Innoblative

Innoblative, a private medical device company addressing clinical unmet needs for patients with breast cancer and other soft tissue disease, received Breakthrough Device Designation from the FDA for the company's SIRA™ RFA Electrosurgical Device (SIRA). The SIRA device is intended for use in breast cancer patients undergoing BCS, commonly referred to as lumpectomy. Innoblative's SIRA™ device has a unique spherical shape to the entire cavity that circumferentially delivers RF energy and yields reproducible ablation depths to provide greater confidence of a consistent thermal effect.

What we delivered:

• Design verification support & test protocols

• Design Root Cause Analysis

• Hands-on clinical device testing support

• 510(k) application documentation support