Visby Medical wins FDA EUA for respiratory health test

Visby Medical announced today that it received FDA emergency use authorization (EUA) for its Respiratory Health point-of-care test.

San Jose, California-based Visby designed its polymerase chain reaction (PCR) test for the fast detection of respiratory infections. Influenza (flu) A and B, as well as SARS-CoV-2 (COVID-19) can cause these upper respiratory infections. The PCR test differentiates between such cases.

The “instrument-free” platform fits in the palm of a user’s hand. Visby said it provides accurate results in under 30 minutes at the point of care. This enables clinicians to accurately and quickly diagnose and treat patients.

Visby said both the CDC and the Infectious Disease Society of America recommends the use of rapid molecular assays. The company said these improve detection for outpatients compared to rapid influenza diagnostic tests.

“Accurate, rapid, point-of-care testing can help physicians prescribe appr…

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The 24 best medical device innovations of 2022

The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards.

There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021.

The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

Nominees need to be FDA-approved for the market within the last five years and show major potential to affect healthcare. The winners will be announced in October at the Prix Galien USA Awards in New York City.

This year, the foundation nominated 24 medical device innovations, 22 biotechnology products and 33 pharmaceutical agents. The devices range from an intraocular lens to a bariatric stapler.

“Every year, evaluating and recognizing the amazing submissions that come through for the Prix Galien Awards is one of the greatest honors,” said Dr. Sue Des…

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Medline to distribute Visby handheld STI test to healthcare orgs

Medline announced it is supplying Visby Medical Sexual Health Click handheld PCR test to healthcare organizations.

The point-of-care device for sexually transmitted infections (STIs) is an all-in-one unit that is FDA cleared to provide a diagnosis in under 30 minutes. The company will provide the tests to urgent care centers, student health centers, women’s health facilities and community health centers.

Visby’s PCR test allows clinicians to discuss results and prescribe personalized treatment during patient visits to eliminate the need for presumptive treatment.

“Our partnership with Visby demonstrates our commitment to bringing leading-edge medical innovations to the point of care that revolutionize patient care,” said Doug Sharpe, VP of Lab Capital at Medline. “Winning several awards for design innovation and excellence, the Visby device is the first PCR test of its kind and gives clinicians a tool to help improve patient outcomes.”

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Visby Medical raises $135M in expanded Series E

Visby Medical announced today that it added $35 million to an expanded, oversubscribed Series E financing round.

San Jose, California-based Visby plans to use the additional investment, which brings its Series E to $135 million in total, to scale production capacity, expand its product menu to include respiratory health tests and anti-microbial resistance panels and to bring PCR diagnostics to consumers at home.

The company develops PCR diagnostic technology designed to address the significant rise in infectious diseases. Its FDA-cleared sexual health click test has already launched in the U.S. in settings such as urgent care and women’s health clinics to detect gonorrhea, chlamydia and trichomonas via self-collected vaginal swabs and deliver results in less than 30 minutes, eliminating the need for presumptive treatment.

According to a news release, Lightrock led the funding round, joining existing Series E investors including  John Doerr, Cedars …

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Visby Medical triggers $25.5M contract option with BARDA to develop at-home COVID-19/flu test

Visby Medical announced today that it picked up $25.5 million in government funding to develop an at-home flu/COVID-19 diagnostic.

San Jose, California-based Visby executed an option in a contract from the Biomedical Advanced Research and Development Authority (BARDA) to pick up an additional $25.5 in funding for the development and validation of the at-home combination test. The incremental funding follows the initial contract awarded in February 2021.

According to a news release, Visby designed its developmental-stage flu-COVID-19 PCR test as a single-use, handheld, all-in-one device for detecting and distinguishing between influenza A, influenza B and SARS-CoV-2 all in one sample. It delivers results in less than 30 minutes and requires no additional equipment.

“We are honored by BARDA’s confidence in our team’s ability to develop this test and bring it to market, and we’re excited to be a part of the solution to keep kids in s…

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Visby Medical wins FDA authorization for point-of-care COVID-19 PCR test

Visby Medical announced today that it received FDA emergency use authorization (EUA) for its rapid COVID-19 test at point-of-care.

San Jose, Calif.-based Visby’s rapid PCR COVID-19 test received EUA previously but can now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, according to a news release.

Visby’s testing device has palm-sized dimensions and eliminates the need for an additional instrument or reader so that it can provide fast, accurate results at the point of care, requiring only a power plug. Additionally, Visby said it has the potential capability to run pooled tests in the future.

“This latest authorization will have a significant impact on COVID-19 testing, especially in situations when an accurate result is needed quickly,” Visby chief medical officer Dr. Gary Schoolnik said in the release. “Visby’s test can now be used directly at the point of …

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