The BLOOM⁴³ App is DHAF Assured for Quality and Safety
The BLOOM⁴³ app, a free digital companion for individuals preparing for and recovering from breast surgery, has officially been DHAF assured (Digital Health Assessment Framework) giving it accreditation with US Standards and regulatory requirements.
DHAF was developed between the American College of Physicians (ACP), American Telemedicine Association (ATA), and the Organization for the Review of Care and Health Apps (ORCHA) and is an open framework of 400 criteria, to support the identification and adoption of high-quality digital health technologies.
We are thrilled that the BLOOM⁴³ app meets DHAF's high standards for clinical assurance and safety; data and privacy; and usability and accessibility. This independent assurance of the BLOOM⁴³ app gives patients and clinicians alike trust and faith that our digital health app meets the best practice and standards making it safe in the hands of anyone that chooses to use it to support their breast surgery journey.
Created in collaboration with patients, BLOOM⁴³ was designed to answer the question so many face ahead of surgery: "What can I do to prepare?"
The app supports users whether or not they are using the FDA-registered BLOOM⁴³ device—the world’s first medical device designed to help patients safely precondition their skin at home before breast surgery. It offers clear, valuable, and empowering resources for every stage of the surgical journey.
“Exactly what I needed – I honestly breathed a sigh of relief when I opened the app. It was just what I needed post surgery. There is so much essential information, presented in a clear way, stopped me worrying or trying to get hold of the surgery team before I needed to. I would highly recommend to anyone about to have or post surgery.” – Becky, Patient
The BLOOM⁴³ app is available free to download globally on iOS and Android. Just search “BLOOM⁴³” in your app store.
About Plexāā
Plexāā is a pioneering UK MedTech company focused on improving surgical outcomes through innovative solutions. Their flagship device, BLOOM⁴³ enables patients to supraphysiologically precondition their skin, potentially reducing the risk of wound healing complications such as infection and skin necrosis, which affect 1 in 3 women undergoing breast surgery.
BLOOM⁴³ is the world’s first fully wearable device worn next to the skin before breast surgery. By gently warming the area to stimulate the release of Heat Shock Proteins (HSPs). These naturally occurring proteins cause the release of carbon monoxide into the tissue which vasodilates the blood vessels and improves the blood flow to the skin. This improved blood flow primes the skin to heal and has been shown to prevent wound healing complications in proof-of-concept clinical trials.
Plexāā is also exploring the application of this technology in other surgical fields, including obstetrics for C-sections, orthopedics for joint operations, and general and vascular surgery, with a commitment to improving pre-operative preparation for surgery and patient outcomes.
Media Contact: