FDA Output January 2023

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ARTICLE SUMMARY:

Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in January 2023. Updated January 24.

A roundup of FDA’s actions in January 2023

NOVEL DEVICE APPROVALS

Company

Device

Date

Approval Type

Approval Number

Cirtec Medical virtis sacral neuromodulation system 1/11/23 Original PMA P170001

BREAKTHROUGH DEVICES

Sponsor

Device

Clinical Target

Date

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

 

Micronoma OncobiotaLUNG liquid biopsy Lung cancer 1/10/23
Medcura LifeGel Absorbable Surgical Hemostat Surgical bleeding management 1/12/23
CardioRenal Systems RenalGuart Therapy Acute kidney injury 1/20/23

WARNING LETTERS

Company

Citations

Posting Date

Issuing Office

Aizu Olympus

QSR

1/10/23 OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Olympus Medical Systems Postmarket (MDR) 1/10/23 OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices

CLASS 1 RECALLS

Company

Device

Date

Recall Number

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
 

Z-0882-2023 and Z-0883-2023

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

NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS

Test Kit Manufacturer & Commercial Labs

Date

DiaCarta, QuantiVirus MPXV Test Kit
1/10/23
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