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 |
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Company |
Citations |
Posting Date |
Issuing Office |
|
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 |
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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 |
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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 |