The FDA has cleared Drawbridge Health’s blood collection device designed to help monitor long-term blood sugar levels in people with diabetes, which the company describes as easier and less painful than a hypodermic needle.

Roche said recently that it has received US Food and Drug Administration 510(k) clearance for its Cobas TV/MG test for the detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.

A November 2018 FDA inspection has resulted in a warning letter for Zeller Power Products. The Wallace, ID-based company makes a replacement battery for Cardiac Science's PowerHeart Automated External Defibrillator (AED) G3.

Bacillusbacteria detection devices were previously unclassified, known as preamendment devices, since they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act

FDA published draft guidance on Feb. 25, 2019 on submission of bioavailability (BA) information for oral dosage drugs in investigation new drug applications (INDs), new drug applications (NDAs), and NDA supplements. In the guidance, FDA prov

Becton Dickinson said today that the US Food and Drug Administration has granted 510(k) clearance for its BD Max enteric viral panel, a molecular diagnostic test for the detection and differentiation of pathogens that cause viral gastroenter

A clinical assay from Zeesan Biotech to detect and identify 14 high-risk genotypes of human papillomavirus has been approved by the China State Food and Drug Administration, company announced recently. The MeltPro High Risk HPV test, which w

Qiagen announced today that the US Food and Drug Administration has approved the expanded use of the companys Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic for Pfizers Vizimpro (dacomitinib) for first-line treatment

Roche said recently that the US Food and Drug Administration has approved its Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZenecas cancer drug Iressa (gefitinib) for first-line treatment of patients with non-small ce