Medical Product Outsourcing

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.

Online Exclusives Sam Brusco, Associate Editor 06.09.20

CENTOGENE Releases New Swab Product to Facilitate COVID-19 Diagnosis

The kit has a sterile package containing a swab and collection tube.

Globe Newswire 04.24.20

Cardiovascular

Transcatheter Tricuspid Valve Replacement System Gains Breakthrough Status

Cardiovalve is first company to receive FDA early feasibility study approval for both tricuspid regurgitation and mitral regurgitation indications.

Business Wire 04.17.20

Cardiovascular

Abbott's TriClip Transcatheter Tricuspid Valve Repair Gains CE Mark

The device is delivered to the "forgotten heart valve" through the femoral vein in the leg.

Abbott 04.09.20

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

Cardiovascular

ExThera’s Blood Filter Treats COVID-19 Patients in Europe

Treatments are expected to begin in the U.S. soon.

ExThera Medical 04.06.20

Diagnostics

Fast COVID-19 Tests on The Way

Tests to produce results in five to 15 minutes, cost less than $50, and able to be administered by untrained individuals.

GlobalData 04.03.20

Diagnostics

Haemonetics Acquires enicor to Expand Advanced Viscoelastic Testing

Haemonetics gains ClotPro, a new generation whole blood coagulation testing system.

PR Newswire 04.02.20

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

The Need for Extraordinary Leadership During a Crisis

During these unprecedented times, there have been numerous examples of leadership, both good and bad, from various sources.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.20

Diagnostics

Thermo Fisher's COVID-19 Diagnostic Test Gains CE Mark

Test will now be available for qualified laboratories across the European Union.

PR Newswire 03.26.20

Masimo to Buy Ventilation Firm TNI medical

TNI's softFlow technology provides respiratory gases to spontaneously breathing patients suffering from serious pulmonary conditions.

Business Wire 03.20.20

Paragonix Reports First Successful Use of its SherpaPak Cardiac Transport System

Product is the only FDA-cleared and CE-marked device that safeguards hearts between donor and recipient patients.

Business Wire 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

Diagnostics

Survey: Lack of Access to Diagnostic Tests Has Driven Spread of Coronavirus

CDC reports that more than 22,000 specimens or nose swabs have been taken in the U.S. since the outbreak began, far below other developed countries.

GlobalData 03.17.20

Intact Vascular Expands Tack Endovascular System Portfolio Offering

New larger implant enables focal dissection repair across a wider range of vessel sizes.

Business Wire 03.09.20

Diagnostics

Coronavirus Test Developed for Hologic's Panther Fusion System

German laboratory-developed test uses Panther Open Access functionality.

Business Wire 03.05.20

R&D & Design

Four Considerations for Developers of Next-Generation Combination Products

Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.

Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20

Developing a Plan for Unplanned Crises

It is often assumed C-suite executives are well-trained for every situation and have all the answers, but life seldom adheres to a plan.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 03.04.20

Dawn of a New Decade: Looking Ahead to Medtech’s Future

The start of the '20s offers the industry an opportunity to build value through new tech., collaborations, clinical validations, and value-based outcomes.

Mark Bonifacio, President, BCS LLC 03.04.20

ivWatch Bolsters Intellectual Property and Trademark Portfolios Globally

European and Japanese grants bring owned patents to 27 and additional Israel trademark award brings portfolio to new global audiences.

Business Wire 03.03.20

Contract Manufacturing

Medical Device Contract Manufacturing Market Forecasted to Expand

Reportlinker predicts a high single digit CAGR from 2019 to 2026.

ReportLinker 03.02.20

Cardiovascular | Surgical

Robocath Completes First Robotic Coronary Angioplasties in Germany

R-One received the CE marking in February 2019 and started its clinical application last September.

Robocath 03.02.20

Localization Strategy Key to Competing in Chinese Medtech Market

China is working to increase the share of domestically produced medical devices in hospitals to 70 percent by 2025.

GlobalData 02.28.20

Cardiovascular

Abbott Wins EU Approval for Next-Gen Gallant ICDs, CRT-Ds

Smartphone app and Bluetooth connectivity helps doctors tailor therapy to a patient's clinical needs.

Abbott Laboratories 02.18.20

Diagnostics

AI Assisted Polyp Detector Approved in Europe

Product is expected to debut in the market this spring.

Hoya Group 02.13.20

Cardiovascular

Enrollment Begins in Cagent Vascular's Balloon Catheter Study

Trial will evaluate the safety and efficacy of the Serranator PTA Serration Balloon Catheter in infrapopliteal arteries.

Business Wire 02.12.20

Cardiovascular Systems' Peripheral Orbital Atherectomy Device Debuts in Europe

German patient is the first to be treated with the Stealth 360 Peripheral OAS 1.25 Micro Crown.

Business Wire 02.04.20

Cardiovascular | Contract Manufacturing

Heraeus Medical Acquires CMI

Expands its catheter design, development, and manufacturing capabilities.

Heraeus 02.04.20

Drive systems for medical technology. Reliability when it matters most.

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Cardiovascular

Enrollment Complete in Trial of Arteriovenous Fistula Support Device

VasQ is intended to promote usability of both forearm and upper arm fistulas.

Videos Business Wire

Cardiovascular

Abbott's Tendyne TMVI Gains CE Mark

Eliminates mitral regurgitation when surgery or mitral repair is not an option.

Abbott Laboratories 01.30.20

Industry Assessment: A Roundtable of Medtech Executives

Top medtech executives from across the industry weigh-in on a variety of issues impacting medical device manufacturers.

Sean Fenske, Editor-in-Chief 01.29.20

Electronics

Medtech Connects with Electronic Manufacturing Solutions

IoT, data collection, wearability, connectivity, and miniaturization lead as the demands medtech has of its electronics-centric suppliers.

Mark Crawford, Contributing Writer 01.29.20

20 Factors Medtech Business Owners Need to Consider Before an Exit

Established medtech firm owners may be considering exits for various reasons, such as retirement or the right offer comes in.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 01.29.20

German Device Firm, Aerospace Agency to Study Microgravity Effects on Blood Flow

The research study will examine circulation in blood vessels with a diameter smaller than 100 micrometers.

Presse Box 01.28.20

Surgical

Philips Reveals Upgrades to Mobile C-arm Platform

Zenition's new interface and imaging capability will boost OR workflow.

Philips 01.27.20

FDA Clears Siemens Healthineers SOMATOM X.cite CT Scanner with Intelligent User Interface

myExam Companion automatically adapts scans based on A.I.-trained clinical decision trees to simplify image acquisition parameters and reconstruction tasks.

Business Wire 01.16.20