Feedback Regulatory News (FDBK)

Feedback plc

Bleepa® 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.

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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®, 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®, see www.bleepa.com.