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BioWorld - Wednesday, May 27, 2026
Home » Topics » Medical technology

Medical technology
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Jeff Shuren
Virtual Medtech Conference

FDA’s Shuren pounds on inadequacy of statute in CDRH town hall

Oct. 6, 2020
By Mark McCarty
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
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Costa Rican flag

Costa Rica clears the way for untested ventilators developed by its universities

Oct. 6, 2020
By Sergio Held
CAJICA, Colombia –The government of Costa Rica issued guidelines recently that will allow the country’s social security system to source the country's hospitals with ventilators produced by the faculties of the universities of the Latin American country, during the COVID-19 outbreak.
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Product image

Astrazeneca strikes deal with Impedimed for Sozo platform in heart failure, kidney disease trial

Oct. 6, 2020
By Tamra Sami
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
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Regulatory front

Stakeholders sound off on Medicare doc fee, outpatient drafts

Oct. 6, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for Oct. 6, 2020

Oct. 6, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosense Webster, Setpoint Medical.
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Other news to note for Oct. 6, 2020

Oct. 6, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, 1Health.io, Abbott Laboratories, Biologica Technologies, Clear, Diagnostic Robotics, Emanate Wireless, Genentech, Imbio, Ion Beam Applications, Iprocedures, Medshape, Mesuron, Mgroup, Neupath Health, Opum US, Pharmajet, Pivot Design Group, Qiagen, Quanterix, Quest Diagnostics, Readcoor, Sanara Medtech, Shin-Ho Instruments, Tyber Medical, Vizient, Xtant Medical.
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In the clinic for Oct. 6, 2020

Oct. 6, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Beckman Coulter, Daxor, Guardant Health.
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Financings for Oct. 6, 2020

Oct. 6, 2020
Med-tech firms raising money in public or private financings, including: Butterfly Medical, Cardiawave.
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Appointments and advancements for Oct. 6, 2020

Oct. 6, 2020
New hires and promotions in the med-tech industry, including: Cmr Surgical, Inspiremd, Karius.
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BioWorld MedTech’s Oncology Extra for Oct. 6, 2020

Oct. 6, 2020
By Mark McCarty and Anette Breindl
Keeping you up to date on recent developments in oncology, including: New data cast doubt on post-resection radiotherapy for NSCLC; Carcinogens need not be mutagens; Myelin regulatory factor assists pancreatic cancer cells; Deepmedic provides glioblastoma segmentation with sparsified data.
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