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Clinical / R & D

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Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says

Quarantines, travel restrictions and supply chain interruptions are likely to cause "unavoidable protocol deviations" in ongoing clinical trials, the FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by COVID-19.

Coronavirus COVID-19 Clinical Trials Regulation

Clinical Trials

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Latest From Clinical Trials

Becton Dickinson, BioMedomics Collaborate On Rapid Serology COVID-19 Test

BD and BioMedomics will soon begin distributing a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.

Approvals Coronavirus COVID-19

ACC 2020: TAVR Matches Surgery In Two-Year PARTNER 3 Results

The two-year results from the PARTNER 3 trial showed transcatheter aortic valve replacement with Edwards Lifesciences' Sapien 3 system was statistically non-inferior to surgical valve replacement in low-risk patients. The one-year results from the trial had shown TAVR was superior to surgery in low-risk patients.

Clinical Trials Research & Development

Device Week, April 3, 2020 – New Telemonitoring Patch; Medtronic Delays Renal Denervation Approval

In this edition of the Device Week podcast, Medtech Insight managing editor Marion Webb discusses LifeSignals’ plans for a vital-sign monitoring patch that could help remotely monitor patients during the pandemic. Deputy editor Reed Miller highlights some important device trials presented at the American College of Cardiology online conference.

Device Week Clinical Trials
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New Technology

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Latest From Innovation

QUOTED. 7 April 2020. Surendar Magar.

California-based biosensor patch company LifeSignals Group plans to file for an emergency use authorization from the US FDA for a new patch that can monitor vital signs to help individuals decide when to seek the help of a health care provider. See what LifeSignals’ CEO Surendar Magar said about it here.

Quoted Digital Health

ACC 2020: TAVR Matches Surgery In Two-Year PARTNER 3 Results

The two-year results from the PARTNER 3 trial showed transcatheter aortic valve replacement with Edwards Lifesciences' Sapien 3 system was statistically non-inferior to surgical valve replacement in low-risk patients. The one-year results from the trial had shown TAVR was superior to surgery in low-risk patients.

Clinical Trials Research & Development

LifeSignals Plans To Market Biosensor Patch To Help Consumer Identify COVID-19 Symptoms

LifeSignals plans to soon launch a biosensor patch to consumers to help them monitor for potential symptoms of COVID-19. 

Coronavirus COVID-19 Digital Health
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Approvals

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Latest From Approvals

Trump Pushes Back On OIG Report That Hospitals Want Feds To Better Police Resources, Relax Regs

When asked about an inspector general report that found hospitals are struggling with tests and resources, and are looking to the federal government to help facilitate more efficient distribution of medical devices to fight the COVID-19 crisis, President Trump attacked the report as a political hit from an Obama holdover.

Regulation Coronavirus COVID-19

Becton Dickinson, BioMedomics Collaborate On Rapid Serology COVID-19 Test

BD and BioMedomics will soon begin distributing a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.

Approvals Coronavirus COVID-19

QUOTED. 6 April 2020. Bethany Hills.

Diagnostics company Bodysphere had to retract an announcement that it had received an emergency use authorization from the US FDA for a COVID-19 serologic test. See why Bethany Hills, an attorney with law firm Morrison & Foerster, says this may be a cautionary tale for other manufacturers.

Quoted Regulation
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