ADAC Laboratories Receives FDA Clearance for Molecular Coincidence Detection (MCD) Product

Strategic Insights

Nov 26, 1995 — 1 min read

ADAC Laboratories announced that it has received formal clearance from the Food and Drug Administration (FDA) to market its Molecular Coincidence Detection (MCD) product for use in ADAC's nuclear medicine camera systems. This breakthrough technology enables ADAC's VERTEX EPIC and SOLUS EPIC gamma cameras to perform both single photon emission computerized tomography (SPECT) and coincidence imaging procedures. Coincidence imaging, previously only available on very costly dedicated positron emission tomography (PET) systems, offers valuable diagnostic information for a number of oncologic, cardiac, and neurological conditions.

Key Takeaways:

The FDA has cleared ADAC's Molecular Coincidence Detection (MCD) product for use in ADAC's nuclear medicine camera systems.
MCD technology enables ADAC's gamma cameras to perform both SPECT and coincidence imaging procedures, expanding its diagnostic capabilities.
Coincidence imaging is valuable for diagnosing oncologic, cardiac, and neurological conditions, previously only available on expensive PET systems.
ADAC will conduct multi-center trials with MCD in early 1996 to document clinical efficacy and cost-effectiveness.
ADAC is the world market leader in nuclear medicine and a leading supplier of radiology and laboratory information systems in North America.
ADAC has received a site visit for the Malcolm Baldrige National Quality Award for the second consecutive year.

Statistics:

1995: ADAC Laboratories receives FDA clearance for MCD product.
Early 1996: ADAC commences multi-center trials with MCD to document clinical efficacy and cost-effectiveness.
1995: ADAC Laboratories is the world market leader in nuclear medicine and a leading supplier of radiology and laboratory information systems in North America.
Second consecutive year: ADAC receives a site visit for the Malcolm Baldrige National Quality Award.

Sources:

BUSINESS WIRE, Nov. 27, 1995
ADAC Laboratories
Food and Drug Administration (FDA)
Radiological Society of North America

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