Whoever said beauty is only skin deep hasn’t looked below to see what Sientra Inc. has made available there recently. The medical aesthetics company now boasts the only tissue expander cleared in the U.S. for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients. Sientra’s CTO Denise Dajles told BioWorld the newly cleared Allox2 Pro Tissue Expander builds on the original expander also cleared by the FDA. “No other expander in the market has an MRI compatibility indication because they are based on a metal, i.e., metallic ports and big magnets in them,” Dajles explained.

IA Medical SAS raised $1.5 million to accelerate the development of its Alix chatbot, designed to support and make life easier for caregivers of patients suffering from Alzheimer's disease. The Klesia GIE investment fund, which depends on Agirc-Arrco GIE, the administrator of the French private-sector pension scheme, and the French sovereign bank BPIFrance SA contributed 46.42% of the financing. More than half of this financing corresponds to an opening of IA Medical SAS's capital to individual partners, including doctors.

General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode.

The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc., has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements.

Avenda Health Inc. reported new study results showing its Unfold AI platform, which uses artificial intelligence (AI) to map a tumor’s location within the prostate, encapsulates all of the clinically significant cancer present in the gland more effectively than standard care.

Beyond Air Inc. completed a senior secured debt financing of up to $40 million from Avenue Capital Group to support the company’s commercial launch of the Lungfit PH and further development of the Lungfit platform. Beyond Air is focused on applications of nitric oxide for the treatment of patients with a range of respiratory conditions. Its affiliate, Beyond Cancer Ltd., is developing a treatment for solid tumors that uses an ultra-high concentration of nitric oxide.