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SAMDAILY.US - ISSUE OF AUGUST 21, 2020 SAM #6840
SOLICITATION NOTICE

66 -- Hemodynamics and Oximetry Monitoring System

Notice Date
8/19/2020 2:18:08 PM
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
FDA OFFICE OF ACQ GRANT SVCS ROCKVILLE MD 20857 USA
 
ZIP Code
20857
 
Solicitation Number
75F40120Q00121
 
Response Due
8/26/2020 7:00:00 AM
 
Archive Date
09/10/2020
 
Point of Contact
Teddy Weng, Phone: 2404027526
 
E-Mail Address
teddy.weng@fda.hhs.gov
(teddy.weng@fda.hhs.gov)
 
Small Business Set-Aside
SBA Total Small Business Set-Aside (FAR 19.5)
 
Description
The Optical Diagnostics Laboratory (ODD), a division within the Division of Biomedical Physics (DBP) performs research on novel optical imaging systems. Current projects focus on evaluating performance of near infrared spectroscopy (NIRS) and photoacoustic imaging (PAI) systems used to measure blood Oxygen Saturation (SO2). A critical need for these projects is a device that provides clinically relevant ""gold standard"" measurements of SO2 in situ within tissue phantoms or small animals. A suitable device would be a compact minimally invasive catheter probe based on optical sensing. The device should be a well-validated system that is capable of accurately measuring absolute blood oxygen saturation levels. This need for the ODD can be fulfilled by purchasing a hemodynamics and oximetry monitoring system. A hemodynamics and oximetry monitoring system directly measures blood pressure from inside the veins, heart and arteries. They also measure blood flow and how much oxygen is in the blood. In addition, these systems have interfaces to help document diagnostic catheterizations, coronary, peripheral and electrophysiology (EP) procedures. The most common types of invasive hemodynamic monitors are central venous catheters, pulmonary artery catheters, and arterial pulse-wave analysis. This collaboration between OSEL and DBP will support the Center for Devices and Radiological Health (CDRH)�s mission in the development of studies and new development in medical technologies that identify abnormal physiology in measurements of blood pressure from inside the veins, heart and arteries which identify abnormal physiology and intervene before complications that can lead to organ failure and death.
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/8a83bb8f4d484d9eace45cfaf65e8d9c/view)
 
Place of Performance
Address: Silver Spring, MD 20993, USA
Zip Code: 20993
Country: USA
 
Record
SN05765792-F 20200821/200819230205 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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