Medical Product Outsourcing

Diagnostics

Quidel, Beckman Coulter End Ongoing BNP Business Litigation

Quidel to receive cash payments between $70 million to $75 million per year through 2029.

Business Wire 07.26.21

Diagnostics

Global PCR Tech Market to Hit $11.04 Billion by 2027

But high manufacturing costs and prolonged time period for test results will continue to negatively impact the sector.

Globe Newswire 07.26.21

Diagnostics

BurstIQ and FlowMetric Life Sciences Launch Novel Vaccine Immune Response Test

The VaxEffect platform empowers both patients and providers to make more informed health decisions.

07.23.21

Diagnostics

Nova POC Creatinine/eGFR Method More Accurate Than Lab Method

One of the first studies to compare the accuracy of POC creatinine/eGFR devices to iohexol mGFR method yields promising results.

Nova Biomedical 07.20.21

Diagnostics

Owlstone Medical Launches Breath Testing for Digestive Health

Testing enables patients to take better control over their digestive health through a simple at-home breath test.

Owlstone Medical 07.19.21

Diagnostics

NanoDx Inc. Enters Licensing Agreement with IBM Research

Collaboration aims to enhance and expand accurate, rapid testing for several indications, including COVID-19, Traumatic Brain Injury, Sepsis and Stroke.

NanoDx Inc. 07.15.21

Diagnostics

Hologic Gains CE Mark for Saliva Samples with COVID-19 Test

Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.

Business Wire 07.14.21

Diagnostics

Lumos Diagnostics Appoints Three Industry Leaders as Independent Directors

Trio brings strong knowledge of equity markets and broad corporate governance expertise to the firm.

Business Wire 07.09.21

Diagnostics

Alere to Pay $39M to Resolve False Claims Suit

Allegedly sold diagnostic devices they knew had a materially defective algorithm.

U.S. Department of Justice 07.09.21

Diagnostics

FDA OKs Siemens Healthineers' MAGNETOM Free.Max MR Scanner

Company’s smallest, most lightweight scanner uses less than 1 liter of helium and no quench pipe.

Business Wire 07.06.21

Digital Health

EXINI Diagnostics Receives CE Mark Clearance for aPROMISE

The technology allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen.

Business Wire 07.02.21

Diagnostics

Global POC Diagnostic, Testing Market to Top $34B by 2027

The advent of advanced technologies, a growing geriatric population, and the rising prevalence of infectious as well as chronic diseases will help drive growth.

Globe Newswire 07.01.21

Solid Growth Anticipated for Global Sleep Apnea Diagnostics Market

Sector is expected to swell nearly 7 percent annually through 2027.

Globe Newswire 07.01.21

Diagnostics

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

Leveraging technology to improve speed to market without sacrificing quality.

Online Exclusives Brandon Henning, VP of Product at Greenlight Guru 07.01.21

Diagnostics

Face Mask Prototype Can Spot COVID-19 Infection

Sensor tech could also create clothing that detects a variety of pathogens and other threats.

Anne Trafton, MIT News Office 06.30.21

Cardiovascular | Diagnostics

Philips, CNIC Partner on New Ultra-Fast Cardiac MRI Protocol

Technique can be implemented on existing MRI scanners.

Philips 06.30.21

Diagnostics

Interventional Systems’ Miniature Medical Robot Cleared by FDA

Makes way for the European company to start building its U.S. presence.

Interventional Systems 06.29.21

Diagnostics

PixCell's Rapid Blood Test Diagnostics

MPO's Sean Fenske speaks with Hanan Ben-Asher of PixCell Medical about the opportunities enabled with rapid blood diagnostics.

Sean Fenske, Editor-in-Chief 06.29.21

Diagnostics

Abbott's Panbio Rapid COVID-19 Antigen Self-Test Earns EU Approval

Approved for sale directly to consumers and for use in adults and children with or without symptoms.

Abbott Laboratories 06.28.21

Diagnostics

DARPA Enlists University to Develop AI for Portable Ultrasound

Research team will put expert knowledge at the fingertips of frontline medics.

Carnegie Mellon University 06.22.21

Diagnostics

FDA Breakthrough Device Designation Granted for OCT Imaging System

Designation provides potential pathway to expedite adoption of transformative medical imaging technology combined with AI.

Business Wire 06.09.21

Diagnostics | Neurological | Software & IT

FDA OKs Autism Spectrum Disorder Diagnostic Aid

Cognoa ASD Diagnosis Aid uses a machine learning algorithm to evaluate patients at risk of ASD.

Sam Brusco, Associate Editor 06.03.21

Diagnostics

Widening Scope: An Endoscopy Device Report

Minimally invasive surgical techniques and AI are spawning advancements in endoscope design and function.

Michael Barbella, Managing Editor 06.02.21

Diagnostics

A One-Second Saliva-Based COVID Test

Researchers have built a microfluidic device capable of detecting the SARS-CoV-2 spike protein in a saliva sample within an astonishing one second.

Sam Brusco, Associate Editor 06.02.21

Diagnostics

BD Launches Urine Culture Application

Helps accelerate workflow and drive lab efficiency.

Charles Sternberg, Assistant Editor 06.01.21

Diagnostics

Boston Scientific Receives CE Mark for Single-Use Bronchoscope

The EXALT Model B Bronchoscope is the latest device in the company’s single-use imaging portfolio.

Charles Sternberg, Assistant Editor 05.28.21

Diagnostics

Heru Inc. Closes $30 Million Series A Financing

Advances its cloud and AI-enabled wearable vision diagnosis and therapy.

Charles Sternberg, Assistant Editor 05.20.21

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

Diagnostics

New Findings Could Help Improve Pregnancy Outcomes

Researchers have developed a model for studying uterine fluid in the lab without the need for invasive monitoring or experimentation on active pregnancies.

Charles Sternberg, Assistant Editor 05.14.21

Diagnostics

Researchers Develop AI to Predict Outcomes for Patients with Diseased Dental Implants

The team was surprised by the types of cells associated with better outcomes for implant patients.

Charles Sternberg, Assistant Editor 05.13.21

Diagnostics

Olympus Releases New Endobronchial Ultrasound Bronchoscope

The BF-UC190F aids physicians in diagnosing and staging lung cancer without surgery.

Sam Brusco, Associate Editor 05.12.21

Diagnostics

MatMaCorp Launches Handheld Molecular Diagnostics Tool

Product is capable of simultaneous PCR amplification and real-time fluorescent detection, with cycle threshold values, in under an hour.

Michael Barbella, Managing Editor 05.11.21

Diagnostics

Medtronic’s Pillcam and GI Genius—A Medtech Matters Podcast

MPO's Sean Fenske speaks with Giovanni Di Napoli of Medtronic about the company’s diagnostic technologies they are offering for the gastrointestinal space.

Sean Fenske, Editor-in-Chief 05.11.21

Diagnostics

RSIP Vision Launches Prostate MRI-to-Ultrasound Registration Tool

Module creates a warped MRI scan that matches real-time ultrasound results to precisely locate clinically relevant regions & reduce procedural risks to patients

Charles Sternberg, Assistant Editor 05.07.21

Diagnostics

Medivolve & Marvel Diagnostics Complete First Stage Clinical Testing of BlowFISH

The technology has entered the next phase toward applying for an EUA from the FDA to test for the COVID-19 virus.

Charles Sternberg, Assistant Editor 05.06.21

Chronic Disease | Diagnostics

GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.

Sam Brusco, Associate Editor 05.06.21

Diagnostics

COVID Diagnostics from Beckman Coulter—A Medtech Matters Podcast

MPO's Sean Fenske speaks with Chris Hagen of Beckman Coulter about the company’s response to the need for COVID diagnostics and the rapid ramp-up of production.

Sean Fenske, Editor-in-Chief 05.04.21

Diagnostics