Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]
Abbott: ID NOW COVID-19 results more accurate with earlier testing
Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]
5 companies on the front lines of the coronavirus fight
Nancy Crotti, Managing Editor and Danielle Kirsh, Senior Editor Amid the stock market roller-coaster ride that began last month, medtech companies that make devices and diagnostic tests vital to fighting COVID-19 may ultimately fare better than others, but it’s hard to tell until the virus peaks and people get back to work. At midafternoon today, […]
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
NuvoAir inks deal with Roche Italy for cystic fibrosis care
NuvoAir announced that Roche Italy will distribute its digital respiratory technology to certain cystic fibrosis (CF) centers across Italy. NuvoAir’s respiratory platform is designed to allow patients to assess lung function in their own homes and respond to specific symptom questionnaires. The data collected by the platform helps the patient understand their progress and can […]
Roche wins CE Mark for blood glucose reading smartphone app
Roche (SWX: RO, ROG) today announced that it has obtained a CE Mark for its Accu-Chek SugarView app, which allows a person to read a blood glucose test strip without a meter. The smartphone app, which will be first available on certain phone models via the Google Play Store, instead uses the phone’s camera to […]
FDA names Flatiron Health’s Abernethy as deputy commish | Personnel Moves, December 19, 2018
The FDA this week named Amy Abernethy, the chief medical officer for Roche subsidiary Flatiron Health, as principal deputy commissioner to replace Rachel Sherman, who is retiring in January. “She’s a highly regarded thought leader who has held numerous positions of leadership in her fields of interest and distinguished herself for her intellect, her passion […]
Genentech touts data for refillable eye implant in wet-AMD trial
Roche‘s (OTC:RHHBY) Genentech touted additional positive data last week from a Phase II study of its Port Delivery System, a refillable eye implant designed to deliver ranibizumab to treat wet age-related macular degeneration. The company first reported top-line results from the Phase II Ladder study in July. The implant is intended to allow wet-AMD patients to go for months […]
Genentech kicks off Phase III trials for eye implant
Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched three Phase III trials evaluating the Port drug-delivery implant in patients with wet age-related macular degeneration and diabetic macular edema. The device is a refillable eye implant designed to continuously release drugs over a period of several months. Get the full story at our sister site, Drug […]
Genentech touts positive data for tiny, refillable eye implant
Roche‘s (OTC:RHHBY) Genentech touted positive top-line data today from a Phase II study of its Port Delivery System, an eye implant designed to administer a sustained dose of ranibizumab in patients with wet age-related macular degeneration. The refillable device, which is slightly longer than a grain of rice, is intended to enable wet-AMD patients to go for […]
Roche wins CE Mark for Accu-Chek Solo insulin micropump
Roche (OTC:RHHBY) said today that it won CE Mark clearance for its Accu-Chek Solo insulin micropump system. The company plans to launch a pilot commercialization phase for its device in the coming weeks in Austria, Poland, Switzerland and the U.K. Get the full story at our sister site, Drug Delivery Business News.
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