ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in September 2023. Updated September 30, 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 | P2200025 | ||
| Advanced Cooling Therapy, dba Attune Medical | ensoETM | 9/13/23 | De Novo | DEN230021 | ||
| Hemanext | Hemanext ONE | 9/16/23 | De Novo | BR220665 | ||
| Terumo Medical | Cross-Seal Suture-Mediated Vascular Closure Device | 9/26/23 | Original PMA | P210017 | ||
| Laminate Medical Technologies | VasQ | 9/26/23 | De Novo | DEN220023 | ||
| Merz North America | Belotero Balance (+) Lidocaine | 9/27/23 | Panel-track supplement | P 090016 S050 | ||
| EntroGen | CRCDx RAS Mutation Detection Assay Kit | 9/29/23 | Original PMA | P22005 | ||
|
Procise ADL | 9/29/23 | De Novo | DEN220023 | ||
|
Procise IFX | 9/29/23 | De Novo | DEN210056 | ||
| Invitae | Invitae Common Hereditary Cancers Panel | 9/29/23 | De Novo | DEN210011 | ||
| 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 | |||
| Gravitas Medical | Entarik Gravitas Feeding Tube System | nasoenteric feeding for neonatal patients | 9/26/23 | |||
| SeaStar Medical Holdings | Selective Cytopheretic Device | Cardiorenal syndrome | 9/29/23 | |||
| WARNING LETTERS |
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| Company |
Citations |
Posting Date |
Issuing Office |
|||
| None as of 9/26/23 |
|
|||||
| 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 | |||
| Philips Respironics | Philips Respironics V60/V60 Plus Ventilator |
9/28/23 | Z-2631-2023 | |||
| 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 | 9/19/23 | |||||
| Tangen Biosciences, TangenDx SARS-CoV-2 Molecular Test | 9/29/23 | |||||
| SD Biosensor, STANDARD Q COVID-19 Ag Test 2.0 | 9/29/23 | |||||
