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BioWorld - Saturday, February 21, 2026
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Medical technology
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Regulatory actions for December 23, 2024

Dec. 23, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardia Medical, Sequana Medical.
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Merit Wrapsody

Merit unwraps Wrapsody endoprosthesis PMA for the holidays

Dec. 20, 2024
By Holland Johnson
Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
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OP5_INSU_POD_PDM_NoADH_RIGHT_RGB.jpg

New partnerships, approvals pump prospects for insulin delivery devices

Dec. 20, 2024
By Annette Boyle
A spate of year-end collaborations highlights growing enthusiasm for expanding use of automated insulin delivery devices or pumps in management of type 1 diabetes only to include many patients with type 2 diabetes. Beneficiaries include pump makers Tandem Diabetes Care Inc., Insulet Corp. and Medtronic plc as well as the leaders in the continuous glucose monitoring market, Abbott Laboratories and Dexcom Inc.
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Financings for December 20, 2024

Dec. 20, 2024
Med-tech firms raising money in public or private financings, including: Balt.
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In the clinic for December 20, 2024

Dec. 20, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Quantum-Si.
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Other news to note for December 20, 2024

Dec. 20, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Commure, Memora Health, Modular Medical, Orasure Technologies, Orthalign, Sherlock Biosciences.
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Regulatory actions for December 20, 2024

Dec. 20, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita, Humacyte, Merit Medical, Onward, Roivios, Salignostics, Zurimed.
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DermR collection device

Skin cancer study: Dermr patch as effective as skin biopsy

Dec. 20, 2024
By Tamra Sami
A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.
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Hand holding FDA blocks

Uncertainty builds at US FDA with retirements, CR questions

Dec. 19, 2024
By Mari Serebrov
The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have come and gone.
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Oura Ring

Ōura closes $200M series D, Dexcom invests $75M

Dec. 19, 2024
By Annette Boyle
Dexcom Inc. put real money behind expanding its integration efforts, with a $75 million investment in the $200 million series D for Ōura Health Oy, the maker of the Ōura smart ring. Ōura and Dexcom also provided details on a strategic partnership that integrates data from Dexcom’s continuous glucose monitors with vital sign, sleep, stress, heart health and activity data from the Ōura ring.
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