Olympus today said it launched its Evis X1 endoscopy system. Evis X1 is designed to improve outcomes from disorders of the stomach, colon and esophagus as well as various bronchial diseases. It features easy-to-use technologies to support how gastrointestinal disorders like colorectal cancer (CRC) are detected, characterized and treated. The system features extended depth of […]
Diagnostics
AdvaMed says 25m COVID-19 tests in the pipeline
Diagnostic testing companies are aiming to deliver 25 million COVID-19 tests by the end of April and increase that number by the end of May, the head of medtech trade group AdvaMed said today. But the number of available tests is less important than the U.S. healthcare system’s capacity to process all the tests that […]
Mayo Clinic COVID-19 test receives EUA
FDA announced this week that it’s granted an emergency use authorization for Mayo Clinic’s real-time polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19. The Rochester, Minn.–based health provider is already running thousands of coronavirus tests daily — with help from diagnostic processors from Roche Diagnostics, that run the Roche Cobas SARS-CoV-2 test. […]
Abbott COVID-19 test machine’s capacity questioned again
High-level questions about the performance of an Abbott (NYSE:ABT) device used to test samples for COVID-19 arose again yesterday. During Monday’s White House coronavirus briefing, Vice President Mike Pence said there is enough testing capacity within the country to begin phase one of President Donald Trump’s plan to reopen the economy — a notion that some […]
BREAKING: LabCorp at-home COVID-19 test gets FDA EUA nod
The FDA announced today that it granted emergency use authorization (EUA) for an at-home COVID-19 diagnostic test from Laboratory Corporation of America (NYSE:LH). LabCorp received EUA for its COVID-19 RT-PCR test last month, saying at the time that it would rapidly expand its testing capabilities with the expectation of more than 20,000 tests performed per […]
DeviceTalks Weekly: Ep.6 – Hear about the Coventor ventilator, COVID-19, Q1 earnings and MassDevice’s Medtech 100 Index
In this week’s episode of DeviceTalks Weekly, Aaron Tucker of the Earl Bakken Medical Center shares the origin of the recently approved Coventor ventilator, which will be manufactured at-cost by Boston Scientific. We’ll also hear comments Abbott CEO Robert Ford made during the company’s Q1 analyst call as the MassDevice team begins to dissect how […]
FDA approves Q-tip-like swabs to allow patient self-testing for COVID-19
The FDA announced today that spun synthetic swabs — with a design similar to Q-tips — could be used to collect samples from patients suspected of having COVID-19. Patients could even take the samples themselves from the front of the nose, the agency said. The solution could help solve multiple problems: The nationwide shortage of […]
Theranos founder Elizabeth Holmes’ trial date pushed back amid coronavirus
Ex-Theranos CEO Elizabeth Holmes will see her federal court trial over fraud charges start on Oct. 27, instead of July 28, amid coronavirus pandemic worries — as well as prosecutors’ desire to add more charges against her. “We’re in unchartered waters and unchartered territories,” U.S. District Judge Edward Davila said yesterday during a trial status […]
Abbott offering millions of lab-based COVID-19 antibody tests
Abbott (NYSE:ABT) said today that it has launched its third test for COVID-19 — and this time it’s an antibody test. Antibody tests for coronavirus are an important weapon in the fight against the pandemic because they can also tell whether someone has had the virus in the past. Such information is crucial to evaluate how […]
BD wins EUA, CE Mark for COVID-19 test that can return results in hours
Becton Dickinson (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) and CE Mark approval for a new COVID-19 molecular diagnostic test. The test, based on the U.S. Centers for Disease Control assay design and run on the BD Max system, may return results in 2-3 hours, according to the Franklin Lakes, N.J.-based company. […]
FDA approves first saliva-based coronavirus test
The FDA granted emergency use authorization (EUA) to Rutgers University’s RUCDR Infinite Biologics and its collaborators for an approach using saliva as test biomaterial for COVID-19. In tandem with Spectrum Solutions and Accurate Diagnostics Labs, RUCDR developed the saliva collection methods as an alternative to nose and throat swabs when testing for SARS-CoV-2, the virus […]