ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in November 2023. Updated November 28.
A roundup of FDA’s actions in November 2023.
| NOVEL DEVICE APPROVALS |
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| Company |
Device |
Date |
Approval Type |
Approval Number |
| Abbott Molecular | CALCIVIS Imaging System | 11/1/23 | Original PMA | P 230003 |
| STEMCELL Technologies Canada | EasySep Human Bone Marrow | 11/6/23 | De Novo | DEN220090 |
| ReCor Medical | Paradise Ultrasound Renal Denervation System | 11/7/23 | Original PMA | P 220023 |
| Owlet Baby Care | Dream Sock | 11/8/23 | De Novo | DEN220091 |
| LetsGetChecked | Simple 2 Test | 11/15/23 | De Novo | DEN200070 |
| Foundation Medicine | FoundationOne CDx |
11/16/23 | Panel-track supplement | P 170019 S048 |
| Medtronic | Symplicity Spyral Renal Denervation System | 11/17/23 | Original PMA | P 220026 |
| restor3d | restor3d Total Talus Replacement | 11/17/23 | Humanitarian device exemption | H 230003 |
| TECHNOLAS PERFECT VISION | TECHNOLAS TENEO 317 (MODEL 2) |
11/22/23 | Panel-track supplement | P990027 S021 |
| BREAKTHROUGH DEVICES |
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| Sponsor |
Device | Clinical Target |
Date |
|
| Toku | CLAiR retinal scan platform | Cardiovascular risk assessment | 11/02/23 | |
| Roche | Elecsys Neurofilament Light Chain test | Multiple Sclerosis | 11/9/23 | |
| Brixton Biosciences | Coolio Therapy | Pain management | 11/13/23 | |
| Mednition | KATE Sepsis | Early sepsis detection | 11/14/23 | |
| Supera Medical | Supira System pVAD | Hemodynamic support | 11/21/23 | |
| Inflammatix | TriVerity Acute Infection and Sepsis Test System | Sepsis | 11/28/23 | |
| Acrivon Therapeutics | OncoSignature Assay | Ovarian cancer | 11/28/23 | |
| AWAK Technologies | AI-enabled KDPP model | Kidney disease | ||
| WARNING LETTERS |
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| Company |
Citations |
Posting Date |
Issuing Office |
|
| Premarket, Misbranding, QSR |
11/7/23 | OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality |
||
| Wello Inc. | Misbranding | 11/14/23 | OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices |
|
| Ming Fai Industrial | QSR | 11/14/23 | OHT8: Office of Radiological Health Office of Product Evaluation and Quality |
|
| Wello | Misbranding | 11/14/23 | OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality |
|
| CLASS 1 RECALLS |
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| Company |
Device |
Date |
Recall Number |
|
| Covidien | Stolen McGRATH MAC Video Laryngoscopes |
11/02/23 | Z- 0144-2024 | |
| CareFusion 303 | Alaris pump control units, var. | 11/7/23 | Z-0184-2024 through Z-0186-2024 | |
| Baxter Healthcare | Novum IQ Syringe infusion system |
11/9/23 | Z-0151- 2024 | |
| Olympus Corp. of the Americas | Evis Bronchovideoscopies, var. | 11/9/23 | Z-0189-2024 through Z-0194-2024 | |
| Cordis US | Cordis ANGIOGRAPHIC CATHETERIZATION SETS | 11/9/23 | Z- 0286-2024 | |
| Medtronic Navigation | StealthStation S8 Application version 2.0 and 2.0.1 |
11/10/23 | Z- 0188-2024 | |
| Unomedical | Varisoft infusions sets, var. | 11/21/23 | Z- 0232-2024 through Z- 0234-2024 | |
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
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| Test Kit Manufacturer & Commercial Labs |
Date |
|||
| SEKISUI Diagnostics, OSOM COVID-19 Antigen Rapid Test | 11/15/23 | |||
| Roche Molecular Systems, cobas SARS-CoV-2 & Influenza A/B v2 |
11/16/23 | |||
