Medical Product Outsourcing

Diagnostics

Roche's Elecsys Anti-SARS-CoV-2 S Antibody Test Earns EUA

Detects antibodies against the SARS-CoV-2 spike protein.

GlobeNewswire 12.02.20

Diagnostics

FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test

First FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests.

GlobeNewswire 09.16.20

Diagnostics

Roche Earns EUA for SARS-CoV-2 & Influenza A/B Combo Test

Detects and differentiates SARS-CoV-2, influenza A virus, and/or influenza B virus with a single sample.

Roche 09.04.20

Diagnostics

FDA Approves Roche's HIV-1/HIV-2 Combo Test

Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test.

Roche 09.01.20

Diagnostics

Roche Nabs FDA Authorization for First Epstein-Barr Virus Quantitative Test

Virus's DNA levels are associated with a range of life-threatening diseases, including cancer in transplant patients.

Roche 08.07.20

Diagnostics

Roche Acquires Nanopore Sequencing Developer Stratos Genomics

Investment complements the development of Roche’s nanopore technology.

Roche 05.22.20

Diagnostics

Roche's COVID-19 Antibody Test Now Available at U.S. Lab Sites

LabCorp and more than 20 other commercial and hospital labs will be able to perform over 2 million tests per week by June.

PR Newswire 05.20.20

Diagnostics

FDA Grants EUA to Roche's COVID-19 Antibody Test

The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation).

Roche 05.04.20

Diagnostics

BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test

Adds automated extraction methods and additional PCR systems.

PR Newswire 04.27.20

Diagnostics

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

cobas 6800/8800 Systems deliver full automation.

Roche 04.21.20

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

Medtech Execs Named to White House Economic Task Force

Will provide recommendations on how best to safely reopen U.S. economy in the wake of the COVID-19 pandemic.

AdvaMed 04.15.20

Diagnostics

COVID-19 Test Availability Rapidly Scales Up

The industry rallies to boost production.

AdvaMed 04.01.20

Diagnostics

UC San Diego Partners with 5 Dx Manufacturers to Boost COVID-19 Testing

The University is working with Thermo Fisher, Roche, GenMark, Luminex, and Abbott.

University of California - San Diego 03.23.20

Diagnostics

Diagnostics Manufacturers Ramp Up COVID-19 Tests

By April, production will more than double.

AdvaMed 03.20.20

Diagnostics

FDA Authorizes Roche’s cobas SARS-CoV-2 Test

The CE-IVD test is also available in markets accepting the CE mark.

GlobeNewswire 03.13.20

Diagnostics

Global In-Vitro Diagnostics Industry Forecasted to Grow

New report estimates the industry will expand with a CAGR of 5.8% from 2020 to 2027.

PR Newswire 03.02.20

Diagnostics

Roche and Illumina to Expand Access to Genomic Testing

Combines Illumina’s decentralized installed base with Roche’s assay development to provide broad access to clinical oncology next-generation sequencing.

GlobeNewswire 01.14.20

Patient Monitoring | Software & IT

Roche's Blood Glucose Reading Smartphone App Gains CE Mark

The app determines blood glucose ranges by taking photos with the smartphone camera without the need for a blood glucose meter.

GlobeNewswire 12.10.19

Diagnostics

FDA OKs Roche's Nasal Swab MRSA Test

The cobas vivoDx MRSA test can detect the bacteria in as little as five hours.

U.S. Food and Drug Administration 12.06.19

Diagnostics | Digital Health | Neurological | Software & IT

An App-solute Symphony of Digital Health Solutions

Thirteen entrepreneurs competed on the Medica Connected Healthcare Forum stage for cash prizes.

Online Exclusives Sam Brusco, Associate Editor 11.20.19

RenovaCare Appoints President and CEO

Alan Rubino will lead the company.

RenovaCare Inc. 11.19.19

Diagnostics

From Genome Sequencing to the World’s First Portable MRI

Dr. Jonathan Rothberg has risen about as high as a scientist can, save for the Nobel Prize.

Sam Brusco, Associate Editor 11.04.19

Materials | Surgical

Double-Sided Tape for Tissues Could Replace Surgical Sutures

New adhesive that binds wet surfaces within seconds could be used to heal wounds or implant medical devices.

Videos Anne Trafton, MIT News Office

Petrochemical Company Executive Joins Invacare Board of Directors

New member has more than 30 years of experience in the manufacturing, industrial and consumer industries.

Business Wire 10.31.19

Roche Diagnostics Appoints New CEO

Mathew Sause joins Roche from Gilead Sciences.

Roche 10.29.19

Smith+Nephew Announces Change of CEO

Former CEO of Roche Diagnostics takes over.

Smith+Nephew 10.21.19

Neurological | Patient Monitoring

Xavant Technology Unveils Dual-Sensor Neuromuscular Patient Monitor

Features both AMG and EMG modalities in one portable system.

PRNewswire 10.15.19

New Solutions Presented at Medica Connected Healthcare Forum

Internet of Medical Things, care robots, pain therapy, and more.

Messe Düsseldorf North America 10.10.19

Diagnostics

FDA OKs cobas Babesia, Roche's First Whole Blood Test for Donor Screening

If undetected, Babesia infection can be fatal in patients receiving blood transfusions from infected donors.

GlobeNewswire 09.20.19

Pittsburgh Companies Partner on Life Science Clinical Development

Firms to address combo drug or device with digital health, digital therapeutics, blockchain, and software as a medical device platform in clinical development.

Business Wire 09.16.19

Tiny Soft Robotic Device Manages Immune Response to Implants

Discovery could enable longer-lasting and better-functioning devices including pacemakers, breast implants, biosensors, and drug delivery devices.

Institute for Medical Engineering and Science 09.06.19

Diagnostics

The Quest for Simplicity and Connectivity

Roche Diagnostics is focused on making life easier for hospital point-of-care coordinators.

Online Exclusives Michael Barbella, Managing Editor 08.14.19

Software & IT

Five Strategies to Navigate Regulatory Challenges in Medical Device Development

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Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19

3. GE Healthcare

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07.30.19

Software & IT

MEDICA App Competition 2019 Begins

MEDICA remains the hotspot for start-ups in the health sector.

MEDICA 07.08.19

Diagnostics | Neurological

Roche & Lund University Partner on Alzheimer's Blood Test

The method studied by the researchers was developed by Roche and is a fully automated technique which measures beta-amyloid in the blood.

Lund University 06.25.19

Diagnostics

A Home Blood Test to Better Monitor Chronic Illnesses

The first goal is to get the biosensor to detect three biomarkers—urea, potassium, and creatinine—in a drop of blood.

Universite de Montreal 05.28.19

Diagnostics

FDA Clears Roche to Expand Testing Menu on cobas 6800/8800 Systems for STDs

Addition of the cobas TV/MG test to the testing menu provides the flexibility to process up to four sexually transmitted infections from one patient sample.

PR Newswire 05.24.19