The BLOOM⁴³ App ORCHA Assured for Quality and Safety
The BLOOM⁴³ app, a free digital companion for individuals preparing for and recovering from breast surgery, has officially been ORCHA assured (Organisation for the Review of Care and Health Apps)—marking a major achievement in digital health.
Following a rigorous evaluation against over 350 global standards, the BLOOM⁴³ app was reviewed for clinical assurance, data privacy, and usability. The result: confirmation that it meets ORCHA’s high standards for safety, effectiveness, and quality.
"At ORCHA, we assess thousands of health apps every year, and only a small percentage meet the high standards required for verification. BLOOM⁴³’s achievement reflects a deep commitment to quality, safety, and real patient value." — Liz Ashall-Payne, Founder ORCHA
Only around 20% of health apps reviewed by ORCHA achieve ORCHA assurance. In the U.S., of over 4,000 health apps evaluated, just 15% met the necessary healthcare, security, or usability criteria—making this a remarkable milestone for the BLOOM⁴³ app.
This assurance opens the door for BLOOM⁴³ to be listed across ORCHAs distribution environments, including the many NHS App Libraries across the UK, positioning it among a trusted group of digital health tools that patients and clinicians can rely on with confidence.
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.
Carly Moosah, patient champion at Plexaa and breast cancer survivor, shared: "As someone who went through a double mastectomy, I felt completely overwhelmed trying to find reliable information and understand my reconstruction options. Knowing an app like BLOOM⁴³ is ORCHA assured would have made a world of difference. It’s something I would have trusted—something that could have empowered me when I felt most vulnerable. I hope it gives that sense of control and reassurance to every patient who downloads it."
The BLOOM⁴³ app is now 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: