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BioWorld - Saturday, May 16, 2026
Home » Topics » Medical technology

Medical technology
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Apple Computer Inc. logo

Apple, FDA deliver good news for Masimo

Dec. 19, 2023
By Annette Boyle
The holidays are looking brighter for Masimo Corp. with two bits of good cheer this week for the company. Apple Inc. confirmed to BioWorld that it will preemptively pull two smartwatches from its website and retailers in response to a Masimo infringement case that persuaded the International Trade Commission to block their import.
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Gavel with whistle

$14.7M pay-up time for Biotelemetry and Lifewatch

Dec. 19, 2023
By Annette Boyle
Biotelemetry Inc. and its subsidiary, Lifewatch Services Inc., agreed to pay $14.7 million to settle a whistleblower case alleging overbilling for remote cardiac monitoring. The qui tam case contended that the company’s online portal for its ACT-3L/MCT-3L device and its staff consistently and intentionally forced physicians’ staff to select or themselves selected the most expensive application for the device, despite intent and even written instructions to choose a less expensive service.
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Uromems urinary sphincter

Uromems develops altitude responsive element for its artificial urinary sphincter device

Dec. 19, 2023
By Simon Kerton
Uromems SAS is seeking patent protection for a system for the control of an inflatable implant device with a variable volume fluid reservoir that may be used to plug an anatomical duct such as a urethra, gastric duct, colon, or rectum, or configured for use as a penile implant.
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Appointments and advancements for Dec. 19, 2023

Dec. 19, 2023
New hires and promotions in the med-tech industry, including: Avacta, Biostem Technologies, Impact Biotech, Trinity Biotech.
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Financings for Dec. 19, 2023

Dec. 19, 2023
Med-tech firms raising money in public or private financings, including: BBS-Bioactive Bone Substitutes.
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In the clinic for Dec. 19, 2023

Dec. 19, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ablative Solutions, Sight Sciences.
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Other news to note for Dec. 19, 2023

Dec. 19, 2023
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avantik, Bristo-Myers, Butterfly Network, CPBS, Elekta, Enable Biosciences, Etao International, Hermann Bantleon, Koning Corp., LTS Lohmann, Mainz Biomed, Marston Technical Services, Mendaera.
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Top Trends Firsts, finish line flag

First CRISPR-based therapeutic is scientific, regulatory milestone

Dec. 18, 2023
By Anette Breindl
Both the U.K. MHRA and the U.S. FDA approved their first CRISPR-based gene therapy in 2023. Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) was approved by the MHRA in November and the FDA on Dec. 8. The U.K. approval is for both severe sickle cell disease (SCD) and transfusion-dependent thalassemia (TDT). In the U.S., the approval is for severe SCD, with a PDUFA date for TDT coming up in spring 2024.
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Med-tech gainers and losers for Dec. 11-15, 2023

Dec. 18, 2023
The top 10 med-tech stock gainers and losers for the week.
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Regulatory actions for Dec. 18, 2023

Dec. 18, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioamerica, Masimo, Neuronetics, Tyber Medical, Fuse-AI.
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