Visby Medical

Timeline

1. May 27, 2026 FDA FDA 510(k) clearance: Visby Medical Flu and COVID-19 Test — K253971, May 27, 2026. Applicant at approval: Visby Medical, Inc. source ↗
2. Oct 1, 2025 FDA FDA 510(k) clearance: Visby Medical Men's Sexual Health Test — K251501, Oct 1, 2025. Applicant at approval: Visby Medical, Inc. source ↗
3. Mar 28, 2025 FDA FDA De Novo grant: Visby Medical Women's Sexual Health Test — DEN240020, Mar 28, 2025. Applicant at approval: Visby Medical, Inc. source ↗
4. Feb 19, 2025 FDA FDA 510(k) clearance: Visby Medical Respiratory Health Test — K242526, Feb 19, 2025. Applicant at approval: Visby Medical, Inc. source ↗

FDA records (last 2 years)

• May 27, 2026 FDA 510(k) clearance: Visby Medical Flu and COVID-19 Test — K253971, May 27, 2026. Applicant at approval: Visby Medical, Inc. source ↗
• Oct 1, 2025 FDA 510(k) clearance: Visby Medical Men's Sexual Health Test — K251501, Oct 1, 2025. Applicant at approval: Visby Medical, Inc. source ↗
• Mar 28, 2025 FDA De Novo grant: Visby Medical Women's Sexual Health Test — DEN240020, Mar 28, 2025. Applicant at approval: Visby Medical, Inc. source ↗
• Feb 19, 2025 FDA 510(k) clearance: Visby Medical Respiratory Health Test — K242526, Feb 19, 2025. Applicant at approval: Visby Medical, Inc. source ↗

NIH awards 5

Annual award amounts. Total $2.5M.

• Mar 22, 2019 NIH award 1R44AI143012-01A1 FY2019: $300,000 awarded for that fiscal year; activity R44 (SBIR); PI SCHOOLNIK, GARY; recipient as written: VISBY MEDICAL, INC., San Jose, CA. Development, Preclinical and Preanalytical source ↗
• 2019 NIH contract (government contract; not a grant and not an investment round) 75N93019C00019-0-9999-1 FY2019: $300,000 awarded for that fiscal year; activity N43 (OTHER_NIH); PI WONG, SEASON; recipient as written: VISBY MEDICAL, INC., San Jose, CA. Rapid, Point- source ↗
• Aug 1, 2018 NIH award 1R61AI140468-01 FY2018: $404,129 awarded for that fiscal year; activity R61 (OTHER_NIH); PI SCHOOLNIK, GARY; recipient as written: VISBY MEDICAL, INC., San Jose, CA. Single-use, disposable PCR home self-tes source ↗
• Jul 19, 2018 NIH award 5R44AI134565-02 FY2018: $467,645 awarded for that fiscal year; activity R44 (SBIR); PI LONEY, GREGORY C; recipient as written: VISBY MEDICAL, INC., San Jose, CA. Commercialization of low cost, disposable, p source ↗
• Aug 18, 2017 NIH award 1R44AI134565-01 FY2017: $980,734 awarded for that fiscal year; activity R44 (SBIR); PI LONEY, GREGORY C; recipient as written: VISBY MEDICAL, INC., San Jose, CA. Commercialization of low cost, disposable, p source ↗