WHERE ARE YOU?

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 / Imaging & Radiology

Imaging & Radiology Cardiovascular Digital Health & SaMD

Bunkerhill Health

San Francisco, CA · Series B · 510(k) cleared

Bunkerhill Health develops FDA-cleared AI algorithms that find cardiovascular and bone disease on imaging and ECGs ordered for other reasons. Hospitals run them through its Carebricks platform.

FDA DECISIONS ON FILE

4 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 6, 26	K260166510(k)	Bunkerhill Contrast CAC	BunkerHill Health	Radiology	JAK
Mar 6, 26	K260167510(k)	Bunkerhill Contrast AVC	BunkerHill Health	Radiology	JAK
Oct 3, 25	K250662510(k)	Bunkerhill MAC	BunkerHill Health	Radiology	JAK
Sep 19, 25	K250649510(k)	Bunkerhill ECG-EF	BunkerHill Health	Cardiovascular	QYE

← More Imaging & Radiology startups

Bunkerhill Health

FDA DECISIONS ON FILE

COVERAGE