FDA Continues User-Fee Related Reviews Through COVID-19

FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.

U.S. Food and Drug Administration 04.17.20

Digital Health

Viz.ai Adds Next-Generation Functionality to Artificial Intelligence Stroke Platform

New capabilities allow the stroke care team to synchronize care from stroke code notification to the post-acute care period.

Business Wire 04.16.20

Chronic Disease | Digital Health

One Drop Acquires Health Sensing Firm Sano

Sano continuous glucose sensing platform will live on in a comprehensive multi-sensorial solution from One Drop.

PR Newswire 04.13.20

Packaging & Sterilization

FDA OKs STERIS Systems to Decontaminate N95 Respirators

Will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

U.S. Food and Drug Administration 04.13.20

Chronic Disease | Patient Monitoring

FDA OKs Abbott's FreeStyle Libre CGM Use in Hospitals

Remotely monitors patients with diabetes to minimize exposure to COVID-19.

PR Newswire 04.08.20

Surgical

Sharp Fluidics Acquires neoClose Laparoscopic, Robotic Port Closure Technology

neoClose utilizes bio-absorbable anchors with a pre-attached suture.

PR Newswire 04.08.20

Software & IT

Seeking Software Partners During a Crisis

The COVID-19 pandemic has caught many unprepared to handle increased challenges, leaving them to find assistance.

Online Exclusives Svetlana Anishchenko, Director of Marketing, Auriga Inc. 04.07.20

Polyzen Helps to Address Shortage of PPE

Commits to assist manufacturers, hospitals, and other healthcare facilities in getting the supplies they need.

Polyzen 04.03.20

R&D & Design

Examining the Usability of Medical Software

Developers need to consider the ‘human factor’ when it comes to testing medical device software.

Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20

Software & IT

Validating Your QMS the ‘EZ Way’

Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.

James Shore and Roxana Rosales 04.01.20

Digital Health

Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

Michael Barbella, Managing Editor 04.01.20

Medtech Innovation and Adaptation in a Changing Pharmaceutical Landscape

The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined.

Tom McLean, VP, Development Engineering, R&D Innovation & Technology, West Pharmaceutical Services 04.01.20

The Economics of a Sound Regulatory Strategy

While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.

Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20

R&D & Design

Supercharge Medical Device Innovation Using Effective User Preference Studies

User preference and evaluation studies have been a mainstay design tool for medical device development for decades.

Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 04.01.20

Patient Monitoring

Essity Buys Smart Ultrasound Technology for Incontinence

Novioscan's SENS-U monitors the bladder and enables continence control.

PR Newswire 04.01.20

Diagnostics | Digital Health

DetectaChem Creates First Mass-Market Smartphone COVID-19 Test Kit

Company's detection technology provides test results for COVID-19 detection in minutes through an automated smart phone app.

Globe Newswire 04.01.20

R&D & Design

Rice Joins U of U-Led Human Factors Consortium

Brings new expertise to the consortium, led by University of Utah.

University of Utah 03.30.20

SHL Medical Buys Weibel CDS

Autoinjector firm acquires packaging technologies and delivery systems for parenteral drugs.

PR Newswire 03.30.20

Patient Monitoring

Medtronic Launches New Solutions to Monitor COVID-19

Helps assess, monitor, and triage support for patients concerned about COVID-19 and respiratory symptoms.

GlobeNewswire 03.27.20

Digital Health

MyTelemedicine Rolls Out Rapid Response Virtual Care Platform

Healthcare providers can meet increased patient demand in the face of COVID-19 by using a cloud-based telehealth platform.

PR Newswire 03.26.20

FDA Grants Expanded Emergency Use Access for COVID-19 Nitric Oxide Treatment

The recently approved GENOSYL from VERO Biotech inhaled nitric oxide may have pulmonary and antiviral benefits in treating coronavirus-infected patients.

PR Newswire 03.26.20

Nu-Med Plus Monitoring Outcomes on COVID-19 Treatment Trials

Inhaled nitric oxide has been used in the past as a supportive measure in treating coronavirus-infected patients.

Globe Newswire 03.25.20

Digital Health

MobileSmith Health's Mobile Apps Support Hospital Response to COVID-19

Apps allow hospitals to share reliable, accurate information on the coronavirus pandemic with the community, hospital employees, and volunteers.

Globe Newswire 03.24.20

FDA Relaxes Ventilator Oversight in Effort to Boost Supply

The measure will help expand the availability of devices that facilitate respiration, including ventilators and accessories during pandemic.

U.S. Food and Drug Administration 03.23.20

Vapotherm Receives CE Mark for Oxygen Assist Module

Product helps clinicians keep patients within the target oxygen saturation range more effectively than with manual control alone.

Business Wire 03.19.20

Diagnostics | Software & IT

App Spots Harsh Breast Cancer Treatment Side Effect

LymphaTech app detects early arm swelling associated with lymphedema in breast cancer patients.

Georgia Institute of Technology 03.17.20

Carestream Health Earns 37 U.S. Patents in 2019

Total worldwide patents amounted to 75 last year.

Business Wire 03.16.20

Diagnostics

FDA OKs Meridian Bioscience's Curian Analyzer and HpSA Assay

Curian and Curian HpSA are designed to quickly detect Helicobacter pylori antigens.

GlobeNewswire 03.16.20

Nihon Kohden Launches NKV-550 Series Ventilator System

Product was developed to seamlessly transition between invasive ventilation, noninvasive ventilation, and high-flow oxygen therapy.

Business Wire 03.11.20

Software & IT

Realizing Production Efficiency Through ERP Solutions

Medical product outsourcers share insights and best practices through a survey of manufacturers that’s centered around their outlook for 2020.

Louis Columbus, Principal, IQMS/DelmiaWorks 03.04.20

Testing

The Importance of Usability/Human Factors Testing

When is the work of human factors over, and how does your team know they are prepared for summative testing?

Maria Shepherd, President and Founder, Medi-Vantage 03.04.20

Software & IT

Expanding Quality Beyond the Four Walls of Your Organization

As suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity.

Seth Goldenberg, Ph.D., and Carl Ning, Veeva Systems 03.04.20

Software & IT