Medical Product Outsourcing

Digital Health

FDA OKs First AI-Enabled Device for Colon Cancer Detection

Product is composed of hardware and software designed to highlight portions of the colon where the device detects a potential lesion.

Michael Barbella, Managing Editor 06.01.21

Diagnostics

CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit

Allows BD MAX System users more flexibility with three alternatives for specimen collection.

Charles Sternberg, Assistant Editor 04.27.21

Ava Begins Evaluation of its Fertility Tracking Sensor Bracelet in COVID-19 Detection

Pilot study data shows Ava's algorithm accurately detected 71 percent of COVID-19 positive infections two days before symptom onset.

Michael Barbella, Managing Editor 04.27.21

Positive Study Results Touted for Forest Devices' Stroke Detection Technology

Company's diagnostic platform was up to 40 percent better at correctly identifying patients with large vessel occlusive strokes.

Michael Barbella, Managing Editor 03.16.21

Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection

The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.

Michael Barbella, Managing Editor 01.22.21

Diagnostics | Software & IT

FDA OKs Hologic's Genius AI Breast Cancer Detection Software

New deep-learning algorithm helps radiologists detect breast cancers in their early stages.

Business Wire 12.01.20

Diagnostics

GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit Wins EUA

Only EUA authorized virus-free testing assay that detects neutralizing antibodies within an hour.

PR Newswire 11.09.20

physIQ, Purdue University Studying Feasibility of COVID-19 Detection Through Smartwatch Data

Data from the study will inform new algorithms to be developed by physIQ, a Purdue-affiliated digital health technology company.

Business Wire 11.09.20

Chronic Disease

Exact Sciences to Acquire Thrive Earlier Detection

Announces plans to buy the rival company for $2.15 billion.

Exact Sciences 10.27.20

Diagnostics

Examining the COVID-19 Detection Kits Market

RT-PCR has become second to none in the global healthcare systems for testing COVID-19.

Online Exclusives Sunil Jha, Research Content Developer, Global Market Insights 10.16.20

Cardiovascular

Eko Awarded $2.7 Million Grant for Clinical Study on Valvular Heart Disease Detection

Ongoing research with Northwestern Medicine to validate algorithms and help more accurately screen for heart murmurs and valvular heart disease.

Business Wire 09.18.20

Diagnostics

Newsight’s Rapid COVID-19 Detection Test Shows Promise in Clinical Trial

Achieves a 95% success rate under laboratory conditions at Sheba Medical Center.

Sheba Medical Center 08.13.20

Electronics

Holst Centre Constructs New Near-Infrared Vein Detection Sensor

Takes biometric security to a new level; could eventually enable non-invasive in-body medical imaging.

Holst Centre 07.15.20

DermTech Announces Telemedicine Solution for its Melanoma Detection Test

The DermTech PLA uses a revolutionary adhesive patch technology to collect skin cells from the surface of an entire lesion without a biopsy.

Business Wire 07.02.20

Former Cepheid CEO Joins Sense Biodetection Board

Industry leader has more than 50 years of experience in diagnostics.

Sense Biodetection Ltd. 06.15.20

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 | Digital Health

Chip for Biomolecule Detection May Help in COVID-19 Testing

Purdue University's technique involves machine learning to train the system to detect certain features associated with particular diseases and viruses.

Purdue University 05.22.20

Cardiovascular | Diagnostics | Software & IT

Eko's ECG-Based Algorithm Gains EUA to Boost Heart Failure Detection

Can assist in identifying patients with abnormal heart function during the COVID-19 pandemic.

Business Wire 05.13.20

University's Paper Device Could Provide Portable Coronavirus Detection

Developing a process to manufacture the device, however, would cost at least several million dollars.

Purdue University 05.08.20

Diagnostics

Vela Diagnostics' COVID-19 Detection Test Earns CE Mark

Vela Diagnostics has also developed an automated version of the test slated for CE-IVD registration this month.

PR Newswire 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

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

Diagnostics

Enzo Biochem Launches COVID-19 Diagnostic Test

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

Business Wire 04.23.20

Diagnostics

FDA OKs Seegene's Allplex 2019-nCoV Assay

Seegene's technology has played a pivotal role in South Korea's rapid response to the COVID 19 outbreak.

PR Newswire 04.22.20

EarlySense Names New Senior Vice President of Strategic Partnerships

Former Cerner and Allscripts executive joins company to deepen existing relationships and broaden new global opportunities.

EarlySense 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 OKs Fosun Pharma's COVID-19 RT-PCR Detection Kit

Can complete detection of 96 samples within two hours.

PR Newswire 04.20.20

Diagnostics

Gold Standard Diagnostics Releases Three COVID-19 Antibody Tests

The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories.

Business Wire 04.17.20

Diagnostics

Sense Biodetection Accelerates Instrument-Free COVID-19 Diagnostic Test

Scale-up with Phillips-Medisize is underway to ensure timely delivery and distribution.

Sense Biodetection Limited 04.17.20

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

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

Digital Health

Viz.ai Adds Next-Generation Functionality to Artificial Intelligence Stroke Platform

New capabilities allow the stroke care team to synchronize care from stroke code notification to the post-acute care period.

Business Wire 04.16.20

Diagnostics

Abbott Launches COVID-19 Antibody Blood Test

Abbott begins shipping April 16 and intends to distribute 4 million tests in April.

PR Newswire 04.15.20

Diagnostics

BD Gains Second EUA for CE-Marked Molecular Diagnostic Test

New test uses BD Max System to augment supply from existing collaborations; test results in under three hours.

BD 04.13.20

Device Measures QT Segments in COVID-19 Patients Using Hydroxychloroquine

BardyDx’s CAM Patch will be used at hospitals across the Seattle area to monitor cardiac rhythms for COVID-19 patients on HCQ.

Bardy Diagnostics Inc. 04.09.20

Machining & Laser Processing

New Methods 5-Axis Bridge-Type Machining Center Offers High Performance

Machine can perform full five-axis precision machining of challenging parts, significantly reducing the need for multiple setups.

Methods Machine Tools 04.09.20

Diagnostics

FDA OKs Bio-Rad's Assay to Spot COVID-19 Antibodies

Initial data collected on more than 700 samples has demonstrated specificity above 99 percent.

Business Wire 04.07.20

CloudCath Announces $12 Million Series A Financing

Funds will be used to advance commercialization of technology enabling remote, real-time complication monitoring for at-home dialysis.

Business Wire 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

Diagnostics

FDA OKs Luminex's ARIES SARS-CoV-2 Assay

The system is capable of running up to 144 tests per day, requiring no specialty training.

PR Newswire 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

BD, BioGX’s COVID-19 Diagnostic Approved for Use in U.S.

Emergency use authorization helps make the test available quickly and efficiently.

BD 04.03.20

Circadia Health Commits $3 Million in Respiratory Monitors to Combat COVID-19

Effort is in response to FDA’s latest guidance to expand the availability and capability of non-invasive remote respiratory monitoring devices.

Globe Newswire 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

Diagnostics

PCR Biosystems Works to Ensure Availability of COVID-19 Test Reagents

Company has the capacity to manufacture enough reagent daily for 4 million reactions, which is sufficient for millions of diagnostic tests.

PCR Biosystems 04.02.20

Digital Health

Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

Michael Barbella, Managing Editor 04.01.20

Diagnostics