TIDMEKF

RNS Number : 1893K

EKF Diagnostics Holdings PLC

09 April 2018

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

EKF Diagnostics Holdings plc

("EKF", the "Company")

US FDA approval for Diaspect Tm

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care business, announces US Food and Drug Administration 510(k) clearance and CLIA waiver by statute for the Company's hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm, approving the product for use in point of care and Certificate of Waiver settings.

The DiaSpect Tm provides users with accurate hemoglobin measurements within two seconds of the microcuvette being placed into the analyzer. It is palm-sized, easy to transport and is battery operated for remote use.

For more information on the DiaSpect Tm see: www.ekfdiagnostics.com/diaspect.html

Commenting, Julian Baines, CEO of EKF, said:

"The FDA approval of DiaSpect Tm is part of our overall strategy to widen the range of regulatory approvals for our existing product range and to drive sales growth for these products across additional geographies. The US market is a key target for our DiaSpect Tm product, where we see a significant need for an easy to use, accurate and portable hemoglobin measurement system that can deliver laboratory quality results to patients in the clinic within seconds."

Enquiries:

 
EKF Diagnostics Holdings plc                                 www.ekfdiagnostics.com 
Christopher Mills, Non-Executive Chairman                        Tel: 029 2071 0570 
Julian Baines, CEO 
 
Richard Evans, FD & COO 
 
 
N+1 Singer (Nomad & Broker)                                      Tel: 020 7496 3000 
Alex Price / Shaun Dobson 
 
 
Walbrook PR Limited                        Tel: 020 7933 8780 or ekf@walbrookpr.com 
Paul McManus / Lianne Cawthorne                  Mob: 07980 541 893 / 07584 391 303

This information is provided by RNS

The company news service from the London Stock Exchange

END

REAUWVSRWNASRAR

(END) Dow Jones Newswires

April 09, 2018 03:25 ET (07:25 GMT)

Ekf Diagnostics (LSE:EKF)
Historical Stock Chart
From Apr 2024 to May 2024 Click Here for more Ekf Diagnostics Charts.
Ekf Diagnostics (LSE:EKF)
Historical Stock Chart
From May 2023 to May 2024 Click Here for more Ekf Diagnostics Charts.