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February 23, 2017

FDA grants 510(k) clearance to 7SBio’s blood collection device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Seventh Sense Biosystems' (7SBio) new push-button blood collection device TAP.

The US Food and Drug Administration (FDA ) has granted 510(k) clearance to Seventh Sense Biosystems' (7SBio) new push-button blood collection device TAP.

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The new device is claimed to provide a virtually painless, simple and fast blood collection process and eliminates the need for insertion of a long needle into a vein or lancet to a fingertip.

TAP can be placed on the upper arm and blood collection starts with a simple press of a button and takes about 2-3 minutes to be complete.

"TAP has the potential to transform blood collection from an inconvenient, stressful, and painful experience to one people can do themselves anywhere."

7SBio chief executive officer Howard Weisman said: "No one likes getting blood drawn, but blood is the single-most important source of medical information in healthcare today, with about 90% of all diagnostic information coming from blood and its components.

"TAP has the potential to transform blood collection from an inconvenient, stressful, and painful experience to one people can do themselves anywhere, making health monitoring much easier for both healthcare professionals and patients."

The current clearance allows the use of the device to collect capillary blood for hemoglobin A1c (HbA1c) testing to monitor blood sugar levels in diabetic or pre-diabetic patients.

It is expecyed that TAP can facilitate efficient blood collection in reference labs, hospitals, retail pharmacies, doctors' offices, wellness screenings, molecular diagnostics testing, athlete monitoring and clinical trials.

7SBio is currently working with the FDA to expand TAP's clearance for use in additional tests.

The firm also intends to develop and commercialise different versions of the device that would allow users to collect blood anywhere and anytime.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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