ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in October 2022. Updated October 31.
A roundup of FDA’s actions in October 2022.
| NOVEL DEVICE APPROVALS |
||||||
| Company |
Device |
Date |
Approval Type |
Approval Number |
||
| SRS Medical |
|
10/7/22 |
Panel-track supplement |
P060010 S013 |
||
| BrainCool | The Cooral System | 10/14/22 | De Novo | DEN210027 | ||
| Intelligent Ultrasound Limited | ScanNav Anatomy Peripheral Nerve Block | 10/18/22 | De Novo | DEN220024 | ||
| Avive Solutions | avive automated external defibrillator system | 10/31/22 | Original PMA | P210015 | ||
| BREAKTHROUGH DEVICES |
||||||
| Sponsor |
Device | Clinical Target |
Date |
|||
| Axoft | Brain-machine interface | Neurological disorders | 10/18/22 | |||
| Sinaptica Therapeutics | SinaptiStim electromagenetic system | AD-related cognitive & functional decline | 10/19/22 | |||
| CorVista Health | CorVista POC Dx system | Pulmonary hypertension | 10/25/22 | |||
| EndoStim | EndoStim neurostimulation system | GERD | 10/25/22 | |||
| WARNING LETTERS |
||||||
| Company |
Citations |
Posting Date |
Issuing Office |
|||
| Premarket |
10/4/22 |
OHT 4: Office of Surgery & Infection Control Devices |
||||
| Thai Union Group | QSR | 10/18/22 | Office of Medical Device and Radiological Health Division 3 |
|||
| Forcemech International | QSR | 10/18/22 | Office of Medical Device and Radiological Health Division 3 |
|||
| CLASS 1 RECALLS |
||||||
| Company |
Device |
Date |
Recall Number |
|||
| Fresenius Kabi USA | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | 10/6/22 | Z-0002-2023 | |||
| Jiangsu Well Biotech | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device |
10/8/22 | Z-0001-2023 | |||
| Teleflex | Iso-Gard Filter S var. | 10/14/22 | Z-0072-2023 through Z-0076-2023 | |||
| Teleflex | Filter + Catheter Mount |
10/14/22 | Z-0077-2023 | |||
| Baxter Healthcare | Hillrom Centrella Hospital Bed with WatchCare |
10/31/22 | Z-0141-2023 | |||
| Baxter Healthcare | Hillrom Hospital Bed Accessory, var. | 10/31/22 | Z-0142-2023 – Z-0145-2023 | |||
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
||||||
| Test Kit Manufacturer & Commercial Labs |
Date |
|||||
| Abbott Molecular, Alinity m MPXV |
10/7/22 | |||||
| Aptitude Medical Systems, Metrix COVID-19 Test | 10/18/22 | |||||
