FDA Output July 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 July 2023. Updated July 31, 2023.

A roundup of FDA’s actions in July 2023

NOVEL DEVICE APPROVALS

Company

Device

Date

Approval Type

Approval Number

Pramand

CraniSeal Dural Sealant  

7/6/23

Original PMA P 220014
Better Therapeutics BT-001 7/7/23 De Novo DEN220058
Ruthless dba Ruthless Spine Ruthless Spine RJB 7/14/23 De Novo DEN230012
Galen Robotics Galen ES Cooperative Surgical Assistant 7/19/23 De Novo DEN220047
Cordis USA PALMAZ MULLINS XD Pulmonary Stent 7/21/23 Original PMA P220004
MicroCube Minitouch 3.8 Era System
7/28/23 Original PMA P230002

BREAKTHROUGH DEVICES

Sponsor

Device

Clinical Target

Date

T2 Biosystems Candida auris molecular diagnostic Candida aurus 7/20/23
Marpe Technologies Full-body dermatology screening system Dermatology 7/31/23

WARNING LETTERS

Company

Citations

Posting Date

Issuing Office

ZYTO Technologies

QSR

7/11/23 OHT 5: Neurological and Physical Medical Devices
Outset Medical Premarket 7/18/23 OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Edge Biologicals QSR 7/18/23 Office of Medical Device and Radiological
Health Division 2 – Central

CLASS 1 RECALLS

Company

Device

Date

Recall Number

GE Healthcare Finland TruSignal Sensors, var.
7/7/23 Z-2026-2023 through Z-2034-2023
Quidel Cardiovasular Quidel Triage Cardiac Panel
7/7/23 Z-1974-2023
Draeger Medica Oxylog 3000 Plus emergency and transport ventilator 7/8/23 Z-2018-2023
Abbott Abbott Amplatzer Steerable Delivery Sheath 7/11/23 Z-2110-2023
Baxter Healthcare Spectrum IQ Infusion System with Dose IQ Safety Software 7/13/23 Z-2104-2023
Baxter Healthcare SIGMA Spectrum Infusion Pump 7/13/23 Z-2103-2023
Abiomed Impella  micro axial blood pumps, var. 7/14/23 Z-2111-2023 through Z-2116-2023
Olympus Corp. of the Americas Olympus bronchovideoscopies, var. 7/17/23 Z-2011-2023 through Z-2017-2023
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pumps, var.
7/19/23 Z-2149-2023 & Z-2150-2023
Hamilton Medical Hamilton ventilators, var. 7/21/23 Z-2139-2023 through Z-2142-2023

NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS

Test Kit Manufacturer & Commercial Labs

Date

Immunostics, Swab-N-Go Home Test COVID-19 Ag
7/17/23
Abbott Molecular, Alinity m MPXV 7/18/23
Alphadera Labs, ALPHADx SARS-COV-2 RT-PCR Test 7/20/23
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