ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in September 2022. Updated September 30.
A roundup of FDA’s actions in September 2022.
| NOVEL DEVICE APPROVALS |
||||||
| Company |
Device |
Date |
Approval Type |
Approval Number |
||
| Vesalio |
|
9/9/22 |
HDE |
H210004 |
||
| Edwards Lifesciences | pascal precision transcatheter valve repair system | 9/14/22 | Original PMA | P220003 | ||
| Medtronic Vascular | resolute onyx zotarolimus-eluting coronary stent s... | 9/15/22 | Panel-track supplement | P160043 S058 | ||
| Phagenesis Limited | Phagenyx System | 9/16/22 | De Novo | DEN220025 | ||
| Life Technologies | oncomine dx target test | 9/21/22 | Panel-track supplement | P1600045 S031 | ||
| Siemens Healthcare Diagnostics | INNOVANCE VWF Ac | 9/29/22 | De Novo | DEN200067 | ||
| Ventana Medical Systems | pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody | 9/30/22 | Panel-track supplement | P990081 S047
|
||
| BREAKTHROUGH DEVICES |
||||||
| Sponsor |
Clinical Target |
Date |
||||
| AINOSTICS |
BR[AI]N AI-based imaging analysis | Early dementia detection |
9/5/22 |
|||
| Ceribell | POC EEG system | Delerium | 9/8/22 | |||
| CurveBeam | OssView diagnostic software | Bone fragility & fracture risk | 9/12/22 | |||
| Portrero Medical | AKI Predict predictive algorithm | Acute kidney injury | 9/13/22 | |||
| Advanced Nano Therapies | SirPlux Duo Drug-Coated Balloon | Coronary artery disease | 9/19/22 | |||
| XVIVO | Liver assist device | Liver transplantation | 9/20/22 | |||
| Predicine | PredicineCARETM cfDNA Assay | Liquid biopsy | 9/20/22 | |||
| Cyberliver | CirrhoCare device | out-of-hospital management of cirrhosis patients | 9/26/22 | |||
| WARNING LETTERS |
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| Company |
Citations |
Posting Date |
Issuing Office |
|||
| QST |
9/27/22 |
OHT 4: Office of Surgery & Infection Control Devices |
||||
| CLASS 1 RECALLS |
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| Company |
Device |
Date |
Recall Number |
|||
| Medtronic Xomed | NIM EMG Endotracheal Tube, var. |
9/1/22 | Z-1520-2022 & Z-1521-2022 | |||
| Medtronic Xomed | NIM CONTACT EMG Endotracheal Tube | 9/1/22 | Z-1519-2022 | |||
| Philips Respironics | Philips BiPAP V30 Auto, Rx Only |
9/9/22 | Z-1656-2022 | |||
| Philips Respironics | Philips BiPAP A40, Rx Only |
9/9/22 | Z-1655-2022 | |||
| Philips Respironics | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only |
9/9/22 | Z-1659-2022 | |||
| Philips Respironics | Philips OmniLab Advanced+, Rx Only |
9/9/22 | Z-1657-2022 | |||
| Philips Respironics | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only |
9/9/22 | Z-1658-2022 | |||
| Philips Respironics | Philips BiPAP A30, Rx Only | 9/9/22 | Z-1654-2022 | |||
| Baxter Healthcare | Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike | 9/14/22 | Z-1653-2022 | |||
| Cardiac Assist | TANDEM LIFE LivaNova LIFESPARC Controller |
9/23/22 | Z-1763-2022 | |||
| Philips Respironics | Philips Respironics DreamWear Full Face Mask | 9/30/22 | Z-1781-2022 | |||
| Philips Respironics | Wisp and Wisp Youth Nasal Mask | 9/30/22 | Z-1783-2022 | |||
| Philips Respironics | Therapy Mask 3100 NC/SP | 9/30/22 | Z-1784-2022 | |||
| Philips Respironics | DreamWisp Nasal Mask with Over the Nose Cushion | 9/30/22 | Z-1782-2022 | |||
| Philips Respironics | Philips Respironics Amara View Minimal Contact Full-Face Mask | 9/30/22 | Z-1780-2022 | |||
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
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| Test Kit Manufacturer & Commercial Labs |
Date |
|||||
| Quest Diagnostics Nichols Institute, Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR | 9/15/22 | |||||
