It's not often that a company in the medical device industry, where most new products offer incremental innovation, has a chance to change the world. Start-up GI Dynamics does, though. Shooting for a non-invasive device that would replicate some of the benefits of the invasive Roux-en-Y gastric bypass surgery in obesity, it discovered that an endoscopically delivered implant appears to be extremely effective in type 2 diabetes, as is the predicate gastric bypass. Simple and non-invasive, the technology is potentially disruptive by reversing the disease, not just managing its symptoms. (See also the sidebar to this article: "A Mechanistic Look at Diabetes Surgery: An Interview with Francesco Rubino." )
By Mary Stuart
It’s not often that a company in the medical device industry, where most new products offer incremental innovation, has a...
Join thousands of industry professionals who rely on In Vivo for daily insights
Already a subscriber?
As gene therapy advances and regulations tighten, biopharma companies face growing pressure to design diagnostic assays that are both flexible and future ready. Strategic early investment in assay development can prevent costly delays and rework as therapies progress toward approval.
Pharma leaders are shifting from AI pilots to enterprise-scale deployment, favoring external partnerships for efficiency gains while maintaining tight control over sensitive clinical data.
IMMA’s transvaginal at-home ovarian stimulation monitoring system using ultrasound and AI image analysis increases the chances of early IVF success. It won the Biomed Israel 2025 IVD start-up showcase award. Further potential applications could follow, cofounder/CEO Beatrice Chemla told In Vivo.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
Lonza is addressing the growing global demand for biologics by utilizing its expert teams and the advanced capabilities of its newly acquired large-scale manufacturing site in Vacaville, California. Joanna McCafferty, Director of Commercial Development, shares more in this brief video. Ask ChatG
Understand who’s influencing access decisions and how pharma can engage strategically across the continent.
Pharma leaders are shifting from AI pilots to enterprise-scale deployment, favoring external partnerships for efficiency gains while maintaining tight control over sensitive clinical data.
