Pulsenmore Expands into Fertility Care: Completes CE European Registration of Home Ultrasound System for Follicular Monitoring
Pulsenmore Ltd. (Nasdaq: PLSM) (TASE: PLSM) has completed CE European registration for its home ultrasound system, Pulsenmore FC, expanding into fertility care. The system allows patients to perform scans at home, reducing clinic visits. Over 1.15 million assisted reproduction treatment cycles were reported in Europe in 2023, with many requiring repeated ultrasounds. The company aims to market the system across Europe, following approval in Israel and a commercial agreement with Clalit Health Se
How this was made

The 30-second read
Why it matters
The EU MDR registration is a material corporate milestone, opening a new revenue stream and potentially boosting the stock.
Market read
First‑time EU clearance for a fertility‑care ultrasound device; could drive stock re‑rating.
What to watch
Reimbursement policies and competition from established imaging companies may constrain growth.
Background
Pulsenmore, a Nasdaq‑listed med‑tech company, previously focused on prenatal monitoring and now expands into fertility care with a CE‑marked home ultrasound system.
Ticker impact
Pulsenmore completed European MDR registration for its home ultrasound fertility care system, enabling sales across Europe.
Potential upside as investors price in European market expansion.
First disclosure of EU registration; no prior public announcement, but scale is limited to a niche medical device.
Market effects
May spur interest in home‑ultrasound and digital health firms targeting women's health.
European fertility clinics could adopt the technology, increasing demand for related services.
Highlights trend toward remote diagnostics, relevant to med‑tech investors worldwide.
Counterpoint
Adoption could be slower due to regulatory nuances and clinician acceptance, limiting near‑term upside.
Key entities
- CompanyPulsenmore Ltd.
Developer of self‑use ultrasound devices, listed on Nasdaq (PLSM).
- PartnerClalit Health Services
Israeli health insurer partnering with Pulsenmore for commercial rollout.

