Medical Product Outsourcing

Trump Signs Bill Replenishing Coronavirus Relief Funding

Legislation provides $484 billion for company payrolls, hospitals, small business loans, and a national testing system.

Staff and Wire reports 04.24.20

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

Contract Manufacturing

A Valuable Supply Chain Lesson, Courtesy of Coronavirus

The deadly respiratory disease spreading like wildfire around the world is exposing major weaknesses in the global medtech supply chain.

Michael Barbella, Managing Editor 03.04.20

Medical Device Tax Is Officially Eliminated

President Trump signed into law the 2020 spending bill, repealing the tax.

Sam Brusco, Associate Editor 12.23.19

Trump Picks MD Anderson Doctor to Lead FDA

Nominee is chief medical executive at the center, but has never before worked in government.

MPO Staff Report 11.01.19

Google to Buy Fitbit for $2.1 Billion

Deal is expected to close next year.

Business Wire 11.01.19

Study Examines Ability of Masimo's Noninvasive, Continuous Hemoglobin to Detect Anemia Earlier

Researchers found a mean delay in the detection of anemia.

Business Wire 11.01.19

FDA Approves Clinical Study of LimFlow's MI Amputation Prevention Technology

The study will be conducted in the United States and Japan.

Business Wire 10.31.19

Diagnostics

A Timely Triage Test for TB

New blood test could help millions of people infected with tuberculosis.

Videos Lindsay Brownell

Masimo Develops Delta cHb, HHb, and O2Hb Indices for O3 Oximetry

O3 uses near-infrared spectroscopy (NIRS) to monitor and display continuous rSO2 values for each side of the brain.

Business Wire 10.22.19

Nocira Awarded Fifth Patent for its Migraine Treatment Technology

Company's approach uses gentle air pressure changes in the ears to relieve symptoms.

Nocira LLC 10.18.19

Diagnostics

Cytek Biosciences’ Receives Chinese Approval for Clinical Use of its Northern Lights Platform

Company working to make complete spectral flow Cytometry Solution available to the Chinese market.

Globe Newswire 10.16.19

Diagnostics

Blood Test May Help Accelerate Brain Cancer Diagnosis

Could improve patient quality of life and survival.

University of Strathclyde 10.09.19

Diagnostics

Thermo Fisher Scientific Unveils New Krios Solution

Product speeds the path to disease understanding through improved ease-of-use and faster results.

PR Newswire 09.27.19

Surgical

Powered Circular Stapler for Colorectal, Gastric, Thoracic Surgery Launched by Ethicon

New ECHELON CIRCULAR Powered Stapler results in 61 percent fewer leaks at the staple line.

Johnson & Johnson 09.24.19

Cardiovascular

Dassault Systèmes Extends FDA Collaboration on Cardiovascular Device Review Process

Extension aims to spur medical device innovation by enabling innovative, new product designs.

Business Wire 09.18.19

OS-SiA, a Next-Gen AI-Enabled Digital Scanner, is Launched by OptraSCAN

Smart scanner is designed to scan and analyze tissue at the same time.

Business Wire 09.11.19

Methods Machine Tools Introduces its Own Brand of Vertical Machining Centers

The centers are now available in North America.

Methods Machine Tools 09.03.19

Molding

Polymer Resources Expands Custom Color Service

Company makes investments in injection molding equipment and technical staff.

Polymer Resources Ltd. 08.30.19

Cognito Therapeutics Appoints Chief Scientific Officer

New hire has an accomplished background in both the medtech industry and academia.

Business Wire 08.13.19

Cardiovascular

Philips Extends Advanced Automation Capabilities on its EPIQ CVx Cardiology Ultrasound Platform

Platform provides advanced automation for right ventricle volumes and ejection fraction measurements in as little as 15 seconds, speeding exam times.

Royal Philips 08.07.19

Pre-Pilot Trial From Ocutrx Vision Technologies Yields Promising Results for Patients With AMD

New Oculenz headset enhances functional vision for patients with severe age-related macular degeneration.

Ocutrx Vision Technologies 08.02.19

SyncThink Expands IP With Patent for Content Adaptation to Subject’s Attention Using Eye Tracking

New patent to allow assessment of a patient’s attention by using eye tracking technology to change the rate of content delivery to match attention levels.

SyncThink 07.31.19

Radiotherapy Patient Positioning Accessories Industry to Focus on Stronger Distribution Networks

More than 40 percent of the total adoption of radiotherapy patient positioning accessories is registered by hospitals at a global level.

Future Market Insights 07.26.19

Contract Manufacturing

Turning a Regulatory Headache into a Competitive Advantage

Understanding 21 CFR Part 11 and EU Annex 11 compliance.

Online Exclusives David Kralovetz, Cincinnati Test Systems 07.23.19

Study Confirms Significant Medication Reduction After Implantation of Glaukos iStent inject

iStent inject achieved 42 percent reduction in Mean IOP to 14.6 mmHg and 82 percent reduction in mean medications to 0.55 at three years postoperative.

Business Wire 07.23.19

obp Launches Single-Use, Cordless Surgical Retractor with Integrated Multi-LED Light Source

ONETRAC LX delivers a fully integrated cordless surgical retractor for surgeons performing demanding procedures requiring greater illumination strength.

Business Wire 07.17.19

Cardiovascular

Analysis Shows ACIST CVi System Lowers Costs, Improves Patient Safety for Coronary Catheterizations

An economic model analysis demonstrates $464,498 in annual cost-savings to hospitals based on 3,500 annual coronary procedures.

PR Newswire 07.15.19

IRIDEX Corporation Names President and CEO

New leader has held several chief executive and leadership positions in public and private medical device growth-stage companies.

Globe Newswire 07.11.19

Glytec Awarded Patent Allowance for Virtual Insulin Titration in Concert With CGM and Smart Pens

Company's digital platform offers primary care providers the means to use CGM data to formulate timely and discrete dosing recommendations.

Business Wire 07.05.19

Neurological | Patient Monitoring

Augmented Reality Glasses Can Help See Patients' Real-Time Pain in the Clinic

The technology was tested on 21 volunteer dental patients.

University of Michigan 07.01.19

Cardiovascular

Embolx Extends the Sniper Balloon Occlusion Microcatheter Family With Launch of New K-Tip Design

New shaped tip design improves access into torturous vessels.

Business Wire 06.27.19

PREVENA Therapy Becomes FDA-Indicated to Help Reduce Superficial Surgical Site Infections

Clinical evidence supports PREVENA Therapy effectiveness in reducing SSIs in a range of medical specialties.

Business Wire 06.26.19

Neurological

BrainScope Appoints New CEO

Susan Hertzberg most recently served as CEO of Prelude Fertility, a comprehensive fertility services company.

Business Wire 06.25.19

ClearDATA Joins the Healthcare and Public Health Sector Coordinating Council

ClearDATA executives serving on HSCC task forces to address security in medical devices and cybersecurity best practices.

Business Wire 06.25.19

Cardiovascular

BioTrace Medical’s Tempo Lead Obtains CE Mark for Safe, Secure Temporary Intracardiac Pacing

New TAVR standard of care has been used in more than 3,000 procedures.

Business Wire 06.25.19

Cytek Biosciences Debuts Advanced Five-Laser Flow Cytometer

The Aurora system is now available with five lasers to enable seeing more than 30 colors from a single sample.

Globe Newswire 06.19.19

Imperative Care Receives FDA Clearance of the ZOOM Aspiration System

Product is used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease.

Business Wire 06.13.19

Study Shows Improved Phototherapy Treatment Adherence Using Clarify Home Light Therapy System

Results demonstrate more than 20 percent adherence improvement over legacy phototherapy technology.

Business WIre 06.10.19

Diagnostics

Samsung Demonstrates Viability of Lower Dose Digital Radiography Algorithm for Pediatric Patients

Offering greater diagnostic confidence with up to 45 percent dose reduction to improve pediatric patient care with S-Vue 3.02.

Business Wire 06.10.19

New MDR and IVDR Tools Released to Help Medical Device, Diagnostics Firms Comply With EU Regulations

SmartMDR and SmartIVDR offerings can help medtech organizations assess compliance, estimate costs, and prioritize remediation activities.

Business Wire 06.06.19

Elucent Medical Receives FDA Clearance for Breast Tumor Removal System

EnVisio Surgical Navigation System and SmartClip Soft Tissue Marker provide alternative for painful and costly localization procedures.

Business Wire 05.31.19

Fist Assist Devices Announces Approval of FACT by University of Chicago Medical Center

Intermittent Compression Device clinical trial aims to prove vein dilation to improve fistula outcomes in patients with Stage 4 kidney disease.

Business Wire 05.29.19

Cardiovascular

Foldax Inc. Gains Approval to Begin U.S. Clinical Trials of First and Only Biopolymer Heart Valve

Product is designed to be a lifetime valve with hemodynamic performance and quality of life similar to natural human valves.

Business Wire 03.29.19

Charles River Laboratories is Acquiring Citoxlab

Deal is expected to further strengthen Charles River’s position as a major early-stage contract research organization.

Business Wire 03.28.19

Natus Medical Refreshes its Board With Two New Independent Directors

Five of the company's seven independent directors have joined the board in the past three years.

Globe Newswire 03.27.19

Diagnostics

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