Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
Sekisui Diagnostics

Download Mobile App





New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization

By HospiMedica International staff writers
Posted on 18 Sep 2020
A new portable PCR COVID-19 test kit has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for use in lab environments.

Visby Medical (San Jose, CA, USA), a Silicon Valley startup, has become the first company to be granted FDA EUA for a portable PCR COVID-19 test kit, which it has named Personal PCR. More...
Since the last seven years, Adam de la Zerda, the founder and CEO of Visby, has been working on shrinking the traditional PCR testing machine which is the size of a large microwave to a portable size that would fit in the palm. By bringing the power of the lab in the palm of the hand, the portable Personal PCR has the potential to be used by anyone, anywhere.

A sample taken via a nasal swab is inserted into the kit which features LED lights that indicate the test is running and alerts when it is completed. Visby’s portable Personal PCR test goes anywhere to deliver the serious infection result needed in less than 30 minutes. The single-use test with less than two minutes of hands-on time is easy to use, and delivers fast and accurate result right at the point of need. Visby’s Personal PCR is currently limited to lab use, although the company’s ultimate goal is to make the test available over the counter to anyone, anywhere at an affordable price.

“With our device you get the results you need while you’re still face to face with the patient, helping you make better and more timely decisions,” said Dr. Gary Schoolnik, Chief Medical Officer, Visby Medical.

“PCR, when appropriately applied, generates a highly sensitive and precise result. Visby’s PCR technology is so sensitive that it will pick up a signal that is likely to otherwise be missed,” said Dr. Shlomo Melmed, Executive Vice President of Academic Affairs, and Dean of the Medical Faculty and Professor of Medicine, Cedars-Sinai. “They have miniaturized PCR, validating it in the most rigorous fashion that satisfies both the compliance agencies as well as practicing physicians. This is a very important patient-friendly advance which will lead to a new class of point of care diagnostics.”

“The COVID-19 pandemic has highlighted the vital importance of very accurate, quick-response, single-use tests. With them, lives can return to normal both in developed and developing countries without causing numerous casualties,” said Sir Ronald Cohen, preeminent international philanthropist, venture capitalist, private equity investor and social innovator. “Visby’s team has shown how brilliant entrepreneurship can bring groundbreaking innovation in testing, not just for COVID-19, but for all infectious diseases, now and in the future.”

Related Links:
Visby Medical


Gold Member
NEW PRODUCT : SILICONE WASHING MACHINE TRAY COVER WITH VICOLAB SILICONE NET VICOLAB®
REGISTRED 682.9
Hand-held Hemoglobin Analyzer
DiaSpect Tm
Digital Radiography System (Ceiling Free)
Digix CF Series
Hypodermic Syringe
SurTract™ Safety Syringe
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to HospiMedica.com and get access to news and events that shape the world of Hospital Medicine.
  • Free digital version edition of HospiMedica International sent by email on regular basis
  • Free print version of HospiMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of HospiMedica International in digital format
  • Free HospiMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Critical Care

view channel
Image: Masimo smartSET pulse oximetry with PPG AFib and OIRD Detection (Photo courtesy of Masimo)

Smart Pulse Oximetry Supports Earlier Recognition of Arrhythmias and Respiratory Risk

On general care floors, respiratory compromise and arrhythmias can develop between routine checks. Atrial fibrillation often goes undiagnosed in older adults, while opioid-induced respiratory depression... Read more

Surgical Techniques

view channel
Image: Restrata Matrix and Solventum V.A.C. Therapy brings two advanced technologies together into one path to support active wound healing. (Photo courtesy of Solventum)

Combined Wound Healing Approach Pairs Synthetic Scaffold With Negative Pressure Therapy

Managing complex wounds requires both structural support for tissue repair and a controlled environment that protects the healing process. Frequent dressing changes can disrupt the wound bed and add complexity... Read more

Patient Care

view channel
Image: Researchers evaluated the Omni 128 cm long-axial field-of-view PET/CT system, which captures more of the body and radiotracer signal at once, potentially enabling shorter scans. (Photo courtesy of GE HealthCare)

Total-Body PET/CT Scanner Enables One-Minute Diagnostic-Quality Cancer Imaging

Positron emission tomography/computed tomography (PET/CT) combines radiotracer-based functional imaging with anatomical detail to diagnose, stage, and monitor cancer. Conventional scanners image the body... Read more

Medical Imaging

view channel
Image Credit: Adobe Stock

AI Model Detects Hidden Disease Signals in Routine CT Scans

Computed tomography (CT) scans are often performed to answer a specific diagnostic question, which can leave other potentially important findings outside the immediate clinical focus. As a result, opportunities... Read more

Point of Care

view channel
Image Credit: 123RF

Continuous Glucose Monitoring Identifies Cardiometabolic Risk in Adults Without Diabetes

Dysglycemia—abnormal blood glucose regulation—can fluctuate throughout the day and often escape conventional screening. Clinicians typically rely on fasting plasma glucose and hemoglobin A1c, which offer... Read more

Business

view channel
Image: Steris is expanding its healthcare consumables portfolio through an agreement to acquire Xodus Medical, a surgical products business focused on patient and operating room staff safety.

Steris to Expand Surgical Safety Portfolio With $2.1 Billion Xodus Medical Deal

Steris has signed a definitive agreement to acquire Xodus Medical, a specialty surgical products business based in Pennsylvania, for $2.1 billion at closing. The acquisition will expand Steris’s healthcare... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.