Medical Product Outsourcing

The New U.K. Conformity Assessment: 10 Checklist Items

The transition to the U.K.’s new regulatory regime officially began as of the first of January 2021.

Ed Ball, Senior Associate, RQM+ 09.10.21

PainQx Awarded $1.5 Million Contract to Refine its Pain Assessment Tech

Defense contract will enable the firm to conduct a multi-site human research study, refine current algorithms, and develop additional pain-related algorithms.

Globe Newswire 08.25.21

Diagnostics

Hillrom Advances Its Physical Assessment Tools

Launches the Welch Allyn PanOptic Plus Ophthalmoscope and MacroView Plus Otoscope.

Charles Sternberg, Assistant Editor 04.29.21

India's NIPT Testing Market Driven by Demand for Non-Invasive Genetic Assessments

Not surprisingly, the market lost value last year due to COVID-19.

Michael Barbella, Managing Editor 01.29.21

Modulim Granted CE Mark for Clarifi Imaging System for Microvascular Assessment

Clarifi is the newest advancement for assessing tissue and microvascular function.

Business Wire 01.04.21

Diagnostics

FDA OKs Cognita Labs' PulmoScan Home-Usable Lung Assessment device

The first-of-its-kind lung assessment device measures airway resistance and elastance.

PR Newswire 10.28.20

Diagnostics

University Working on a Bulls-Eye Anemia Assessment

Smartphone app in development would detect condition via inner eyelid photo.

Purdue News Service 07.23.20

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

Study: Whole Breast Ultrasound Tomography Improves Breast Cancer Risk Assessment

Researchers compared mammography and whole breast ultrasound in younger women with dense breast tissue.

Business Wire 05.18.20

Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts

Tests will aid in responsible back-to-work assessment, according to manufacturer.

Ortho Clinical Diagnostics 04.27.20

Diagnostics

WytCote Introduces Three-Minute COVID-19 Antibody Test

The company has applied to the FDA for Emergency Use Authorization.

PR Newswire 04.24.20

Molding

Mack Molding, Health System Partner to Develop Face Mask Alternative

Within two weeks, the team fabricated an attachment to a snorkeling scuba mask.

Mack Molding 04.22.20

Diagnostics

GenoSensor's High-Throughput COVID-19 RT-PCR Diagnostic Granted FDA EUA

Provides test results in less than 90 minutes.

Business Wire 04.21.20

Diagnostics

FDA Update: COVID-19 Antibody Test Validation and Education

Results from these tests can help identify who has been infected and developed antibodies.

U.S. Food and Drug Administration 04.20.20

Study: UV Technology Raises Standard in Disinfecting ORs, Medical Equipment

Hospitals use established protocols for cleaning and disinfecting ORs and medical equipment with chemical wipes after each case.

Business Wire 04.20.20

Diagnostics

Mologic Launches New Lab-Based COVID-19 Antibody Tests

With manufacturing support from Omega Diagnostics, the laboratory-based test aims to deliver up to 46,000 results per day.

Mologic Ltd. 04.20.20

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

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

Software & IT

Remote Check Solution for Cochlear Implants Wins FDA Nod

Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever.

PR Newswire 04.07.20

Diagnostics

COVID-19 Patients Being Triaged, Assessed Using Two-Minute Breath-Based Gas Test

The MediPines AGM100's breathing gas-based measurement can provide immediate respiratory data after the patient breathes into a breathing tube.

PR Newswire 04.06.20

Adopted Proposal Would Delay MDR One Year

The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.

European Commission 04.03.20

Diagnostics

Siemens Healthineers Releases Test Kit for Coronavirus COVID-19

Test kit will help detect SARS-CoV-2, the cause of COVID-19; company is pursuing EUAs from WHO and FDA for clinical use.

Siemens Healthineers 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

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

R&D & Design

Supercharge Medical Device Innovation Using Effective User Preference Studies

User preference and evaluation studies have been a mainstay design tool for medical device development for decades.

Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 04.01.20

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

Philips to Assess PCI Outcomes Using Integrated iFR Technology

Global multi-center study will compare outcomes between physiological guidance by iFR data co-registered on the angiogram vs. angiogram alone.

Royal Philips 03.27.20

Patient Monitoring

Medtronic Launches New Solutions to Monitor COVID-19

Helps assess, monitor, and triage support for patients concerned about COVID-19 and respiratory symptoms.

GlobeNewswire 03.27.20

Digital Health

MyTelemedicine Rolls Out Rapid Response Virtual Care Platform

Healthcare providers can meet increased patient demand in the face of COVID-19 by using a cloud-based telehealth platform.

PR Newswire 03.26.20

Diagnostics

Mologic, Partners Begin Validation for COVID-19 Point-of-Need Diagnostic Test

Prototypes will be sent to labs in the United Kingdom, Senegal, Spain, China, Malaysia, and Brazil for priority validation.

Mologic Ltd. 03.26.20

Hillrom More than Doubles Critical Care Product Production

Includes ventilators, hospital beds, and vitals monitoring devices to support COVID-19 response.

PR Newswire 03.25.20

FDA Approves AEGEA Medical's Mara Water Vapor Ablation System

Reduces heavy menstrual bleeding, improves quality of life, and preserves long-term uterine cavity access.

Business Wire 03.24.20

Former FDA Reviewer Joins Syntactx as Regulatory Strategist

New hire spent more than 30 years working for the agency.

Business Wire 03.24.20

Digital Health

MobileSmith Health's Mobile Apps Support Hospital Response to COVID-19

Apps allow hospitals to share reliable, accurate information on the coronavirus pandemic with the community, hospital employees, and volunteers.

Globe Newswire 03.24.20

Diagnostics

COVID-19 Self-Assessment Tool Offered by MyTelemedicine

Leading telemedicine provider seeks to rapidly deploy consumer-friendly solutions to mitigate spread of deadly coronavirus.

PR Newswire 03.18.20

Lumos Diagnostics Secures $15 Million in Series A Funding

Money will help the company commercialize its rapid POC test and an FDA clinical trial.

Business Wire 03.17.20

Baxter, Spectral Medical Reach Agreement for Blood Filter Distribution

Deal enables Baxter to expand its Acute Therapies portfolio to address unmet needs, and gives Spectral Medical a strategic commercialization partner.

Business Wire 03.13.20

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

Testing

Testing in Flux: Changing Protocols for a Transformative Industry

As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners.

Mark Crawford, Contributing Writer 03.04.20

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