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Handheld ultrasound devices in point-of-care settings

Handheld ultrasound devices bring imaging to the bedside, where rapid tests are also used. This short explainer describes the category. First Diagnostic™ Corporation does not supply ultrasound devices.

What handheld ultrasound devices are

Handheld ultrasound devices are pocket-size ultrasound systems. A transducer connects by cable or wirelessly to a phone, a tablet or a small dedicated display, and shows real-time images of structures inside the body.

Their use at the bedside by the treating clinician is called point-of-care ultrasound. Trained clinicians use it for focused examinations, for example of the heart, lungs, abdomen, pregnancy or muscles and joints, and to guide procedures.

How ultrasound sits beside rapid tests

The two categories answer different questions. Ultrasound shows anatomy and movement. Rapid tests detect a substance in a specimen: an antigen, an antibody, a hormone or a protein marker. A clinic may use both in the same visit, with imaging and a lateral flow test each adding one piece of information.

Both are used close to the patient, and both depend on training, written procedures and records. They are regulated differently: an ultrasound system is a medical device, while a rapid test is an in vitro diagnostic device. See what is a medical device and point-of-care testing for more detail.

Limits to keep in mind

  • Image acquisition and interpretation depend on the operator’s training.
  • A focused bedside examination does not replace a comprehensive imaging study when one is indicated.
  • Images stored on mobile devices need the same data protection as any other patient record.

First Diagnostic and ultrasound

First Diagnostic does not supply handheld ultrasound devices today. Its range consists of lateral flow rapid tests for professional in vitro diagnostic use, listed in the rapid tests catalog, including ToRCH and prenatal rapid tests.

Manufacturers of point-of-care devices who are looking for sales representation can read about our services and contact us. A related category is covered in cardiovascular monitoring devices.

Frequently asked questions

No. First Diagnostic does not supply ultrasound devices today. The current range is lateral flow rapid tests for professional use.

No. Ultrasound is an imaging method. A rapid test is an in vitro diagnostic device that analyzes a specimen such as blood, urine or a swab.

Clinicians trained in the specific examination, working under the rules and credentialing requirements of their country and institution.

Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.