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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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