Medical Product Outsourcing

Shimmer Research Extends Wearable Sensing Platform for Clinical Trials

Verisense platform can now measure heart rate, oxygen saturation, and emotional responses in addition to overall activity and sleep levels.

Michael Barbella, Managing Editor 03.26.21

Digital Health

Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials

Medidata Detect identifies known and unknown risks, and triggers corrective actions.

Business Wire 10.05.20

ERT Continues to Drive Innovation in Virtualization for Respiratory Clinical Trials

Partnership with Inofab Health keeps respiratory trials on track and ensures patient safety during and after COVID-19.

ERT 08.26.20

ERT Survey Indicates Swift Adoption of Virtual Clinical Trials Due to COVID-19

More than eight of 10 respondents are implementing elements of virtual trials due to the pandemic.

ERT 08.03.20

Pivotal Providing Specialized Clinical Research Services for COVID-19 Clinical Trials

Study to discover whether hyperimmune plasma with virus antibodies will benefit patients with COVID-19 acute phase.

Targetwire.com 06.25.20

Patient-Administered ECG Assessment Enables Clinical Trials to Continue During Pandemic

Patients monitor cardiac safety at home with FDA-cleared KardiaMobile 6L personal ECG.

ERT 06.19.20

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.

Online Exclusives Sam Brusco, Associate Editor 06.09.20

Diagnostics

Enzo Biochem Launches COVID-19 Diagnostic Test

Proprietary molecular diagnostic kits offer improved scale, throughput, and sensitivity.

Business Wire 04.23.20

Endonovo Therapeutics Introduces Support of SofPulse With New Patient Brace

The brace allows site-specific application and promotes ease of use for patients and medical professionals when using the SofPulse device.

Globe Newswire 04.23.20

Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

The company says it is well positioned for recovery.

Globe Newswire 04.22.20

COVID-19 Trial Targets Patients With Underlying Medical Conditions

Trials are now waiting IRB approvals and are about to launch under existing contracts at multiple sites including top U.S. universities.

Circularity Healthcare 04.21.20

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

BEAT19 Crowdsourcing Study Jump Starts Data Collection for Coronavirus Research

Two hundred forty million Americans can play a vital role in the search for a vaccine or treatment by contributing critical data from home.

Globe Newswire 04.16.20

Non-Invasive Microcirculatory Device Could Help COVID-19 Patients

Product provides non-invasive, transdermal microcirculation to improve overall oxygen-rich blood flow and treat underlying medical conditions.

Circularity Healthcare LLC 04.14.20

monARC Bionetworks CEO Joins Glooko as Chief Operating Officer

Company also recruits LexisNexis Health Care executive for chief commercial officer job.

Glooko 04.07.20

PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables

Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.

PhysIQ 04.07.20

Surgical

Olympus' Non-Surgical BPH Device Wins FDA De Novo

The iTind flexible three-strut nitinol device can be placed during an in-office procedure.

Olympus 04.06.20

Diagnostics

COVID-19 At-Home Test Ready for Validation Study

Care Access Research will lead clinical trials of the coronavirus test.

Care Access Research 04.03.20

Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic

A reminder of what manufacturers should keep in mind during this turbulent time.

Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20

Diagnostics

Biomerica Working With N.Y. Medical School on COVID-19 Antibody Test

Once developed and scaled-up, the company’s existing production capacity could allow for more than 1 million tests per month.

Globe Newswire 04.02.20

R&D & Design

Why Outsourcing Is in: Piecing Out Projects Makes Sense

Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.

Dawn A. Lissy, President & Founder, Empirical 04.01.20

CORRECTION: Bodysphere's Two-Minute Serological Test Kit To Detect Novel Coronavirus

Company incorrectly indicated the test had acquired an Emergency Use Authorization from the FDA.

Sean Fenske, Editor-in-Chief 03.31.20

Cardiovascular

FDA Approves ZOLL's Next-Gen TherOx System for 'Widowmaker' Heart Attacks

SSO2 Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle.

Business Wire 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

Cardiovascular

Edwards Pauses Enrollments in Pivotal Mitral, Tricuspid Trials

Decision was made in response to hospitals' focus on COVID-19.

PR Newswire 03.30.20

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

Diagnostics

Biomerica Begins Shipping Samples of 10-Minute Test for COVID-19 Exposure

The test for coronavirus exposure uses blood from a finger prick and can be performed anywhere by trained professionals.

Globe Newswire 03.18.20

Endonovo Donating Devices to ICUs to Help Reduce COVID-19 Respiratory Inflammation

The Sofpulse product is going to hospitals with coronavirus patients in critical care.

Videos Globe Newswire

Surmodics Names New Vice President of Clinical Affairs

Former Edwards Lifesciences executive has more than 20 years of medical affairs, medtech, and healthcare experience.

Business Wire 03.13.20

Alcon Launches Vivity Presbyopia-Correcting IOL in Europe

Non-diffractive lens offers a continuous extended range of vision.

Business Wire 03.12.20

Brexit Deal Will Impact Medical Device Development in U.K.

More than 20,000 medical devices are currently in the pipeline globally, with almost half in the early stages of development.

GlobalData 03.12.20

Cardiovascular

Nanoparticle Chomps Away Plaques That Cause Heart Attacks

The particles deliver a drug agent that stimulates cells to engulf and eat cellular debris.

Michigan State University 03.10.20

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

FDA Approves Allergan's Durysta Glaucoma Implant

Lowers intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

PR Newswire 03.06.20

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