Cleveland Diagnostics, Inc.: PMA supplement approved for IsoPSA® Assay
Cleveland Diagnostics, Inc. (Cleveland, Ohio): PMA supplement approved for IsoPSA® Assay. Dated 99 days ago, it serves as a historical benchmark. Score 30/100. 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: 2 related OH FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Cleveland Diagnostics, Inc. |
| Product | IsoPSA® Assay |
| Generic / ingredient | Multi-analyte test system with algorithmic analysis for detection of prostate cancer |
| Approval | PMA supplement (device change) |
| Application | P200048 S001 |
| Decided | 2026-07-28 |
| Panel / class | Immunology |
| Sponsor location | Cleveland, OH |
| Peer records CSV (3 OH 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: 2026-07-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (OH first): AtriCure, Inc. · AtriCure, Inc. · Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Browse all by state and category →
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: Cleveland Diagnostics, Inc. and 3 Ohio peers
- Ohio FdaApprovalPulse records like this one: 3
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Cleveland Diagnostics, Inc. in Cleveland, Ohio?
The FDA approved IsoPSA® Assay (P200048 S001) for Cleveland Diagnostics, Inc. on 2026-07-28: PMA supplement (device change).
How does Cleveland Diagnostics, Inc. compare to other Ohio FdaApprovalPulse records?
It is 99 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Cleveland Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Cleveland Diagnostics, Inc. | Cleveland, OH | 2026-07-28 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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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.