EBR Systems Inc (ASX: EBR) shares were in the spotlight on Monday when the medical device company released some big news.

The ASX company revealed that it has received FDA approval for its WiSE CRT System, the world's first and only leadless cardiac resynchronisation therapy (CRT) system designed for heart failure patients who can't be treated using conventional methods.

It is clearly a huge milestone — but interestingly, its shares tumbled 17% to $1.40 on the news.

While that might sound strange, it could be a classic case of "buy the rumour, sell the news." Investors had likely priced in approval after months of positive momentum, with the stock still up more than 60% over the past 12 months.

Why this approval matters

Cardiac resynchronisation therapy is a proven treatment for heart failure, but many patients are excluded from receiving it due to anatomical challenges or previous complications with lead-based systems.

EBR's WiSE CRT System eliminates the need for those leads — instead offering a wireless, leadless pacing solution that works with existing pacemakers and defibrillators. The US FDA has now approved it for use in two high-need patient groups: those with previous failed lead implants and those deemed too high risk for traditional upgrades.

In short, EBR is now targeting a US$3.6 billion market opportunity — and that's just the beginning. The company plans to expand indications over time, potentially unlocking further upside.

What happens next for this ASX company?

While approval is now in hand, this ASX company isn't diving into full-scale commercialisation straight away.

The release notes that rollout will begin in late 2025 with a limited release, focused on hospitals that participated in prior clinical trials. A broader launch is expected in 2026, with infrastructure, training, and support being ramped up in parallel.

Importantly, management highlights that is also eligible for federal reimbursement support in the United States, which should help hospitals adopt the technology faster and reduce pricing friction. Post-approval studies involving 320 patients will be conducted over five years, as required by the FDA.

The ASX company's President & Chief Executive Officer, John McCutcheon, said:

We are thrilled to announce this major milestone for EBR and to share this achievement with our dedicated team, shareholders, partners and stakeholders who have supported us on this journey. Securing FDA approval for the WiSE CRT System is a transformative moment, marking our transition from clinical development to commercialisation.

With FDA approval in hand, EBR is well-positioned to bring our innovative solution to market, delivering real impact to patients and servicing a significant unmet need. We look forward to executing our commercial strategy and achieving our first revenue in late 2025, paving the way for sustained growth and long-term success.