Feedback PLC Progress with CE Mark and trading update (4844F)
May 18 2017 - 1:01AM
UK Regulatory
TIDMFDBK
RNS Number : 4844F
Feedback PLC
18 May 2017
18 May 2017
Feedback plc
("Feedback", the "Group" or the "Company")
Progress with CE mark and trading update
Feedback plc (AIM: FDBK), the medical imaging software company,
is pleased to update shareholders on obtaining the CE Mark for
TexRAD. The Group had previously announced its expectation of
obtaining the CE mark for TexRAD Lung by a target date of end May
2017. In the course of development and review in compliance with
ISO 13485:2016, enhancements have been identified which will
improve the performance of this version of TexRAD and which will
assist in the progression of future versions to wider clinical
usage. The introduction of these modifications will result in a
delay of several weeks before the CE Mark for TexRAD Lung is
obtained. This is not expected to have any effect on the commercial
negotiations which are underway or on future sales of TexRAD.
The CE mark will allow the sale of TexRAD Lung in the EU and
certain other markets as a medical device that provides analysis of
PET/CT images of lung cancer for clinical use. As previously
announced, Feedback's subsidiary company, Cambridge Computed
Imaging Ltd ("CCI"), has signed a Letter of Intent with a leading
global medical imaging company which would make TexRAD Lung
available for purchase on its diagnostic imaging solutions
platform. The schedule for release on this platform remains
unaffected.
CCI continues to pursue its ongoing discussions with other
leading imaging companies to broaden the range of potential routes
to market for clinical versions of TexRAD. The funds raised from
the recent placing have enabled the Company to initiate recruitment
for business development and customer relations positions as well
as scaling up the software development collaboration with Future
Processing.
Note on CE Marking
CE marking is a claim by a medical device manufacturer that a
product meets the essential requirements of relevant Medical Device
Directives, which outline the safety and performance requirements
for medical devices in the EU. CE marking (and compliance with the
directives) is legally required before placing a device on the
market in the EU. CCI has obtained certification to ISO 13485, the
International Standard relating to quality management systems for
organisations involved in the manufacture of medical devices. An
appropriate quality management system and the preparation of a
technical file are requirements for CE marking. The CE technical
file is a comprehensive description of the device intended to
demonstrate compliance with the Medical Device Directives and
contains extensive documentation on the use, design, risk
assessment, testing, clinical evaluation and manufacture of the
device.
For further information contact:
Feedback plc Tel: 01954 718072
Alastair Riddell
Allenby Capital Limited (Nominated Tel: 020 3328
Adviser and Joint Broker) 5656
David Worlidge / Virginia Bull/
James Thomas
Northland Capital Partners Ltd (Joint Tel: 020 3861
Broker) 6625
Patrick Claridge / Margarita Mitropoulou
Peterhouse Corporate Finance Ltd Tel: 020 7469
(Joint Broker) 0936
Lucy Williams / Duncan Vasey
This information is provided by RNS
The company news service from the London Stock Exchange
END
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