Seventh Sense Biosystems Incorporated, a company that has designed and developed TAP, the world's first push-button blood collection device, has announced today that TAP has received United States Food and Drug Administration (FDA) 510(k) approval.
The technology is claimed to represent a landmark innovation in the blood collection industry, where one billion blood draws are performed each year for diagnostic testing.
Blood can be drawn with TAP by placing it on the upper arm and collection starts with a press of a button. The process takes two to three minutes.
The current clearance allows healthcare workers to use TAP to collect capillary blood for haemoglobin A1c (HbA1c) testing, which is routinely used to monitor blood sugar levels in diabetic or pre-diabetic patients. 7SBio is working with the FDA to expand the use of TAP to add additional tests, as well as 'at home' collection.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial