Women’s health wearable company Emm has secured UKCA marking and MHRA registration for the Emm Cup, which the company says is the world’s first regulatory-cleared smart menstrual cup.

The Emm Cup is designed to passively measure menstrual flow volume, daily flow rates and broader cycle patterns, replacing manual tracking and personal estimates with objective biometric data.

The device syncs with a smartphone app when placed in its charging case, allowing users to monitor changes over time and share the information with healthcare professionals.

“UKCA marking validates our technology requirements and opens the door for millions of people to truly know their health today and screen for their health tomorrow,” said Jenny Button, Founder and CEO of Emm.

Towards objective measurement

The milestone reflects a broader shift towards bringing objective measurement to areas of women’s health that have historically relied on subjective symptom reporting.

Menstrual health has traditionally depended on patients recalling information such as cycle length or estimating whether bleeding is ‘light’ or ‘heavy’. Technologies such as the Emm Cup aim to replace those subjective assessments with measurable physiological data that can be tracked over time and shared with clinicians.

“For too long, a critical data gap in women’s health has led to delayed diagnoses and the routine dismissal of pain,” continued Jenny. “We believe our technology can act as a catalyst to unlock some of the world’s least understood reproductive health challenges, turning subjective symptoms into objective, actionable data.”

Following UK regulatory clearance, Emm said it is pursuing US FDA clearance and ISO 13485 certification as it prepares for an international rollout.

Emm secures UK regulatory clearance for smart…