AMF Medical and Sensars receive FDA Breakthrough Device Designation

AMF Medical’s Sigi pump can be programmed to deliver basal and bolus insulin at both set and variable rates. In addition, as an Alternate Controller Enabled-pump, it is able to receive, execute and confirm dosing commands by interacting with Bluetooth-compatible, continuous glucose monitors and alternate controller devices, like a smartphone or an iController.

“Clinical study data has shown that Sigi is delightfully easy to use. Study patients have expressed satisfaction as well as eagerness for this next generation patch to be readily available.  We are pleased that the FDA also sees its clear value and is moving the process forward,” said Professor A. Wojtusciszyn, MD, PhD from Lausanne University Hospital (CHUV) and principal investigator of the first Sigi clinical study.

AMF Medical Co-CEO & Co-Founder Antoine Barraud said, “We would like to thank the FDA for recognizing our team’s proprietary, patient-focused technology, which provides users with enhanced clinical and convenience features.  This Breakthrough Device Designation will expedite the development of Sigi and prioritize its review in future FDA regulatory submissions.  It is a huge step forward in bringing Sigi to market to improve insulin management.”

SensArs has also been granted FDA Breakthrough Device Designation for SENSY. Through its novel implantable stimulator, SensArs’ innovative technology elicits natural sensations of touch and movement that have been shown to effectively treat chronic neuropathic pain and reduce movement disability due to sensory loss. “This is a huge step towards SensArs’ mission of bringing relief to those suffering from chronic peripheral neuropathic pain and/or sensory loss”, comments the team in a blog post.

(Press release / SK)