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.
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.
Visby Medical Expands Series E Round to Over $135 Million

Visby Medical extends Series E round to include an additional $35 million, totaling more than $135 million raised.
Visby Reaffirms Support for Women’s Access to Healthcare

Visby Medical’s CEO reaffirms support for women’s healthcare access, announcing travel expense reimbursement for employees for out-of-state pregnancy-related care.
AACC selects Visby Medical as 2022 Disruptive Technology Award Finalist

AACC selects Visby Medical as a finalist for the 2022 Disruptive Technology Award for its handheld point-of-care PCR diagnostic technology.
Visby Medical Appoints Everett Cunningham to Board of Directors

Visby Medical today announced Everett Cunningham has been appointed to the company’s Board of Directors.
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.
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
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)
Visby Medical Raises over $100 Million in Series E Financing

Investment will accelerate the development of revolutionary rapid, single-use PCR diagnostic technology for home use