A smart insole developed by Austrian company Stappone is now listed with the US Food and Drug Administration, and the software behind it was built by South African engineering firm Octoco.

The FDA listing as a 510(k)-exempt Class II medical device means clinics, medical practices and physical therapists in the United States can now use the system. Octoco built the software platform that connects the insoles to apps for patients, practitioners and administrators.

The stappone insole has pressure sensors built into it. As a person walks, it measures how the foot is loaded with every step and shows the results live on a phone or tablet, including how long each foot is on the ground, step length, cadence and where pressure peaks.

That gives therapists, podiatrists and orthopaedic specialists an objective measurement instead of a judgement by eye, and it works in the clinic, on a treadmill or during normal walking. Stappone says it is already used in European clinics, and its patented technology has uses in orthopaedic rehabilitation, sport, and research into conditions that affect movement.

The FDA listing is the gateway to the US market. Many medical devices must go through a review process, called a 510(k), to show they are as safe as devices already on sale. For some well-understood categories, the FDA waives that requirement.

Stappone chose to work closely with the FDA and go through the full process anyway, and its reviewer confirmed in writing that the device qualifies as exempt, so it could register directly. Stappone credits Maria Schwarzinger, who led its regulatory work.

Depending on the insurer, US treatments using the device may be reimbursable through remote monitoring, biofeedback or therapy billing codes.

Stappone's announcement describes the device as proven in European clinics and now ready for the world's largest healthcare market. Founder and chief executive Peter Krimmer explains in a video why the company chose to work so closely with the FDA. Octoco said on LinkedIn that the system replaces costly one-off assessments in specialised gait labs with continuous, real-world data that tracks how a person's walking changes over time.

For Octoco, this is a strong credential. Its software now sits inside a device cleared for use in US clinics, one of the hardest markets in the world to enter, and that kind of track record is what international clients look for when choosing an engineering partner for regulated products.

It also adds to Octoco's growing presence in serious industrial and health technology, after it took a stake in HisWay Labs, the rail sensor company certified by PRASA. It is a useful reminder for local founders and engineering firms that South African teams can build the core technology for products sold in the most demanding markets, as BioInformatiCo's clinical trial platform showed too.

Stappone's own path holds a lesson as well: instead of assuming it qualified for an exemption, it went through the process and got the answer in writing, which gives its US customers more confidence.

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