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BioWorld - Friday, May 22, 2026
Home » Topics » Medical technology

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Regulatory front

FDA issues advisory regarding false positive antigen tests

Nov. 3, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of discontinued Medtronic catheter.
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BioWorld MedTech’s Oncology Extra for Nov. 3, 2020

Nov. 3, 2020
By Mark McCarty and Anette Breindl
Keeping you up to date on recent developments in oncology, including: Microfluidic provides model for testing therapies on pancreatic ductal adenocarcinoma; Cutting off AML’s metabolic escape route; NGF: PDAC’s VEGF?; Revving up cisplatin by targeting Rev7.
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Regulatory actions for Nov. 3, 2020

Nov. 3, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics.
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Other news to note for Nov. 3, 2020

Nov. 3, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo Technologies, Biocartis Group, Coloplast, Decision Diagnostics, DJO Global, Endpoint Health, Geneprodx, Hutchinson Technology, Joline, Mir Scientific, Morton Comprehensive Health Services, Motus GI, Nine Continents Medical, Novarad, Ossdsign, Oxford Gene Technology, Remark Holdings, Resonetics, Sirakoss, Stryker, Wright Medical Group.
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In the clinic for Nov. 3, 2020

Nov. 3, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Immunovia, Seaspine, Strata Skin Sciences.
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Financings for Nov. 3, 2020

Nov. 3, 2020
Med-tech firms raising money in public or private financings, including: Fountain Healthcare Partners, Kyowa Kirin, Massive Bio, Nurami Medical.
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Appointments and advancements for Nov. 3, 2020

Nov. 3, 2020
New hires and promotions in the med-tech industry, including: Aethlon, American Injectables, Fast Biomedical, Inspire MD.
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U.S. Capitol building

U.S. health policies will reflect congressional changes

Nov. 3, 2020
By Mari Serebrov
To say a lot is riding on the Nov. 3 presidential and congressional election in the U.S. would be an understatement, as the outcome could impact drug pricing, patent reform, research spending and pandemic response and preparedness.
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Skin exam

Castle Biosciences launches differential test for challenging skin lesions

Nov. 2, 2020
By Annette Boyle
Castle Biosciences Inc.'s Decisiondx Diffdx-Melanoma test is now commercially available to help dermatopathologists better characterize melanocytic lesions. About 15% of suspicious pigmented skin lesions cannot be definitively determined to be benign or malignant using common methods. The new gene expression profile test reduces the number of indeterminate results by more than 70%.
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Intersect ENT Propel sinus implants

Intersect reports $22.7M in third quarter revenue

Nov. 2, 2020
By Mary Ellen Schneider
Intersect ENT Inc., a sinusitis implant company, reported $22.7 million in third quarter revenue, driven largely by a rebound in procedures with its Propel implants for chronic rhinosinusitis. This figure marks a 6% decline from the $24.1 million reported in the third quarter of 2019.
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