JD Supra

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as ...
Silicon Prairie News

University Medical Devices raised $1.6M to launch the MicroWash device for nasal specimen collection

University Medical Devices (UMD) closed a $1.6M round of seed funding led by Bright Minds Capital Partners, with participation from Invest Nebraska, AV Legacy Holdings, LLC and UMD executives. The ...
News Medical

Puritan introduces new line of liquid, agar gel collection devices for bacteriological applications

Puritan Medical Products, North America's largest manufacturer of swabs and specimen collection devices, is pleased to announce Opti-Tranz™ and Opti-Tranz™ Plus, a brand new line of traditional liquid ...
Business Wire

Biodesix Study Shows Proprietary Device Collects, Separates, and Transports Blood at Ambient Temperature

BOULDER, Colo.--(BUSINESS WIRE)--Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, today announced publication of a peer-reviewed study supporting its patented blood ...
Business Insider

OraSure’s DNA Genotek Subsidiary Unveils First In-Home Self-Collection Device for Metabolomics

OTTAWA, June 17, 2020 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical ...
Business Wire

Biodesix Secures U.S. Patent for Proprietary Blood Specimen Collection Device

BOULDER, Colo.--(BUSINESS WIRE)--Biodesix, Inc., today announced it has been issued U.S. Patent Number 10,422,729, which covers the Biodesix Collection Device (BCD). The new device offers improved ...
La Grande Observer

New Study Demonstrates Potential for Enhanced Accuracy of Blood Cultures with Steripath® Initial Specimen Diversion Device® (ISDD®) for Central Line Draws

SEATTLE, March 5, 2025 /PRNewswire/ — Magnolia Medical Technologies, Inc., the pioneer in Initial Specimen Diversion Device ® (ISDD ®) technology, today announced groundbreaking new findings from an ...
Nasdaq

OraSure’s Oragene®•Dx Saliva Collection Kit Included in Industry’s First FDA Authorization for a Whole Exome Sequencing Platform

BETHLEHEM, Pa., Jan. 21, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and ...
Business Insider

OraSure’s DNA Genotek Subsidiary Receives FDA Emergency Use Authorization for its ORAcollect®·RNA Saliva Collection Device for SARS CoV-2

BETHLEHEM, Pa., Nov. 03, 2020 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and ...
Nasdaq

OraSure’s OMNIgene®·ORAL Collection Device Receives FDA Emergency Use Authorization for SARS CoV-2

BETHLEHEM, Pa., Oct. 19, 2020 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and ...
Reuters

FDA adds all blood sample collection tubes to medical device shortage list

Jan 19 (Reuters) - The U.S. health regulator said on Wednesday it was expanding the medical device shortage list to include all blood specimen collection tubes due to supply challenges led by an ...