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BioWorld - Sunday, April 12, 2026
Home » Topics » Medical technology, Regulatory

Medical technology, Regulatory
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Regulatory front for June 17, 2020

June 17, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Chembio.
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Regulatory actions for June 17, 2020

June 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care.
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FDA icons

Back to ‘normal’? FDA adcom meets, but questions loom over others

June 17, 2020
By Mari Serebrov
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
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Avalon fetal monitor on expectant mother in hospital room

Philips launches wireless, wearable obstetrics monitor under FDA COVID-19 guidance

June 16, 2020
By Stacy Lawrence
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
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Multiple computer screens showing various views of ClewICU software

Clew snags EUA for COVID-19 predictive screening tool

June 16, 2020
By Meg Bryant
Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.
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Regulatory front for June 16, 2020

June 16, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, Klarity, Supernus, United Therapeutics.
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Regulatory actions for June 16, 2020

June 16, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Guard Medical, Infinity, Inmode, Smith+Nephew.
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Freestyle Libre 2 integrated continuous glucose monitor

FDA clears Abbott Freestyle Libre 2 for sale as integrated continuous glucose monitor

June 15, 2020
By Annette Boyle
The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks.
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Regulatory front for June 15, 2020

June 15, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for June 15, 2020

June 15, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Akili, Canon, Allergan, Medrhythms, Medtronic, Spectronrx, Venus.
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