TheraRadar
Data updated: May 26, 2026

PULMOTECH MAA (technetium tc99m albumin aggregated)

Respiratory Approved 2020-03-20

Pulmotech MAA is a radioactive diagnostic agent used in medical imaging procedures for both adult and pediatric patients. After radiolabeling with technetium-99m, the agent is utilized as an adjunct in lung scintigraphy to evaluate pulmonary perfusion. In adult populations, it is also indicated for use in peritoneovenous shunt scintigraphy to assist in the assessment of shunt patency.

Source: FDA Label • CIS BIO INTL

How PULMOTECH MAA Works

Following intravenous injection, more than 90 percent of the technetium Tc 99m albumin aggregated particles are trapped within the arterioles and capillaries of the lungs. For shunt evaluation, the agent is administered intraperitoneally where it mixes with peritoneal fluid. The rate at which the agent clears from the peritoneal cavity and enters systemic circulation indicates whether the peritoneovenous shunt is patent or blocked.

1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2020-03-20
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

PULMOTECH MAA Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2020 to 2023
Aug 2023 SUPPL
Label · Labeling
Mar 2020 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What PULMOTECH MAA Treats

2 indications

PULMOTECH MAA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lung scintigraphy for pulmonary perfusion evaluation
  • Peritoneovenous shunt scintigraphy for patency evaluation
Source: FDA Label

PULMOTECH MAA Competitive Set

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Indication competitors

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Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PULMOTECH MAA FDA Label Details

Indications & Usage

FDA Label (PDF)

PULMOTECH MAA is indicated for the treatment of Lung scintigraphy for pulmonary perfusion evaluation; Peritoneovenous shunt scintigraphy for patency evaluation.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.