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Technology will be announced after FDA Approval

Ovaera is on track to secure FDA 510(k) clearance in 2026 and execute a full U.S. commercial launch in 2027

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<h2 style="white-space:pre-line">Message from the Founder</h2>
<p>"Innovation in women’s health has been constrained by economics. Lower reimbursement has limited return on investment, slowing the development and adoption of new technology despite clear clinical need. Ovaera was built to change that dynamic.</p>
<p>The focus is simple: develop technology that performs at or above the current standard while improving cost. By eliminating unnecessary overhead and maintaining a fully U.S.-based supply chain, Ovaera is able to deliver high-quality devices with stronger economic value.</p>
<p>Every product under the Ovaera umbrella must be clinically meaningful and capable of improving both performance and cost. The approach is disciplined, starting with a single procedure and only expanding where both quality and economics can be meaningfully improved."</p>
<p style="text-align:left">- Abbie McClelland</p>

Ovaera Medtech

Ovaera Medtech is a U.S.-based medical device manufacturer dedicated to advancing innovation in women’s health. The company develops and manufactures gynecologic and urologic devices while building a nationwide, specialized distribution network to bring these products to physicians and patients. By partnering with startups and small firms, Ovaera pairs cutting‑edge technologies with an experienced, consultative salesforce focused on reproductive health, filling the gap that has limited market traction for women’s health innovations. As a domestic OEM, it improves, efficiently manufactures, and markets only technologies that offer a clear competitive advantage. The business is just starting out.