Simbex

ALung Announces Commercial Development of its Next-Generation Artificial Lung

The next-generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh.

Business Wire 07.08.20

Abiomed Expands Product Portfolio with Breethe Purchase

Abiomed invested in its acquisition target in mid-2019.

Business Wire 07.01.20

How Are MPO’s Top 30 Addressing COVID-19?

J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

Sam Brusco, Associate Editor 06.09.20

Surgical

Low-Cost, High-Accuracy GPS-Like System for Flexible Medical Robots

Performs as well as current state of the art methods, but is much less expensive.

University of California - San Diego

Diagnostics

Gold Standard Diagnostics Launches Multiplex Real-Time PCR Assay for SARS-CoV-2

PCR is the method of choice to detect acute coronavirus infections.

Business Wire 05.18.20

Integra Announces Positive Clinical Results for Bilayer Wound Matrix

Data shows IBWM reduced operating room time and costs associated with lower extremity wounds.

Globe Newswire 05.18.20

Cardiovascular

Impulse Dynamics Appoints Cardiac Electrophysiologist as Medical Director

New executive has spent nearly two decades treating heart failure patients.

Business Wire 05.18.20

Surgical

FDA Issues Warning Letters to Two Breast Implant Makers

Allergan and Ideal Implant Inc. failed to comply with various regulatory requirements.

U.S. Food and Drug Administration 05.15.20

Diagnostics

Hologic Granted EUA for Second COVID-19 Molecular Test

Significant test manufacturing capacity, large installed base of automated instruments yield testing breakthrough.

Business Wire 05.15.20

Diagnostics

FDA Warns About Possible Accuracy Concerns With Abbott Coronavirus Test

Agency claims ID NOW may return false negative results; Abbott says some studies are investigating the test's role in ways it was not meant to be used.

PR Newswire 05.15.20

Dianosic Gains CE Mark for Intranasal Bleeding Treatment Device

Product is the first asymmetric intranasal balloon that stops bleeding by applying low-force compression.

Dianosic 05.15.20

Invacare Sells Dynamic Controls Business to Allied Motion Technologies

As part of the deal, Invacare has entered into a long-term product supply agreement with Dynamic Controls.

Business Wire 05.15.20

Diagnostics

Thermo Fisher Scientific Launches the Cascadion SM Clinical Analyzer

The analyzer has a built-in 25-Hydroxy Vitamin D assay designed to deliver accurate, traceable measurements of Vitamin D2 and D3 fractions.

Thermo Fisher Scientific 05.15.20

Cardiovascular

FDA Clears Expanded Indication for Reflow Medical's Wingman Catheter

The new clearance gives physicians the ability to cross (CTOs) in peripheral lesions.

Business Wire 05.15.20

7 'Expanse-ive' Medical Devices

A medical designer’s (very) informal review of sci-fi props in "The Expanse."

Nigel Syrotuck, Mechanical Engineer Team Lead, StarFish Medical 05.14.20

Emory, Georgia Tech Create COVID-19 Barrier Protection Devices

Aerosol box is designed to contain droplet spray.

Emory University

FDA Grants EUA to UMass' Simpler Ventilator Design

UMass Amherst physicist, global team advance practical device for COVID-19.

University of Massachusetts Amherst 05.14.20

Pathen Medical Announces Availability of New 26-Gauge Nanocath I.V. Catheter

The catheter features kink and occlusion-resistant material, active safety needle encapsulation, and a hub providing added comfort.

Globe Newswire 05.14.20

XCR Diagnostics Secures Patent for Infectious Disease ID Technology

Innovation accelerates detection of diseases such as COVID-19 even on existing PCR testing equipment.

Business Wire 05.14.20

Aspen Surgical Names New CEO

Executive's past work experience includes stints at J&J, Smith+Nephew, and Allen Medical Systems.

Business Wire 05.14.20

Magnolia Medical Secures FDA Clearance for Expanded Steripath Gen2 Products

Devices become the first and only products indicated to reduce blood culture contamination.

PR Newswire 05.14.20

R&D & Design

Medtech R&D Process Aided by Big Data, AI

Digital health allows researchers and engineers to incorporate data sets of user behaviors into their prototypes during the early phases of R&D.

Michael Barbella, Managing Editor 05.13.20

Cardiovascular | Diagnostics | Software & IT

Eko's ECG-Based Algorithm Gains EUA to Boost Heart Failure Detection

Can assist in identifying patients with abnormal heart function during the COVID-19 pandemic.

Business Wire 05.13.20

Cardiovascular

Smiths Medical Expands Vascular Access Offering with Access Scientific Buy

The company acquires the POWERWAND midline and extended dwell catheters.

Business Wire 05.13.20

Neurological | Patient Monitoring

Wearable Device Could Prevent Unexpected Epilepsy Death

Device monitors key biomarkers and then sends a wireless signal to a caregiver when it detects abnormalities.

Purdue University 05.13.20

Viveve Completes Enrollment in Stress Urinary Incontinence Feasibility Study

Three-arm study compares Viveve's Cryogen-cooled Monopolar Radiofrequency treatment and cryogen-only sham to inert sham treatment.

Viveve Medical 05.13.20

Mauna Kea's Next-Generation Cellvizio Platform Receives FDA Clearance, CE Marking

The new platform includes significant improvements and will enable major innovations, such as integrating easily with robotic systems.

Business Wire 05.13.20

Minerva Surgical Acquires Boston Scientific Intrauterine Health Products

Combines the Minerva Endometrial Ablation System with the Genesys HTA Endometrial Ablation System.

PRNewswire 05.12.20

Molex Welcomes New SVP and President

Paul Chaffin joins the company from a Minnesota-based Fortune 500 company.

Phillips-Medisize. 05.12.20

Cardiovascular

FDA OKs Transit Scientific's XO Cross Microcatheter Platform

New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature.

PR Newswire 05.12.20

Cardiovascular | Digital Health

Element Science Raises $145.6 Million Series C Financing

Money will be used to advance the company's next-generation digital wearable platform.

Business Wire 05.12.20

Autocam Medical, University Manufacture Ventilator Splitter With Individual Pressure Capability

Conceived only a few weeks ago, the device can overcome limitation for sharing ventilators.

Autocam Medical 05.12.20

Digital Health | Software & IT

FDA OKs Aidoc's AI Algorithms to Help Detect Findings Associated with COVID-19

Facilitates timely patient workup to allow for activation of COVID-19 related protocols.

PR Newswire 05.11.20

Packaging & Sterilization

'Bug Zapper' UV-C Light Enables N95 Mask Sterilization, Reuse

Can decontaminate 200 N95 masks every eight minutes.

Lehigh University 05.11.20

NASA Low Outgassing Rated Epoxy Features Enhanced Chemical Resistance

Product: EP42-2LV Black

Diagnostics

Mologic and BioSure Partner on COVID-19 Antibody Self-Test

Design is suitable for an at home self-test, giving results in 10 minutes.

Mologic Ltd. 05.11.20

Diagnostics

Vitagene Launches First Authorized Saliva-Based Home Test for COVID-19

Company raises $7 million of additional funding to provide widespread testing to consumers.

Business Wire 05.11.20

Diagnostics

Quidel Receives Emergency Authorization for Rapid Antigen COVID-19 Test

Sofia 2 SARS Antigen FIA Point-of-Care assay offers positive results in 15 minutes.

Business Wire 05.11.20

Forefront Medical Technology Changzhou, PRC Facility Capabilities Overview

Take a tour of Forefront Medical’s state-of-the-art mold fabrication, molding, related fabrication technologies and automated assembly capability in its Changzhou, PRC facility. Forefront has additional engineering and manufacturing capabil…

University's Paper Device Could Provide Portable Coronavirus Detection

Developing a process to manufacture the device, however, would cost at least several million dollars.

Purdue University 05.08.20

Vystar Resumes Production of FDA-Certified UV Light Air Purifiers

CDC states UV-C light is one of the most promising methods for coronavirus disinfection of face masks.

Globe Newswire 05.08.20

Neurological

Light-Based Deep Brain Stimulation Relieves Parkinson's Symptoms

Fast-acting, light-reactive genetic tools could reveal how deep brain stimulation works.

Duke University 04.28.20

Diagnostics

BIOTECON Launches SARS-CoV-2 Screening and Identification Kits

The assays are based on the WHO reference methods.

PR Newswire 04.28.20

Former GE Healthcare Executive Assumes Regulatory Role at IRADIMED

New hire also worked for Merz North America.

Globe Newswire 04.28.20

Masimo and MS Westfalia GmbH Expand Partnership

Companies to add Masimo SedLine Brain Function Monitoring, O3 Regional Oximetry to the MSW modular point-of-care hybrid Jenny.

Business Wire 04.28.20

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.

Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20

Sporting Goods Brand Now Making Millions Of Face Masks

Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.

StringKing 04.27.20

Diagnostics

BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test

Adds automated extraction methods and additional PCR systems.

PR Newswire 04.27.20

Hasbro, Cartamundi Partner to Produce Personal Protective Equipment

Companies to donate 50,000 face shields per week to local hospitals in Massachusetts and Rhode Island.

Business Wire 04.27.20

GlobalData: Medtronic’s MI Business to Exhibit Slow Growth

Aliyah Farouk, Medical Device Analyst at GlobalData offers her view.

GlobalData 04.24.20

Diagnostics

Siemens Healthineers to Expand SARS-CoV-2 Testing

With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.

Siemens Healthineers 04.23.20

Cardiovascular

VisCardia's Heart Failure Therapy Gains Breakthrough Designation

Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.

NewsWire 04.23.20

The Medtech Supply Chain and COVID-19

How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?

Sean Fenske, Editor-in-Chief 04.22.20

Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

The company says it is well positioned for recovery.

Globe Newswire 04.22.20

Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20

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

Diagnostics

bioMérieux Revenue Will Continue to Grow, Says GlobalData

New COVID-19 respiratory panel test is currently in development.

GlobalData 04.20.20

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

Molding

Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding

MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.

Vaupell Midwest 04.16.20

Patient Monitoring

PulseCam Maps Blood Flow

New Rice U. tech could let doctors monitor blood perfusion in real time with a camera.

Rice University 04.13.20

Diagnostics

BD Gains Second EUA for CE-Marked Molecular Diagnostic Test

New test uses BD Max System to augment supply from existing collaborations; test results in under three hours.

BD 04.13.20

Tolomatic Develops Open-Source, Ventilator Actuation Prototypes

The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.

Tolomatic 04.13.20

Industry Events Schedule Disrupted Due to Coronavirus—Full Event List

The medical device manufacturing industry has seen the postponement or cancellation of a number of upcoming events.

Sean Fenske, Editor-in-Chief 03.30.20

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

Medtronic Shares Ventilator Design Specifications

The company aims to accelerate efforts to increase global ventilator production amid COVID-19.

Medtronic 03.30.20

FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test

Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.

Globe Newswire 03.30.20

Diagnostics

FDA OKs Luminex's NxTAG CoV Extended Panel to Detect SARS-CoV-2

BARDA award for $642K helped Luminex accelerate development and validation.

PR Newswire 03.30.20

Battelle Develops Decontamination System for Medical Protective Equipment

Organization receives FDA emergency use authorization to reprocess previously worn PPE.

Business Wire 03.30.20

Diagnostics

Packaging & Sterilization

Mike on Medtech: EtO Sterilization Concerns

Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.

Sean Fenske, Editor-in-Chief 03.30.20

FOLLOW:

YOU SEARCHED BY...

SEARCH BY...

Outsourcing Directory

Country

Outsourcing Directory

Simbex

Company Headquarters

Outsourcing Directory

Medical Device Categories

Related Content

follow us