Saliva-Based Family Planning Tech Approved

A Berlin-based health tech company has received official European approval for its at-home saliva fertility tracker to be marketed as a certified contraceptive device, a first of its kind.

From Fertility Tracker to Certified Contraceptive

The product in question, called the Minilab, was developed by Inne, a women’s health startup founded by entrepreneur Eirini Rapti. Until now, the Minilab has been used primarily as a tool for tracking fertility and menstrual cycles, marketed to women trying to conceive. However, following a clinical trial and regulatory review, the device has now been certified as a medical contraceptive across Europe.

BSI

The approval came from the British Standards Institution (BSI), one of Europe’s major medical device certifiers, and paves the way for the Minilab’s roll-out across the EU, starting in Germany and Austria, with UK availability expected later this year.

An Effective Hormone-Free Alternative

What sets the Minilab apart is that it is non-invasive, hormone-free and digital-first. For example, instead of using oestrogen or progestin to suppress ovulation, or inserting physical devices like IUDs, the Minilab works by measuring a key reproductive hormone (i.e. progesterone) in saliva, thereby offering a precise read of a woman’s cycle in real time.

100% Effective In Study

A one-year study involving 300 women across 1,467 cycles found the method to be 100 per cent effective with perfect use, meaning no unprotected sex during the identified fertile window, and 92 per cent effective under typical use conditions. That puts it in line with the combined contraceptive pill (99 per cent perfect use, 93 per cent typical) and more effective than condoms (98 per cent perfect, 87 per cent typical), according to NHS data.

Caveat

However, it’s worth noting that the study was observational, relatively small, and not peer-reviewed, meaning further validation will be needed over time to bolster long-term trust.

The Science Behind the Saliva

In terms of the science behind it, the Minilab uses a lateral flow assay (a test format similar to COVID-19 and pregnancy tests) in combination with antibodies that react to progesterone. Each morning, users deposit a small amount of saliva on a test strip, which is then inserted into a pocket-sized electronic reader. Over 10 minutes, the device photographs and analyses how hormone particles move along the strip.

Companion App

The data is processed using image recognition and biochemistry algorithms, then synced with a companion app. The app displays hormone levels, indicates the user’s current fertility status, and highlights “high probability” days for pregnancy risk.

According to Rapti, this offers a more accurate and personalised experience than alternatives such as temperature-based methods (used by competitors like Natural Cycles) or calendar-based period tracking apps.

“Temperature can be affected by illness, disrupted sleep, or alcohol,” she explained (in an interview with Euronews Health). “Saliva gives you direct insight into hormonal changes — it’s biological data, not pattern recognition.”

Who Can Use It And Who Can’t?

While Inne is pitching the Minilab as a more comfortable and flexible method, it isn’t suitable for everyone. The company only recommends it for women who:

– Are over 18.

– Are not currently pregnant or breastfeeding.

– Have regular menstrual cycles (22 to 35 days).

– Are not taking hormonal contraceptives or other hormone-altering treatments.

– Have completed at least two full menstrual cycles after stopping hormonal contraception, pregnancy, or breastfeeding.

Flexible Test Window

The test window is flexible, allowing women to take it within a four-hour period each day, and everyday influences like minor illness, sleep quality, or alcohol consumption don’t affect the saliva readings, according to Inne.

Subscription-Only (For Now)

For now, the Minilab is available on a subscription basis, starting at €24 per month when paid upfront for two years. The device is already covered by Germany’s largest public health insurer, and the company is in discussions to expand insurance coverage to more markets.

A Sign of the Times in FemTech

Inne’s move into contraception could be said to reflect a broader trend in femtech, i.e., the intersection of digital health and women’s wellbeing, where user demand for hormone-free alternatives is growing. Apps like Natural Cycles and wearables like Daysy have gained traction, but most still rely on indirect indicators like temperature or physical symptoms.

Several other companies are also innovating in this space. Natural Cycles, based in Sweden, remains the most established, offering an app-based contraceptive approved by EU regulators and the US FDA, which relies on temperature readings and cycle tracking. US-based Oova uses urine hormone testing paired with an AI-driven app to support both conception and cycle tracking, while Mira offers a home hormone analyser that measures luteinising hormone (LH) and oestrogen metabolites using urine samples. Though not currently certified as contraceptives, these tools reflect a growing shift toward bio-data driven reproductive management.

Minilab’s focus on hormone measurement aims to make fertility awareness methods, which have long been viewed as unreliable, scientifically robust and medically certified. Also, unlike blood hormone tests, saliva offers a non-invasive, low-cost, and scalable home testing method.

“We are excited and proud to offer women a modern, safe, and hormone-free method that enables them to take charge of all aspects of their fertility,” said Eirini Rapti, Inne’s founder and CEO, in a statement on the company’s website. “This includes conception support, cycle tracking, and now — contraception.”

Not Without Its Limits

Despite the innovation, Inne’s Minilab is not a silver bullet. For example, the clinical study behind its certification has not been peer-reviewed and included only around 300 participants, which is a far cry from the multi-year, tens-of-thousands scale typically used to validate pharmaceutical contraceptives. There was also no control group to rule out behavioural bias.

It’s also worth noting here that like other fertility awareness methods, the device requires consistent, disciplined use, especially around the fertile window. While “perfect use” returned zero unintended pregnancies in the study, real-life adherence may prove more challenging.

As the Pearl Index for typical use (7.98) indicates, up to 8 in 100 women may still become pregnant annually which is something that regulators and healthcare providers will need to communicate clearly as adoption expands.

A Regulatory and Approval Milestone

For Inne, regulatory approval marks a major milestone in a mission to reshape reproductive health. It opens doors for reimbursement discussions, partnerships with public health bodies, and a foothold in the lucrative digital contraception market.

However, it also sets a precedent for other non-invasive, hormone-free technologies to follow. Natural Cycles, which became the first certified app-based contraceptive in 2017, paved the way for digital fertility solutions. Inne now adds a saliva-based dimension that could push the sector further toward precision diagnostics and preventative care.

Plans To Track Other Hormones

It seems that plans are already underway to extend the Minilab platform to track additional hormones like cortisol and testosterone, which could unlock applications in stress management, athletic performance, and broader hormone health.

A New Category?

As women increasingly demand options that are accurate, private, non-invasive, and side-effect free, regulators and insurers may be forced to rethink how they categorise and fund digital tools that sit between medicine, lifestyle, and health tech.

What Does This Mean For Your Business?

The regulatory approval of Inne’s Minilab not only introduces a new contraceptive option but also opens up a fresh category of health technology, i.e. one that blends medical-grade diagnostics with consumer-friendly usability. For women seeking hormone-free, side-effect-free alternatives, the Minilab represents a significant step forward in personalised reproductive care. Its arrival could prompt greater scrutiny of conventional methods and accelerate demand for more individualised solutions that place data and agency directly in users’ hands.

For healthcare professionals and regulators, the challenge now is how to support innovation without lowering the bar for safety and efficacy. The Minilab may be CE-certified, but the supporting evidence is still limited in size and scope. That means clear communication with users will be vital. Transparency around what “perfect use” actually requires, and how the device should and should not be used, will need to be prioritised across clinical guidance, marketing, and insurance frameworks.

UK businesses working in health tech, diagnostics, and femtech could see this as a signal to act. With the UK still aligning with many EU medical device regulations post-Brexit, and the BSI playing a dual role in both jurisdictions, there is a clear route to market for British innovators who can offer similarly precise, non-invasive, and hormone-free products. Private healthcare providers and employers may also begin to consider partnerships with platforms like Inne as part of wider wellbeing packages, particularly for staff cohorts seeking natural and flexible contraception options.

It seems that the wider digital contraception space is now under pressure to raise its own standards. While apps based on temperature or calendar data were once seen as disruptive, they now face competition from tools offering real-time biological insight. Saliva testing brings a new level of scientific grounding that could redefine what qualifies as reliable cycle tracking, especially as consumer expectations rise.

Inne may have been the first to gain certification for a saliva-based contraceptive, but it is unlikely to be the last. What happens next will depend on continued evidence, smart regulation, and how successfully these tools can prove their value not just in lab settings, but in the unpredictable realities of everyday life.