FDA Output September 2022

article image
ARTICLE SUMMARY:

Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in September 2022. Updated September 27.

A roundup of FDA’s actions in September 2022.

NOVEL DEVICE APPROVALS

Company

Device

Date

Approval Type

Approval Number

Vesalio

  NeVa Vs Temporary percutaneous transluminal cerebral artery dilatation device

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

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

Company

Citations

Posting Date

Issuing Office

Med Pen Concepts

QST

9/27/22

OHT 4: Office of Surgery & Infection Control Devices

CLASS 1 RECALLS

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

NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS

Test Kit Manufacturer & Commercial Labs

Date

Quest Diagnostics Nichols Institute, Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR 9/15/22
×

This article is restricted to subscribers only.

Sign in to continue reading.

Questions?

We're here to help! Please contact us at: