Lung Bioengineering, Inc.: PMA approval for LungFX device
Lung Bioengineering, Inc. (Silver Spring, Maryland): PMA approval for LungFX device. Dated 135 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 8 related MD FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Lung Bioengineering, Inc. |
| Product | LungFX device |
| Generic / ingredient | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Approval | PMA original approval (new class III device) |
| Application | P240033 |
| Decided | 2026-06-22 |
| Panel / class | Gastroenterology, Urology |
| Sponsor location | Silver Spring, MD |
| Peer records CSV (9 MD records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-06-22
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Lung Bioengineering, Inc. and 9 Maryland peers
- Maryland FdaApprovalPulse records like this one: 9
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Maryland peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for Lung Bioengineering, Inc. in Silver Spring, Maryland?
The FDA approved LungFX device (P240033) for Lung Bioengineering, Inc. on 2026-06-22: PMA original approval (new class iii device).
How does Lung Bioengineering, Inc. compare to other Maryland FdaApprovalPulse records?
It is 135 days old; check the official source for later updates before acting.
Lung Bioengineering, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Lung Bioengineering, Inc. | Silver Spring, MD | 2026-06-22 |
| Vivasure Medical , Ltd. | Galway | 2026-10-16 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| Rejoni, Inc. | Bedford, MA | 2026-09-28 |
Related records
FdaApprovalPulse: PMA original approval (new class III device) FdaApprovalPulse: records in Maryland
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.