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BioWorld - Sunday, April 26, 2026
Home » Topics » Regulatory, Medical technology

Regulatory, Medical technology
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India’s restriction on API exports gives rise to more calls for U.S. drug, device manufacturing

March 3, 2020
By Mari Serebrov
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
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Synaptive Medical scores Canadian nod for Evry

March 2, 2020
By Liz Hollis
Synaptive Medical Inc., of Toronto, has secured Health Canada’s approval for Evry, the company’s superconducting head magnetic resonance imaging (MRI) system. The Evry system aims to provide imaging directly at the point of care in areas outside diagnostic imaging departments.
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With Brexit split, Australia ready with back-up plan for drugs and devices following transition

March 2, 2020
By Tamra Sami
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration (TGA) is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends on Dec. 31, 2020.
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FDA posts IIE guidance for clinical lab development of COVID-19 tests

March 2, 2020
By Mark McCarty
The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test.
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Regulatory front for Feb. 28, 2020

Feb. 28, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Costa Rican flag, economy/growth puzzle pieces

Costa Rica designs tailor-made programs to train manpower for the med-tech sector

Feb. 28, 2020
By Sergio Held
SAN JOSE, Costa Rica – Two decades ago, the Costa Rican economy was basically an agriculture-based economy. Since then, the tiny Central American country has emerged as the second-largest med-tech exporter in the region as well as an eager partner and supplier of skilled manpower.
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Regulatory front for Feb. 27, 2020

Feb. 27, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: King Systems.
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FDA wraps up CLIA-related guidances for 510(k) diagnostics

Feb. 27, 2020
By Mark McCarty
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
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Speakers make case for home-use ultrasound with help of AI

Feb. 26, 2020
By Mark McCarty
The second day of the FDA workshop on artificial intelligence (AI) in health care featured several interesting proposals, including that AI will be used in health care without the aid of a health care professional. John Martin, chief medical officer at Butterfly Network Inc., of Guildford, Conn., said the time is ripe for AI-assisted ultrasound in the home, which he claimed could reduce rehospitalizations in heart failure, one of the holy grails in U.S. government efforts to restrain health care spending growth.
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Regulatory front for Feb. 26, 2020

Feb. 26, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Livanova.
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