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Personal Genome Diagnostics, Inc.: PMA approval for PGDx elio tissue complete CDx
Personal Genome Diagnostics, Inc. (Blatimore, Maryland): PMA approval for PGDx elio tissue complete CDx. Dated 97 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-03, 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 | Personal Genome Diagnostics, Inc. |
| Product | PGDx elio tissue complete CDx |
| Generic / ingredient | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Approval | PMA original approval (new class III device) |
| Application | P250036 |
| Decided | 2026-07-30 |
| Panel / class | Medical Genetics |
| Sponsor location | Blatimore, 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: 2026-07-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Tue, 03 Nov 2026 05:14:00 GMT
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Peer benchmark and outreach value: Personal Genome Diagnostics, 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 Personal Genome Diagnostics, Inc. in Blatimore, Maryland?
The FDA approved PGDx elio tissue complete CDx (P250036) for Personal Genome Diagnostics, Inc. on 2026-07-30: PMA original approval (new class iii device).
How does Personal Genome Diagnostics, Inc. compare to other Maryland FdaApprovalPulse records?
It is 97 days old; check the official source for later updates before acting.
Personal Genome Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Personal Genome Diagnostics, Inc. | Blatimore, MD | 2026-07-30 |
| 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.