ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in September 2023. Updated September 26, 2023.
A roundup of FDA’s actions in September 2023.
| NOVEL DEVICE APPROVALS |
||||
| Company |
Device |
Date |
Approval Type |
Approval Number |
| Xenex Disinfection Services |
LightStrike+ (MXSUV1-SL and MXSUV1-FT) | 9/1/23 |
De Novo | DEN230007 |
| S4 Medical | Esolution | 9/6/23 | De Novo | DEN230006 |
| LimFlow | LimFlow System | 9/11/23 | Original PMA | P220025 |
| Advanced Cooling Therapy, dba Attune Medical | ensoETM | 9/13/23 | De Novo | DEN230021 |
| Hemanext | Hemanext ONE | 9/16/23 | De Novo | BR220665 |
| BREAKTHROUGH DEVICES |
||||
| Sponsor |
Device | Clinical Target |
Date |
|
| Admetsys | PrecisionOne automated glucose control system. | Diabetes | 9/6/23 | |
| Ceribell | Point-of-care EEG | Delirium | 9/8/23 | |
| Annalise.AI | Radiology triage software | Obstructive hydrocephalus | 9/13/23 | |
| Inbrain Neuroelectronics | Intelligent Network Modulation System | Parkinson’s Disease | 9/19/23 | |
| Carlsmed | aprevo patient-specific fusion device | Cervical spine disease | 9/20/23 | |
| WARNING LETTERS |
||||
| Company |
Citations |
Posting Date |
Issuing Office |
|
| None as of 9/26/23 |
|
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| CLASS 1 RECALLS |
||||
| Company |
Device |
Date |
Recall Number |
|
| Mallinckrodt |
Mallinckrodt One-Way Valve, 22F x 22M | 9/9/23 | Z-2450-2023 | |
| Abbott Medical | Infinity 5 Implantable Pulse Generator |
9/11/23 | Z-2510-2023 |
|
| Abbott Medical | Infinity 7 Implantable Pulse Generator |
9/11/23 | Z-2511-2023 | |
| Abbott Medical | Proclaim Implantable Pulse Generators, var. | 9/11/23 | Z-2506-2023 through Z-2509-2023 | |
| Medline Industries | HUDSON RCI Addipak, UNIT DOSE VIALS |
9/14/23 | Z-2514-2023 | |
| Hamilton Medical | Intensive care ventilator, var. | 9/20/23 | Z-2525-2023 through Z-2530-2023 | |
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
||||
| Test Kit Manufacturer & Commercial Labs |
Date |
|||
| Princeton BioMeditech, ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test |
9/8/23 | |||
| Cue Health, Cue Mpox (Monkeypox) Molecular Test | 9/19/23 | |||
| 3EO Health, 3EO Health COVID-19 Test | 9/20/23 | |||
