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Clinical / R & D

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Study Shows Rapid Adoption Of Robotic Assistance For Unproven Procedures

The authors of a large cohort study of the uptake of robotic-assisted surgery in Michigan hospitals argue that the rapid adoption of robotic techniques is not supported by existing clinical evidence.

Clinical Trials Research & Development Safety

Clinical Trials

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Latest From Clinical Trials

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Policy Approvals

J&J Has Big Plans For Robotic Surgery In 2020

The company’s leadership discussed its recent investments in robotic surgery technology during Johnson & Johnson’s 2019 fourth-quarter earnings call on 22 January. The company will provide more information on its robotic surgery platforms at its investors meeting in May in New York.

Robotic Surgery Companies

Study Links Paclitaxel To Lower-Leg Amputations

New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.

Research & Development Medical Device
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New Technology

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Latest From Innovation

Device Week, 24 January 2020 – Trends In Breakthrough Medical Devices

On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.

Device Week Review Pathway

J&J Has Big Plans For Robotic Surgery In 2020

The company’s leadership discussed its recent investments in robotic surgery technology during Johnson & Johnson’s 2019 fourth-quarter earnings call on 22 January. The company will provide more information on its robotic surgery platforms at its investors meeting in May in New York.

Robotic Surgery Companies

2019 Device Approvals Review: Original PMAs Up, De Novos Down

The US FDA approved fewer novel devices in 2019 than in 2018, despite a slight increase in original PMA approvals. De novo clearances were down significantly after four straight years of increases, while panel-track PMA supplements and 510(k) clearances also declined from the 2018 totals.

Approvals Innovation
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Approvals

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Latest From Approvals

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Policy Approvals

Device Week, 24 January 2020 – Trends In Breakthrough Medical Devices

On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.

Device Week Review Pathway

QUOTED. 24 January 2020. Megan McSeveney.

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Quoted FDA
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