Visby

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Second Generation Sexual Health Test for Women

Retrieved on: 
Tuesday, March 14, 2023

The Visby Medical Sexual Health test is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.

Key Points: 
  • The Visby Medical Sexual Health test is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.
  • The CLIA-waived, Sexual Health POC test provides accurate results in under 30 minutes, enabling clinicians to test, talk and accurately treat with confidence in a single patient visit.
  • "The Visby Sexual Health Test has been a game changer for us.
  • The Visby test is a win-win, helping fight antibiotic resistance as well as the spread of untreated infection, while empowering patients to engage health services with greater confidence."

Sapphiros Taps Teresa Abraham for VP of Scientific and Technical Affairs

Retrieved on: 
Wednesday, January 25, 2023

BOSTON, Jan. 25, 2023 /PRNewswire/ -- Sapphiros, a platform dedicated to building the next generation of consumer diagnostics, backed by KKR, is pleased to announce the appointment of Teresa Abraham, PhD, as its new Vice President of Scientific and Technical Affairs.

Key Points: 
  • BOSTON, Jan. 25, 2023 /PRNewswire/ -- Sapphiros, a platform dedicated to building the next generation of consumer diagnostics, backed by KKR, is pleased to announce the appointment of Teresa Abraham, PhD, as its new Vice President of Scientific and Technical Affairs.
  • Dr. Abraham will be responsible for partnerships that accelerate technology development and clinical research for a portfolio of Med Tech companies under the Sapphiros umbrella.
  • She brings a wealth of experience in scientific research, technical development, and policy advocacy.
  • Prior to joining Sapphiros, Dr. Abraham was VP of Scientific and Technical Partnerships at Visby Medical in San Jose, CA, where she secured over $70 million in non-dilutive funding to accelerate platform and product development.

Visby Medical™ Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings

Retrieved on: 
Tuesday, January 3, 2023

SAN JOSE, Calif., Jan. 3, 2023 /PRNewswire/ -- 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.

Key Points: 
  • SAN JOSE, Calif., Jan. 3, 2023 /PRNewswire/ -- 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.
  • The Visby Medical Respiratory Health Test is a fast, polymerase chain reaction (PCR) device that detects and differentiates between upper respiratory infections caused by Influenza (Flu) A & B, and SARS-CoV-2 (COVID-19).
  • Visby Medical has received EUA from the FDA for its Respiratory Health point of care test.
  • He further added, "Use of the Visby Respiratory Health Test at the point of care in urgent care clinics and emergency rooms will transform how patients with respiratory symptoms are diagnosed and treated."

Visby Medical™ CEO Reaffirms Support for Women's Healthcare Access, Announces Travel Expense Reimbursement for Employees for Out-of-State Pregnancy-Related Care

Retrieved on: 
Monday, June 27, 2022

The new Visby policy ensures that its employees and their dependents will continue to have access to safe and legal reproductive health care.

Key Points: 
  • The new Visby policy ensures that its employees and their dependents will continue to have access to safe and legal reproductive health care.
  • Visby Medical CEO Reaffirms Support for Women's Healthcare Access, Announces Travel Expense Reimbursement for Employees
    The idea that patients deserve autonomy in their own health, including sexual and reproductive health, is at the heart of Visby's mission.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.
  • Visby Medical is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of care, and eventually for use at home.

Visby Medical Appoints Everett Cunningham to Board of Directors

Retrieved on: 
Wednesday, May 25, 2022

SAN JOSE, Calif., May 25, 2022 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced Everett Cunningham has been appointed to the company's Board of Directors.

Key Points: 
  • SAN JOSE, Calif., May 25, 2022 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced Everett Cunningham has been appointed to the company's Board of Directors.
  • "I am thrilled to welcome Everett to the Visby team," said Visby Medical Founder and CEO Adam de la Zerda, Ph.D. "Everett is a dynamic executive with deep experience across the pharmaceutical and diagnostic industries.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.
  • Visby Medical is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of care, and eventually for use at home.

Visby Medical Executes Contract Option with BARDA for $25.5M to Develop Rapid Flu-COVID PCR Test Designed for At-Home Use

Retrieved on: 
Friday, March 25, 2022

SAN JOSE, Calif., March 25, 2022 /PRNewswire/ -- Visby Medical™, a leading medical diagnostic company, 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).The developmental-stage Flu-COVID PCR Test is a single-use, handheld, all-in-one PCR device that detects and distinguishes between influenza A, influenza B, and SARS-CoV-2 from one sample, delivers results in less than 30 minutes, and requires no additional equipment. This incremental funding builds on the initial contract, announced February 2, 2021.

Key Points: 
  • Designed for ease-of-use with minimal set-up time, the test offers a fast sample-to-result time of less than 30 minutes with an expected accuracy rate similar to lab-based PCR tests.
  • In the first phase of the contract, BARDA-supported efforts to obtain FDA emergency use authorization for Visby's rapid, single-use Flu-COVID PCR Test in CLIA-waived point of care settings.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.
  • Visby Medical is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of care, and eventually for use at home.

Visby Medical to Present at the J.P. Morgan 40th Annual Healthcare Conference

Retrieved on: 
Monday, January 10, 2022

SAN JOSE, Calif., Jan. 10, 2022 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced that it will make its debut appearance at the 40th Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • SAN JOSE, Calif., Jan. 10, 2022 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced that it will make its debut appearance at the 40th Annual J.P. Morgan Healthcare Conference.
  • The live presentation will be streamed through the J.P. Morgan Healthcare Conference portal, and a recording of the presentation will be available after the event.
  • Visby Medical is a diagnostics company that is transforming the order of diagnosis and treatment for infectious diseases.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.

Visby Medical Appoints Terri S. Bresenham and Scott Edward Mendel to Board of Directors

Retrieved on: 
Tuesday, January 4, 2022

SAN JOSE, Calif., Jan. 4, 2022 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced Terri Bresenham and Scott Mendel have been appointed to the company's Board of Directors.

Key Points: 
  • SAN JOSE, Calif., Jan. 4, 2022 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced Terri Bresenham and Scott Mendel have been appointed to the company's Board of Directors.
  • Bresenham was most recently chief innovation officer at General Electric Corporation and Mendel was chief executive officer of GenMark Diagnostics.
  • Together they bring over 45 cumulative years of experience in the medical device industry to the company's board.
  • Mendel also serves on the Board of Directors of Akoya Biosciences and is on the advisory board of Specific Diagnostics.Heearned a B.S.

Visby Medical Appoints Industry Veteran Thomas Prescott as Chairman of the Board

Retrieved on: 
Thursday, October 28, 2021

SAN JOSE, Calif., Oct. 28, 2021 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced 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.

Key Points: 
  • SAN JOSE, Calif., Oct. 28, 2021 /PRNewswire/ -- Visby Medical , a leading medical diagnostic company, today announced 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.
  • "With decades of experience in multiple leadership positions at innovative medical technology companies, Thomas is well-positioned as a valuable resource for Visby and will help guide our growth.
  • We are very pleased to have him on board," said Visby Medical Founder and CEO Adam de la Zerda.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.

FDA Grants Emergency Use Authorization for Visby Medical's COVID-19 RT-PCR Test for Pooled Samples

Retrieved on: 
Monday, September 13, 2021

SAN JOSE, Calif., Sept. 13, 2021 /PRNewswire/ -- Visby Medical™ announced today that its instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for testing pooled patient samples in high-complexity Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. This authorization extends the previous EUA for single patient sample testing at the point of care.  Furthermore, this validates the flexibility and adaptability of the Visby Medical innovative, palm-sized PCR technology by expanding its proven capabilities from individual, single-use testing to pooled testing of up to five patient samples at once.  

Key Points: 
  • Furthermore, this validates the flexibility and adaptability of the Visby Medical innovative, palm-sized PCR technology by expanding its proven capabilities from individual, single-use testing to pooled testing of up to five patient samples at once.
  • The Company's COVID-19 test pooling protocol enables high-complexity clinical laboratories to combine up to five patient samples into a single devicefor processing.
  • Visby Medical is a diagnostics company that is transforming the order of diagnosis and treatment for infectious diseases.
  • The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases.