ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in January 2023. Updated January 31.
A roundup of FDA’s actions in January 2023
NOVEL DEVICE APPROVALS |
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Company |
Device |
Date |
Approval Type |
Approval Number |
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Cirtec Medical | virtis sacral neuromodulation system | 1/11/23 | Original PMA | P170001 | ||
Abbott Medical | prodigy, proclaim, and proclaim xr spinal cord stimulation systems | 1/24/23 | Panel-track supplement | P010032 S189 |
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Guardant Health | guardant360 cdx | 1/27/23 | Panel-track supplement | P200010 S010 |
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BREAKTHROUGH DEVICES |
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Sponsor |
Device | Clinical Target |
Date |
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Datar Cancer Genetics | TriNetra-Glio liquid biopsy | Brain tumors | 1/02/23 | |||
Burning Rock | OverC liquid biopsy | Multiple cancers | 1/03/23 | |||
Prapela | Vibrating mattress pad | Apnea of Prematurity | 1/05/23 | |||
Opticyte | Cell O₂ Patient Monitor | Organ failure detection | 1/9/23 | |||
EndoTheia | Enhanced endoscopy tools | ENT | 1/10/23
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Micronoma | OncobiotaLUNG liquid biopsy | Lung cancer | 1/10/23 | |||
Medcura | LifeGel Absorbable Surgical Hemostat | Surgical bleeding management | 1/12/23 | |||
Sensydia | Cardiac Performance System NI monitoring | Heart failure | 1/19/23 | |||
CardioRenal Systems | RenalGuart Therapy | Acute kidney injury | 1/20/23 | |||
WARNING LETTERS |
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Company |
Citations |
Posting Date |
Issuing Office |
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QSR |
1/10/23 | OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices |
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Olympus Medical Systems | Postmarket (MDR) | 1/10/23 | OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices |
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RightEye | QSR | 1/31/23 | OHT 5: Office of Neurological & Physical Medicine Devices | |||
CLASS 1 RECALLS |
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Company |
Device |
Date |
Recall Number |
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Philips Respironics |
Philips Garbin Ventilator, Model Number 1058180B | 1/6/23 | Z-0884-2023 | |||
Philips Respironics | Philips Trilogy Ventilators, 100 and 200, var. models |
1/6/23 |
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Emergent Protective Products | RSDL (Reactive Skin Decontamination Lotion) Kit |
1/10/23 | Z-0773-2023 | |||
Covidien | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter |
1/12/23 | Z-0877-2023 | |||
Datascope | Cardiosave Hybrid Intra-Aortic Balloon Pumps |
1/19/23 | Z-0885-2023 & Z-0886-2023 | |||
Cardiac Assist | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES |
1/19/23 | Z-0926-2023 | |||
Getinge US Sales | Getinge Flow Anesthesia System Parts, var. | 1/26/23 | Z-0959-2023 through Z-0961-2023 | |||
Smiths Medical ASD | CADD Disposables, var. |
1/30/23 | Z-0963-2023 through Z-0966-2023 | |||
NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
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Test Kit Manufacturer & Commercial Labs |
Date |
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DiaCarta, QuantiVirus MPXV Test Kit |
1/10/23 |