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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Directory // Diabetes & Metabolic

Diabetes & Metabolic

CGM, insulin delivery and metabolic monitoring. 2 companies listed.

Endogenex

Minneapolis, MN · Est. 2017 · Series C · Breakthrough designation

Develops ReCET, an endoscopic catheter that applies non-thermal pulsed electric fields to the duodenum to treat type 2 diabetes. Breakthrough-designated and in a randomized, sham-controlled IDE study.

Profile →www.endogenex.com ↗

UpDoc

Mountain View, CA · Seed · $18M raised · 510(k) cleared

UpDoc makes prescription software that collects diabetes data from patients through a voice and chat agent. It issues insulin dosing instructions within parameters set by the prescriber.

Profile →updoc.ai ↗