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BioWorld - Thursday, January 22, 2026
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
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Regulatory front for April 6, 2021

April 6, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
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Regulatory actions for April 6, 2021

April 6, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
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Patent law book and gavel

Proposed NIST rule escalates debate over Bayh-Dole march-in

April 6, 2021
By Mari Serebrov
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
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European Commission headquarters

Europe gears up for MCMs of the future

April 6, 2021
By Mari Serebrov
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.
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Device image

Orthofix gets approval for Construx 3D cervical spacer

April 5, 2021
By Greg Goth
The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth.
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Regulatory front for April 5, 2021

April 5, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
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Regulatory actions for April 5, 2021

April 5, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Electrocore, Orthofix, Surgical Information Sciences, Vysioneer.
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Costa Rican flag, economy/growth puzzle pieces

Costa Rica leads Central America in med-tech production, exports

April 2, 2021
By Sergio Held
CAJICA, Colombia – The tiny Central American country of Costa Rica continues to cement its position as Latin America’s med-tech powerhouse after experiencing double-digit growth in exports in the first two months of the year, according to data released by Procomer, the country's exports promotion agency. “These numbers become more relevant when detailing that medical devices and precision equipment represent, for the third consecutive year, the country's main export, which had double-digit growth of 23%, thus representing 36% of the exports of the country,” the Costa Rican government said.
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Regulatory actions for April 2, 2021

April 2, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-X Imaging, Quidel.
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Regulatory front for April 2, 2021

April 2, 2021
By Meg Bryant
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Infections associated with reprocessed urological endoscopes under investigation.
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