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FDA retains right to observe accredited body evaluations in final guidance for ASCA pilot

Last updated: Sep. 24, 2020

The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is intended to foster med-tech regulatory harmonization, but stakeholders saw a number of issues with the September 2019 ASCA draft guidance.

BioWorld MedTech Regulatory U.S. FDA

Accuracy, utility of COVID-19 lateral flow tests questioned in the U.K.

BioWorld MedTech

LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot...

Total artificial heart being manufactured

Carmat's artificial heart receives CE mark

BioWorld MedTech

Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second...

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BioWorld

BioWorld briefs for Jan. 14.

Israel continues to shine as hub of med-tech innovation

BioWorld MedTech

In recent years, Israel has proven to be a hot spot for med-tech innovation. The country boasts more than 1,500 companies in the health care and life sciences...

Sarepta DMD phase II hangs in ‘balance’ as disparity in North Star leads astray

BioWorld

Sarepta Therapeutics Inc.’s miss on a key phase II ambulatory endpoint in its Duchenne muscular dystrophy (DMD) trial may have been caused by a dramatic disparity...