ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2022. Updated April 30.
A roundup of FDA’s actions in April 2022.
NOVEL DEVICE APPROVALS |
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Company |
Device |
Date |
Approval Type |
Approval Number |
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Biosensors international |
4/14/22 |
Original PMA |
P190020 |
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Vascutek |
4/19/21 |
Original PMA |
P210006 |
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TransMedics | ocs heart system | 4/27/22 | Panel-track supplement |
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Silk Road Medical | enroute transcarotid stent system | 4/28/22 | Panel-track supplement |
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BioFire Joint Infection (JI) Panel | 4/29/22 | De Novo | DEN200066 | ||||||
BREAKTHROUGH DEVICES |
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Sponsor |
Device |
Clinical Target |
Date |
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Bridge to Life |
LifeCradle Heart Preservation Transport System |
Heart preservation and transportation |
4/21/22 |
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Quanterix |
Simoa neurofilament light chain (NfL) plasma test |
Relapsing-remitting MS |
4/22/22 |
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Nocira | Nocira AVPI system | Migraine | 4/27/22 | |||||||
WARNING LETTERS |
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Company |
Citations |
Posting Date |
Issuing Office |
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Premarket |
4/5/22 |
OHT4: Office of Surgical and Infection Control Devices |
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CLASS 1 RECALLS |
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Company |
Device |
Date |
Recall Number |
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Sensory Medical |
4/14/22 |
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Medtronic |
4/18/22 |
Z-0927-2022 |
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Respironics California |
4/18/22 |
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Respironics California |
4/18/22 |
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Respironics California |
4/18/22 |
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Covidien |
4/25/22 |
Z-0966-2022 |
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Celltrion | Celltrion DiaTrust COVID-19 Ag Rapid Test |
4/27/22 |
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NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
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Test Kit Manufacturer & Commercial Labs |
Date Issued |
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4/6/22 |
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DC Department of Health,Test Yourself DC At-Home COVID-19 Collection Kit |
4/6/22 |
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Xiamen Boson Biotech,Rapid SARS-CoV-2 Antigen Test Card |
4/7/22 |
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UCSD BCG EXCITE Lab, UCSD EXCITE COVID-19 EL Test |
4/7/22 |
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Cleveland Clinic Tomsich Institute,SelfCheck cobas SARS-CoV-2 + Flu Assay |
4/11/22 |
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MicroGEM US,MicroGEM Sal6830 SARS-CoV-2 Saliva Test |
4/14/22 |
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OPTI Medical Systems,OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2) |
4/21/22 |
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Audere, HealthPulse@home Fusion | 4/26/22 |