Feedback PLC Bleepa(R) achieves CE Mark (4523O)
June 01 2020 - 1:00AM
UK Regulatory
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RNS Number : 4523O
Feedback PLC
01 June 2020
Feedback plc
Bleepa (R) achieves CE Mark, raising the bar for medical
communication platforms
-- CE mark confirms use of Bleepa as a Class 1 Medical Device
-- The Directors of Feedback believe Bleepa is the only
communication platform to address the UK market that has met MDD
certification requirements
London, 01 June 2020: Feedback plc (AIM: FDBK, "Feedback" or the
"Company"), the specialist medical imaging technology company,
announces that, in compliance with the Medical Device Directive
("MD Directive") and having met the stringent criteria associated
with the manufacture of a medical device, it has affixed a CE Mark
to Bleepa. Bleepa is Feedback's flagship imaging-based
communication platform for clinicians to access medical grade
images through smartphones, tablets and desktops.
All clinical communication platforms that display digital images
of patients for the purpose of diagnosis are classed as medical
devices under the MD Directive guidelines and require a CE mark.
The Directors of Feedback believe that Bleepa is the only
communication platform to address the UK market that has met MD
Directive certification requirements.
The Directors also believe that having a CE mark is a major step
forward for the Bleepa product since the use of a non-CE marked
product inappropriately may put individual clinicians and Trusts at
risk of civil claims for damages arising from misuse of that
product. For this reason the Medicines & Healthcare products
Regulatory Agency ("MHRA") advise that all providers only use
appropriately CE marked devices.
Dr Tom Oakley, CEO of Feedback, commented:
"We believe that Bleepa is the future for communicating about
patient care and is already changing the way in which clinicians
discuss cases and process patients through the hospital system. The
CE mark is an important milestone in its commercialisation and sets
Feedback apart from other providers.
"Pennine Acute Hospitals NHS Trust and Royal Papworth Hospital
NHS Foundation Trust are both demonstrating the value of using
Bleepa across the hospital setting. This important regulatory
milestone offers healthcare providers confidence in our product
over other unregulated providers as we continue the roll-out of
Bleepa in support of the NHS, both to support the fight against
COVID-19 as well in day-to-day patient management."
Under MD Directive guidelines MedDev 2.1/6, any product that
acts as an image viewer with functionality for diagnosis based on
digital images may be classified as a medical device. Any
communication platform being used by clinicians to display digital
patient images as part of case discussion meets this stipulation
and are classified as a medical device under the MD Directive.
Under EU and UK law, CE marking is mandatory and manufacturers must
ensure the product bears CE marking if such product comes under the
scope of a directive requiring CE Marking.
Clinicians and hospitals are advised by the MHRA to use medical
devices with a CE mark, as this shows the device has met the legal
requirements for safety, quality and performance when it is used as
the manufacturer instructs. The MHRA further advises that off-label
use of a device, such as use of a device that does not carry an
appropriate CE mark will be at such user's own risk and such person
or their employer could become liable for civil claims for damages
from injured patients or their families if something goes wrong
with the device.
The Directors of Feedback ("the Directors") believe that Bleepa
is the only communication platform combining imaging and instant
messaging to address the UK market that has certified its
compliance with the MD Directive and is therefore legally able to
market itself as having image display capabilities. The CE Mark
Technical File defines the use case for Bleepa and provides
protection not only for the hospital Trust but also for the
individual clinician using the app, which the Directors believe
will make Bleepa the clinical communications tool of choice.
Dr Oakley added: "We believe that many NHS sites are unknowingly
using uncertified tools and are therefore exposed to civil claims
arising from use of those tools. Bleepa will enable Trusts to
engage the digital communication revolution safely and securely
within a regulated environment. Ensuring the roll out of a
regulated communication platform should be a key priority for the
NHS in its efforts to combat COVID-19 and beyond. Bleepa is now
uniquely positioned to deliver against this need."
Real world feedback forms an essential component of CE
accreditation and the deployment at Pennine Hospitals NHS Trust not
only generated the required clinical feedback but additionally led
to improvements in the product that have been incorporated into the
CE marked version of Bleepa. The CE marked version of Bleepa will
now be deployed at Royal Papworth Hospital as Feedback's second NHS
site.
-Ends-
Enquiries:
Feedback plc +44 (0)1954 718072
Tom Oakley, CEO IR@fbk.com
Lindsay Melvin, CFO
Allenby Capital Limited (Nominated Adviser)
David Worlidge / Asha Chotai +44 (0)20 3328 5656
Peterhouse Capital Limited (Joint Broker)
Lucy Williams / Duncan Vasey +44 (0)20 7469 0936
Stanford Capital Partners Limited (Joint
Broker)
Patrick Claridge / John Howes +44 20 3815 8880
Instinctif Partners +44 (0)20 7457 2020
Melanie Toyne-Sewell / Phillip Marriage +44 7890 022 814
feedbackplc@instinctif.com
Notes to editors
About Bleepa
Bleepa provides instant and remote access to clinical grade
medical images through a zero footprint application. The majority
of patient cases require medical imaging which can be seamlessly
shared to the entire clinical team through Bleepa. Cases can be
discussed through its secure instant messaging and image
annotation, allowing comments and treatment decisions to be
communicated instantly between team members. Bleepa can be accessed
from any internet connected device including phones, tablets,
laptops and desktops; clinicians can use their own devices and
therefore no additional hardware is required.
About Feedback plc - www.fbk.com
Feedback plc (AIM: FDBK) is a specialist medical imaging
technology company providing innovative software and systems,
through its fully-owned trading subsidiary, Feedback Medical
Limited. Its products advance the work of radiologists, clinicians
and medical researchers by improving workflows and giving unique
insights into diseases, particularly cancer.
Feedback has launched Bleepa (R) , a new secure, encrypted
medical communication app for clinicians accessible through
smartphones, tablets and desktops that facilitates rapid clinical
messaging and review of medical grade imaging for all members of a
clinical team, directly from a hospital Picture Archiving and
Communications System (PACS). For more information on Bleepa (R) ,
see www.bleepa.com .
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END
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