Abbott’s Fast Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization

ABBOTT PARK, Ill., Aug. 26, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.

Source: Abbott’s Fast, $5, 15-Minute, Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization; Mobile App Displays Test Results to Help Our Return to Daily Life; Ramping Production to 50 Million Tests a Month – Aug 26, 2020

Thermo Fisher’s COVID-19 Test Could Have Inaccurate Results

FDA warned earlier this week that Thermo Fisher Scientific’s TaqPath test could have a risk of false results. This follows the Waltham, MA-based company exiting its bid to acquire Qiagen for $12.5 billion.

Source: Thermo Fisher’s COVID-19 Test Could Have Inaccurate Results

Homodeus Awaits COVID Home Testing Approval

Many of us have seen and even felt what it’s like to have a test for COVID-19. One Connecticut medical science company saw the national struggle to make tests available, so they took on the challenge.

Source: Guilford Company Awaits COVID Home Testing Approval

COVID-19: FDA Opens Door for Rapid At-Home Testing

FDA opens door to rapid, at-home screening for COVID-19

The Food and Drug Administration on Wednesday opened the door to COVID-19 testing that could be fast, cheap, and handled entirely at home — if companies don’t find the rules too burdensome.

Source: FDA opens door to rapid, at-home screening for COVID-19

Abbott’s COVID-19 tests did the heavy lifting in Q2

Abbott’s second-quarter earnings showed a mixed bag with pandemic disruptions on the medical device side of the business, and sales of COVID-19 tests driving growth for the diagnostic side.

Source: Abbott’s COVID-19 tests did the heavy lifting in Q2

A Medical Aesthetic Device Case Study: Candela

Candela is driven by an unwavering focus on quality and innovation. For more than 50 years, the company has pioneered breakthroughs using energy-based laser devices for treating a broad range of conditions, from hair removal and wrinkle reduction to traumatic scarring involving wounded warriors and burn victims.

Source: A Medical Aesthetic Device Case Study: Candela | Jabil

How Speed Up the Healthcare Product Development Cycle 

Healthcare worldwide is at an exciting inflection point. On the one hand is reactive medicine, which to a large extent describes the profile of the existing system – you get sick, visit your healthcare provider, get treated and go home.

Source: 3 Ways to Speed Up the Healthcare Product Development Cycle | Jabil