Medical Product Outsourcing

Cardiovascular | Surgical

FDA OKs AngioDynamics' AlphaVac Mechanical Thrombectomy System

Non-surgical removal of thrombi or emboli from the vasculature.

Sam Brusco, Associate Editor 06.08.21

Surgical

Biomechanical Engineer, Heal Thyself

Choosing a treatment option for spinal disorders can be tricky with extensive knowledge of the industry.

Dawn A. Lissy, Founder & President, Empirical 04.01.21

Diagnostics

Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

The assay is currently available in Europe.

Michael Barbella, Managing Editor 02.16.21

Cardiovascular

Philips Releases QuickClear Mechanical Thrombectomy System for Blood Clot Removal

Significantly smaller footprint provides the same or greater aspiration power as currently available thrombectomy devices.

GlobeNewswire 09.25.20

Patient Monitoring

FDA Clears Masimo's PVi Perfusion Measure for Mechanically Ventilated Patients

PVi, or pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

Business Wire 08.14.20

Getinge's Servo-air Mechanical Ventilator Receives 510(k) Clearance

Includes both Invasive and Non-Invasive (NIV) ventilation modes.

Getinge 07.07.20

FDA OKs ALung Hemolung Respiratory Assist System to Treat COVID-19

Hemolung can be a valuable tool to be used in conjunction with invasive mechanical ventilation.

Business Wire 04.27.20

R&D & Design

Medtech R&D Must Address Outcomes in Value-Based Care

Clinical requirements are no longer the only cornerstone of medical device development.

Online Exclusives Michael Barbella, Managing Editor 04.24.20

Health Canada Expands Emergency Use of CeraShield Endotracheal Tube

May help prevent deadly ventilator-associated bacterial infections and complications in COVID-19 patients.

PR Newswire 04.24.20

Diversified Plastics Increases Capacity of Acceleration Station to Meet Manufacturing Demand

The Station’s engineering and production teams work closely with customers to save time and money by optimizing parts for digital manufacturing.

Diversified Plastics Inc. 04.23.20

Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19

The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.

Globe Newswire 04.22.20

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

3D/Additive Manufacturing | Diagnostics

3D-Printed Swabs Could Help Fill Gap in COVID-19 Test Kits

Clinical trials expected to begin by the end of this week.

University of Louisville 04.17.20

Diagnostics

Blood Test May Help Doctors Catch Pancreatic Cancer Early

Penn study shows liquid biopsy may be viable option for both diagnosis and disease staging.

Penn Medicine 04.16.20

Cardiovascular | Electronics | Patient Monitoring

Lung-Heart Super Sensor on a Chip Tinier Than a Ladybug

The chip acts as an advanced electronic stethoscope and accelerometer in one.

Georgia Tech 04.16.20

Digital Health | Patient Monitoring

GE Healthcare Deploys Remote Patient Data Monitoring for COVID-19

Numerous ventilated patients can be viewed simultaneously and remotely; enables early identification of patients at risk of deterioration.

Business Wire 04.15.20

CMU-Developed Microneedle Patches Ready for COVID-19 Fight

Currently seeking researchers who are working on a vaccine against, or treatment for, SARS-CoV-2 to collaborate.

Videos Lisa Kulick, Carnegie Mellon University

Non-Invasive Ventilators Offer Life-Saving Treatment for Less Severe COVID-19 Patients

Manufacturers could produce more than 60,000 per week, easing pressure on the system.

AdvaMed 04.09.20

MedLite ID Appoints New Board Chairman, COO/CFO

Company founder is associated with over 100 patents ranging from mechanical devices, dental products, medical devices, and medical software products.

PR Newswire 04.08.20

3D/Additive Manufacturing

Materialise's 3D Printed Oxygen Mask Helps Ventilator Shortage

COVID-19 solution brought to hospitals quickly and in full compliance with safety regulations.

Videos Materialise

Prisma Health, Ethicon to Make Ventilator Expansion Device

The VESper Ventilator Expansion Splitter Device is authorized for emergency use only during the COVID-19 pandemic.

Prisma Health 04.06.20

MIT Begins Mass Manufacture of Disposable Face Shields

A team from MIT has designed disposable face shields that can be mass-produced.

Videos Mary Beth Gallagher, Department of Mechanical Engineering, Massachusetts Institute of Technology

Cardiovascular

VADovations Secures Investment, Development Agreement for Percutaneous Endovascular Delivery System

Product is designed to avoid open surgical implantation while addressing the limitations of current blood pumps.

Business Wire 04.03.20

Emergency Use Authorization Granted for N8 Medical CeraShield Endotracheal Tubes

The tubes have anti-fouling coating designed to prevent deadly bacterial infections that occur in ventilated patients with respiratory viral infections.

PR Newswire 04.03.20

Mack Molding Names Vice President of Business Development

Company also has added positions and/or promoted workers in quality, business development, customer management, manufacturing, purchasing and human resources.

Mack Molding 04.02.20

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

Tubing & Extrusion

Pathways to Care: Tubing Technologies

Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.

Mark Crawford, Contributing Writer 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

Former Boston Scientific Marketing Director Joins CorWave Board

New board member also worked for Medtronic and Avedro.

Business Wire 04.01.20

Diagnostics

Siemens Healthineers’ RAPIDPoint 500e Blood Gas Analyzer Cleared

The analyzer is used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.

Siemens Healthineers 03.31.20

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

3D/Additive Manufacturing | Neurological

3D Printed Soft, Rubbery Brain Implants

Technique may enable speedy, on-demand design of softer, safer neural devices.

Massachusetts Institute of Technology 03.30.20

3D/Additive Manufacturing

Risks of Using 3D Printing to Make Personal Protective Equipment

There are a lot of issues with certain types of 3D printed parts with respect to their use in a clinical setting.

Mary Beth Gallagher, Department of Mechanical Engineering, Massachusetts Institute of Technology 03.27.20

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

Chronic Disease | Diagnostics

Crumpled Graphene Makes Ultra-Sensitive Cancer DNA Detector

Crumpling graphene makes it more than ten thousand times more sensitive to DNA.

University of Illinois at Urbana-Champaign, News Bureau 03.24.20

4 Medical Manufacturing Trends Driving Growth in 2020

Medical device manufacturing is poised for 5.6 percent growth each year between 2017 and 2023.

Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 03.17.20

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

Cardiovascular

Ancora Heart Expands U.S. Early Feasibility Study

CorCinch HFrEF study is evaluating the safety of AccuCinch Ventricular Repair System in heart failure patients.

Business Wire 03.12.20

Materials

A Matter of Substance: Medical Device Materials

Medtech manufacturers are leveraging cleaner, more lightweight materials to meet increasing demand for home healthcare solutions and wearable devices.

Michael Barbella, Managing Editor 03.04.20

Cardiovascular

Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies

Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.

Sam Brusco, Associate Editor 03.04.20

Cardiovascular