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Fraud blocks under magnifying glass

US DOJ announces two new field offices for COVID fraud enforcement

Aug. 25, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) has been aggressively pursuing fraud perpetrated on the American public in connection with the COVID-19 pandemic, but the formal end of the U.S. public health emergency might seem to suggest that these efforts would be winding down. Nonetheless, deputy attorney general Lisa Monaco has announced that DOJ will open two new strike force offices under the agency’s COVID fraud operations, making clear that the agency is still intent on chasing down fraudsters across the U.S.
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Medtronic's Inceptiv neurostimulator

Medtronic wins CE mark for closed-loop spinal cord stimulator

Aug. 25, 2023
By Meg Bryant
The European Commission has granted CE mark approval to Medtronic plc for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). The device is the first Medtronic SCS to sense an individual’s biological cues and make adjustments in real time to control pain all day long. Dublin-based Medtronic plans to launch Inceptiv in Europe in the coming months.
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Regulatory actions for Aug. 24, 2023

Aug. 24, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Dizal, Immix, Nexcella, Pfizer.
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Regulatory actions for Aug. 24, 2023

Aug. 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Paragonix.
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EU flags at European Commission building

The EC releases update on MDR-IVDR applications and certification

Aug. 24, 2023
By Bernard Banga
The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR).
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Imeka white matter tracking

FDA clearance, reimbursement codes greet Imeka’s white matter tracking tool

Aug. 24, 2023
By David Godkin
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.
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Medtronic - Symplicty Spyral HTN

Divergent trial results tank Medtronic’s Symplicity Spyral at FDA advisory

Aug. 24, 2023
By Mark McCarty
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
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Regulatory actions for Aug. 23, 2023

Aug. 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akava, Amgen, Fulcrum, Geron, Janssen, Nascent, Pfizer, Vigeneron, Vincerx.
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Regulatory actions for Aug. 23, 2023

Aug. 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fresenius, Geneseeq, Pixcell, Sparrow Bioacoustics, Telesair.
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US FTC taps Covington’s Liu for director of Bureau of Competition

Aug. 23, 2023
By Mark McCarty
The U.S. Federal Trade Commission has picked Henry Liu of the law firm of Covington & Burling to run the agency’s Bureau of Competition, a seat that was vacated earlier this year when Holly Vedova retired.
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