Medical Product Outsourcing

Diagnostics

BD Announces CE Marked Assay for HPV Screening from At-Home Self-Collected Samples

Affords women greater access to testing.

Charles Sternberg, Assistant Editor 05.14.21

Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry

Prevalence of critical congenital heart disease in the Sri Lankan study was 2.02 per 1,000 live births.

Michael Barbella, Managing Editor 04.22.21

Diagnostics

BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.

Sam Brusco, Associate Editor 04.01.21

Diagnostics

FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device

Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.

Sam Brusco, Associate Editor 03.23.21

Diagnostics

Study Validates Vocalis Health’s COVID-19 Screening Tool

VocalisCheck obtains CE mark approval for medical use.

Charles Sternberg, Assistant Editor 02.18.21

Rapid Screening App Uses Wearable Sensor Data to Detect COVID-19 Infection

New screening tool proves almost twice as effective as temperature checks in predicting coronavirus.

NeuTigers 01.13.21

Diagnostics

RSIP Vision Announces New Cardiac Diagnostic Tool for PoC Ultrasound Screening

New algorithmic module provides an automated expert-level assessment of heart function for point of care medical teams.

RSIP Vision 12.16.20

First National Pediatric Cardiac Screening Database is Established

FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening.

Business Wire 11.30.20

Chronic Disease | Diagnostics | Software & IT

Eyenuk's Autonomous AI for Diabetic Retinopathy Screening Wins FDA Nod

First FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.

Business Wire 08.07.20

Study: 3D Face Photos Could be a Sleep Apnea Screening Tool

Researchers see bright future for 3D photography as a screening tool, potentially combined with data from a patient’s digital health tracker and health history.

American Academy of Sleep Medicine 06.22.20

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

BIOTECON Launches SARS-CoV-2 Screening and Identification Kits

The assays are based on the WHO reference methods.

PR Newswire 04.28.20

R&D & Design

Medtech R&D Must Address Outcomes in Value-Based Care

Clinical requirements are no longer the only cornerstone of medical device development.

Online Exclusives Michael Barbella, Managing Editor 04.24.20

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

Diagnostics

Enzo Biochem Launches COVID-19 Diagnostic Test

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

Business Wire 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

Non-Traditional Thinking Can Help Drive Medtech R&D

Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.

Online Exclusives Michael Barbella, Managing Editor 04.21.20

Diagnostics

FDA Approves HPV Test for Roche's cobas 6800/8800 Systems

cobas 6800/8800 Systems deliver full automation.

Roche 04.21.20

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

R&D & Design

Smaller Businesses Beget Better Innovation

Despite their global sales reach, large firms tend to focus on nurturing existing product lineups.

Online Exclusives Michael Barbella, Managing Editor 04.16.20

Diagnostics

OraSure Wins BARDA Funding for Rapid Oral In-Home COVID-19 Test

Would help alleviate the pressure on over-burdened healthcare systems.

GlobeNewswire 04.06.20

Diagnostics

Researchers Validate Viability of Saliva in COVID-19 Detection

Saliva testing allows for simple self-administered sample collection that even those in quarantine or self-isolation can use.

Spectrum Solutions LLC 04.03.20

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

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

COVID-19’s Impact on the Medical Device Supply Chain

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Tony Freeman, President, A.S. Freeman Advisors LLC 04.01.20

Patient Monitoring

Philips Enables Hospitals, GPs to Remotely Screen, Monitor COVID-19 Patients

Telehealth solution processes high volume coronavirus-related healthcare requests via online screening.

GlobeNewswire 04.01.20

Diagnostics

Cue Health Awarded $13 Million for Rapid, Portable COVID-19 Test

Company's diagnostic can detect virus in less than 25 minutes using a nasal swab.

Globe Newswire 03.31.20

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

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

9 Ways AI Will Disrupt Healthcare in the Next 5 Years

The technology could impact areas from stroke detection to mental health to access to specialized care.

Online Exclusives Scott Molina, IT Consultant 03.26.20

Diagnostics

Hardy Diagnostics Releases Rapid Test for COVID-19

Partnership with Autobio Diagnostics enables company to become a U.S. supplier of one-step lateral flow assay that detects both IgG and IgM antibodies.

Newswire 03.25.20

Diagnostics

FDA OKs Mesa Biotech's 30 Minute POC COVID-19 Test

Palm-sized system will enable broader use across healthcare facilities closer to the patients.

PR Newswire 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

R&D & Design

Pediatric Medical Device Pitch Competition Announces 30 Semi-Finalists

Thirty innovators will compete on March 23, 2020 in a virtual showcase.

National Capital Consortium of Pediatric Device Innovators 03.19.20

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

FDA Suspends Foreign Inspections

The agency has postponed most foreign inspections through April, effective immediately.

Food and Drug Administration 03.10.20

Diagnostics

Coronavirus Test Developed for Hologic's Panther Fusion System

German laboratory-developed test uses Panther Open Access functionality.

Business Wire 03.05.20

Patient Monitoring

FDA Clears Masimo for Continuous RRp Monitoring

Both continuous and spot-check RRp are now available in the US.

Business Wire 03.02.20

Diagnostics

Study Compares 'Fast Breast MRIs' to 3D Mammograms in Detecting Cancers

Builds evidence for use of Fast MRI in women with dense breasts.

University Hospitals Cleveland Medical Center 03.02.20

Undiagnosed Obstructive Sleep Apnea in Seniors Leads to Other Health Issues

Study finds that those diagnosed with OSA seek more medical care and at a higher cost in the 12 months prior to their diagnosis.

American Academy of Sleep Medicine 02.28.20

FDA Offers Coronavirus Update Regarding Product Safety

The agency outlines the steps it will take to ensure the quality of foreign products.

U.S. Food and Drug Administration 02.25.20

Diagnostics

Anitoa Introduces Rapid, On-Site Test for Coronavirus

Patient samples like throat or nasal swaps can be applied directly to the portable instrument without the need to freeze, transport and thaw the samples.

PR Newswire 02.25.20

Diagnostics