ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in May 2023. Updated May 31.
A roundup of FDA’s actions in May 2023
| NOVEL DEVICE APPROVALS |
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| Company |
Device |
Date |
Approval Type |
Approval Number |
||
| Foundation Medicine |
foundationone liquid cdx (f1 liquid cdx) | 5/3/23 |
Panel-track supplement | P 190032 S005 |
||
| Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Anti-SA | 5/5/23 | De Novo | DEN210038 & DEN210040 | ||
| Q-Med | restylane eyelight | 5/8/23 | Panel-track supplement | P040024 S135 | ||
| Swing Therapeutics | Stanza | 5/9/23 | De Novo | DEN220083 | ||
| Abbott Medical | prodigy, proclaim xr, proclaim plus, and externa... | 5/10/23 | Panel-track supplement | P010032 S191 | ||
| Allergan | skinvive by juvéderm | 5/11/23 | Panel-track supplement | P110033 S059 | ||
| Globus Medical | REFLECTScoliosis Correction System | 5/15/23 | HDE | H 210002 | ||
| MicroPort CRM USA | vega steroid-eluting endocardial leads |
5/17/23 | Original PMA | P 130010 | ||
| Abbott Medical | tactiflex ablation catheter, sensor enabled | 5/18/23 | Original PMA | P 220013 | ||
| BRAHMS GmbH | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | 5/18/23 | De Novo | DEN 220027 | ||
| Baxter Healthcare | perclot polysaccharide hemostatic system | 5/19/23 | Original PMA | P 210036 | ||
| Artivion | perclot polysaccharide hemostatic system | 5/19/23 | Original PMA | P 210036 | ||
| BREAKTHROUGH DEVICES |
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| Sponsor |
Device | Clinical Target |
Date |
|||
| DirectSync Surgical | Interbody device | Spinal fusion | 5/2/23 | |||
| JOGO Health | JOGO-CLBP digital therapy | Lower back pain | 5/2/23 | |||
| Cresco Spine | Spring Distraction System | Early onset scloiosis | 5/2/23 | |||
| Cognixion | Cognixion ONE Axon brain-computer interface | Neurodegenerative disease | 5/4/23 | |||
| Singlera Genomics | PDACatch Assay | Detection of pancreatic adenocarcinoma | 5/9/23 | |||
| Paradromics | Connexus DDI brain-comupter interface | Neurodegenerative disease | 5/18/23 | |||
| Locate Bio | LDGraft | Anterior lumbar interbody spinal fusion | 5/18/23 | |||
| Orlucent | Skin Fluorescence Imaging System | Handheld mole imaging | 5/22/23 | |||
| Pulse Medical | μFR system | FFR assessment in PCIs | 5/26/23 | |||
| QuantalX | Delphi-MD | Point-of-care neurodiagnostics | 5/30/23 | |||
| CardioRenal | Tenor system | At-home potassium measurement | 5/31/23 | |||
| WARNING LETTERS |
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| Company |
Citations |
Posting Date |
Issuing Office |
|||
| QSR |
5/16/23 | OHT 1: Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices |
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| CLASS 1 RECALLS |
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| Company |
Device |
Date |
Recall Number |
|||
| Cook | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, var. |
5/10/23 |
|
|||
| Cordis US | ANGIOGUARD RX / XP Emboli Capture Guidewire System, var. | 5/11/23 | Z-1483-2023 through Z-1495-2023 | |||
| ICU Medical | Replacement batteries, var. | 5/16/23 | Z-1465-2023 through Z-1568-2023 | |||
| Draeger Medical | Ventilator components, var. | 5/17/23 | Z-1439-2023 through Z-1459-2023 | |||
| Abiomed | Impella 5.5 with SmartAssist catheter |
5/18/23 | Z-1590-2023 | |||
| SD Biosensor | Pilot COVID-19 At-Home Test, Reference Number 9901 | 5/23/23 | Z-1594-2023 | |||
| Berlin Heart | EXCOR Pediatric Ventricular Assist Device Blood Pumps | 5/25/23 | Z-1618-2023 | |||
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
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| Test Kit Manufacturer & Commercial Labs |
Date |
|||||
| Access Medical Laboratories, Global Direct RT-PCR Test |
5/3/23 | |||||
| Nano-Ditech, Nano-Check COVID-19 Antigen At-Home Test | 5/12/23 | |||||
| BioTeke USA, Bio-Self COVID-19 Antigen Home Test | 5/22/23 | |||||
| Quest Diagnostics Nichols Institute, Quest Diagnostics Mpox Virus Qualitative Real-Time PCR | 5/22/23 | |||||
