Medical device company profile

MALCOVA

Medical-imaging developer researching narrow-beam CT for breast imaging and related digital and physical tissue models.

Manufacturer / DeveloperDiagnostics & ImagingOncologyWomen’s & Reproductive HealthDiagnostic Imaging

Headquarters🇺🇸Newark, California, United States

Founded2020

Commercial statusIn developmentBreast-imaging platform in development; U.S. marketing authorization and routine clinical availability not established

Employees2–10 ^[11]LinkedIn company-size range · Checked 2026-10-20

Estimated revenueNot confirmed

Disclosed fundingUS$1.214 million ^[13]Amount sold · SEC filing Sep 2026

Official websitemalcova.com ↗

Company overview

MALCOVA develops narrow-beam computed tomography technology for breast imaging, including dense breast tissue. Its research platform also includes digital tissue models, physical imaging phantoms and AI-based visualization tools.

Co-founders Peymon Ghazi and Tara Ghazi lead the company. The company reports a 2020 founding date on LinkedIn; its 2026 SEC filing identifies Malcova, Inc. at a Newark, California business address. Research results and prototype demonstrations do not establish routine clinical availability or diagnostic superiority.

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Leadership

2 people

Peymon Ghazi, PhDCo-Founder & Chief Executive Officer ^[8]

Tara Ghazi, PhDCo-Founder & Chief Business Officer ^[8]

Products & regulatory status How does MedTechIndex get this information?

Summary

MALCOVA describes a development-stage breast-imaging platform and supporting tissue-model technologies. The completed company-name 510(k), De Novo and PMA searches did not identify a matching marketing decision; the Breast Monarc 510(k) query also returned no match. No claim of access to pending submissions is made. ^{[9][11][1][2][5][10]}

No matching FDA recall/enforcement record was identified under MALCOVA or in the selected Breast Monarc recall query. ^[4][3][6][7]

Regulatory snapshot How to read this snapshot

U.S. FDA

0
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Breast imaging

Narrow-Beam breast CT / Breast Monarc ↗

Investigational breast-imaging platform using narrow-beam CT. The company has described Breast Monarc prototype work; diagnostic performance claims are not independently established in this profile. ^[9][11]

Investigational / in development