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Saturday, September 5, 2026
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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 // GI & Urology

GI & Urology

Endoscopy, incontinence, kidney and gastrointestinal devices. 10 companies listed.

Houston, TX  ·  Est. 2016  ·  Acquired

Makes a stimulation device surgeons use to make the ureter and other smooth muscle structures move so they can be identified during surgery. Acquired by Northgate Technologies in April 2023.

Natick, MA  ·  Est. 2009  ·  Public  ·  PMA approved

Allurion makes a swallowable gastric balloon that needs no endoscopy or anesthesia and passes on its own after about four months. It pairs the balloon with a remote care app and scale.

South San Francisco, CA  ·  Est. 2023  ·  Unknown

Developing surgical robots that add AI guidance during procedures, starting with prostate surgery.

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.

Denver, CO  ·  Unknown  ·  PMA approved

Develops blood tests that quantify liver function from cholate clearance to stage liver disease and guide varices screening. Runs its own CLIA laboratory in Colorado.

Melbourne, Australia  ·  Est. 2018  ·  Unknown

Builds software based therapeutics delivered through healthcare providers for gastrointestinal conditions such as irritable bowel syndrome.

Dublin, Ireland  ·  Est. 2015  ·  Series B  ·  PMA approved

ProVerum makes the ProVee System, a removable nitinol expander for the prostatic urethra that relieves BPH symptoms without cutting or heating tissue. It spun out of Trinity College Dublin.

San Clemente, CA  ·  Est. 2015  ·  Acquired

Developed the Connected Catheter, an indwelling catheter for men managing neurogenic bladder after spinal cord injury.

San Carlos, CA  ·  Series A  ·  Submission pending

Ventaris Surgical is developing a ureteroscopic system for kidney stone removal designed to achieve complete stone clearance in one procedure.

San Francisco, CA  ·  Est. 2014  ·  Unknown  ·  PMA approved

Developing the Zenflow Spring, an implant placed during an office based urology procedure to relieve urinary obstruction from benign prostatic hyperplasia.

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