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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

510(k)

Bunkerhill Health lands seventh 510(k) with first AI for mitral annular calcification

MedDevice Startups Staff · Oct 8 · 2 min read · Via Bunkerhill Health release (PR Newswire)

FDA cleared Bunkerhill MAC on October 3 under K250662. The San Francisco company says it is the first AI algorithm cleared to detect and quantify mitral annular calcification on routine, non-gated chest CT. FDA received the submission on March 5, a 212-day review under product code JAK.

The algorithm runs on chest CTs ordered for other reasons and flags calcium in the ring of the mitral valve. That finding is tied to valve disease and stroke risk. Data for the clearance came from seven consortium sites, among them Emory, Thomas Jefferson University and UCSF. Bunkerhill ships it through its Carebricks platform next to its other cleared models.

Founded in 2019 by Nishith Khandwala and David Eng, the company has now logged seven 510(k)s since April 2023, per openFDA. Its ECG-EF algorithm cleared on September 19 under K250649, two weeks before MAC. Two clearances in 14 days is what a repeatable submission process looks like once the quality system and predicate strategy are settled.

Questions & Answers

What did FDA clear under K250662?

K250662 is the 510(k) for Bunkerhill MAC, cleared October 3, 2025 under product code JAK. The software detects and quantifies mitral annular calcification on routine, non-gated chest CT scans.

How many FDA clearances does Bunkerhill Health have?

Bunkerhill MAC was Bunkerhill Health's seventh 510(k) since April 2023, according to openFDA. Its ECG-EF algorithm cleared two weeks earlier, on September 19, 2025, under K250649.

Who founded Bunkerhill Health?

Bunkerhill Health was founded in 2019 by Nishith Khandwala, who is CEO, and David Eng. It is based in San Francisco.

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