Siemens Healthcare Diagnostics, Inc.: PMA approval for Atellica IM free PSA II (fPSAII)
Siemens Healthcare Diagnostics, Inc. (Tarrytown, New York): PMA approval for Atellica IM free PSA II (fPSAII). Dated 177 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: 3 related NY FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Siemens Healthcare Diagnostics, Inc. |
| Product | Atellica IM free PSA II (fPSAII) |
| Generic / ingredient | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Approval | PMA original approval (new class III device) |
| Application | P250026 |
| Decided | 2026-05-11 |
| Panel / class | Immunology |
| Sponsor location | Tarrytown, NY |
| Peer records CSV (4 NY 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: 2026-05-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (NY first): Siemens Healthcare Diagnostics, Inc. · Bausch & Lomb, Inc. · NuMED, Inc. · Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · 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: Siemens Healthcare Diagnostics, Inc. and 4 New York peers
- New York FdaApprovalPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $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 Siemens Healthcare Diagnostics, Inc. in Tarrytown, New York?
The FDA approved Atellica IM free PSA II (fPSAII) (P250026) for Siemens Healthcare Diagnostics, Inc. on 2026-05-11: PMA original approval (new class iii device).
How does Siemens Healthcare Diagnostics, Inc. compare to other New York FdaApprovalPulse records?
It is 177 days old; check the official source for later updates before acting.
Siemens Healthcare Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | Tarrytown, NY | 2026-05-11 |
| Vivasure Medical , Ltd. | Galway | 2026-10-16 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| Rejoni, Inc. | Bedford, MA | 2026-09-28 |
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FdaApprovalPulse: PMA original approval (new class III device) FdaApprovalPulse: records in New York
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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.