Feedback PLC - Bleepa® achieves CE Mark
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
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
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.
"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.
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
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
Real world feedback forms an essential component of CE accreditation and the deployment at
| || |
+44 (0)1954 718072
| || |
+44 (0)20 3328 5656
| || |
+44 (0)20 7469 0936
| || |
+44 20 3815 8880
| || |
+44 (0)20 7457 2020
+44 7890 022 814
Notes to editors
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.
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.
This information is provided by RNS, the news service of the
Quick facts: Feedback PLC
Market Cap: £11.2 m
NO INVESTMENT ADVICE
The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...FOR OUR FULL DISCLAIMER CLICK HERE