Recent news, press releases and company announcements.
March 14, 2023
Visby Medical™ Receives FDA Clearance and CLIA Waiver for second Generation Sexual Health Test for Women
Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the FDA for its 2nd generation point of care (POC) test.
January 3, 2023
Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for Use in CLIA Waived Settings
Visby Medical announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test.
June 29, 2022
Visby Medical extends Series E round to include an additional $35 million, totaling more than $135 million raised.
June 27, 2022
Visby Medical’s CEO reaffirms support for women’s healthcare access, announcing travel expense reimbursement for employees for out-of-state pregnancy-related care.
June 15, 2022
AACC selects Visby Medical as a finalist for the 2022 Disruptive Technology Award for its handheld point-of-care PCR diagnostic technology.
May 25, 2022
Visby Medical today announced Everett Cunningham has been appointed to the company’s Board of Directors.
April 4, 2022
Chiricahua Community Health Centers, Inc., Launches STI Testing Program for Women with Same-Day Results
The Body Agency Collective, Visby Medical, Inc. and CCHCI observe National STD Awareness Month with women’s health initiative on US-Mexico border.
CCHCI among first healthcare providers in the nation to adopt new handheld PCR technology to detect gonorrhea, chlamydia and trichomoniasis in a single visit.
March 29, 2022
Urgent Care For Children Collaborates With Visby Medical To Provide New Gold Standard Diagnostic For Sexually Transmitted Infections
Pediatric urgent care provider among first in the US to adopt new point-of-care STI diagnostic device in adolescents and young adults
March 25, 2022
Visby Medical Executes Contract Option with BARDA for $25.5M to Develop Rapid Flu-COVID PCR Test Designed for At-Home Use
Visby Medical today announced that it has received an additional $25.5M in federal funding to develop and validate an at-home combination Flu-Covid test from the Biomedical Advanced Research and Development Authority (BARDA)
March 1, 2022
Investment will accelerate the development of revolutionary rapid, single-use PCR diagnostic technology for home use
January 10, 2022
Visby Medical™ announced that it will make its debut appearance at the 40th Annual J.P. Morgan Healthcare Conference.
January 4, 2022
Visby Medical™ today announced Terri S. Bresenham and Scott Edward Mendel have been appointed to the company ’s Board of Directors.
December 1, 2021
Clinical Data of The Visby Medical Sexual Health Click Test Published in Journal of the American Sexually Transmitted Diseases Association
Integration of the Visby Medical sexually transmitted infections (STI) panel into clinical practice could significantly reduce over- and under-treatment of Chlamydia, Gonorrhea, and Trichomonas
October 28, 2021
Thomas Prescott, former president and chief executive officer (CEO) of Align Technology and Cardiac Pathways, will join as the company’s new chairman of the board.
October 21, 2021
Visby Medical™, a leading medical diagnostic company, today announced the appointment of John W. Kuo as the company’s new Chief Legal Officer. An experienced veteran in corporate law, Kuo brings more than 30 years of experience across multiple industries, including nearly 20 years in the healthcare industry.
September 13, 2021
The Visby Medical™ instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test was granted Emergency Use Authorization (EUA) by the FDA
August 30, 2021
Visby Medical™ Receives FDA Clearance and CLIA Waiver at the Point of Care for PCR Sexual Health Test
The Visby Medical Sexual Health Click Test is the first instrument-free PCR test for the detection of Chlamydia, Gonorrhea, and Trichomonas, with results available within 30 minutes, during the patient visit.
July 16, 2021
Visby Medical appoints Mark Ibison as Chief Financial Officer, Christopher J. Jowett as Chief Commercial Officer, and Alicia Zuiker as Chief People Officer
February 10, 2021
Expanding critical access to the only single-use, rapid PCR test, at the point of care.
February 2, 2021
Visby Medical speeds development of a rapid Flu-COVID PCR test designed for at-home use with BARDA funding
Visby Medical pairs speed with the accuracy of gold-standard PCR testing in a single-use device, so doctors don’t have to fight blind.
October 6, 2020
Visby Medical, an infectious disease diagnostic company, received funding from the National Institutes of Health as part of the organization’s Rapid Acceleration of Diagnostics (RADx) program, an initiative that aims to combat SARS-CoV-2 and increase national testing capacity for COVID-19.
September 16, 2020
Visby Medical’s Personal PCR Device Receives FDA Emergency Use Authorization for Moderate-Complexity Lab Environments
Seven-year-old startup emerges from stealth mode, provides adaptable and rapid testing technology to frontline lab personnel fighting the pandemic
August 5, 2020
Rapid diagnostic for gonorrhea wins $19 million federal prize competition to combat antibiotic resistance
As appeared in NIH website 8/5/20
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