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COVID-19 Watch

Latest From Coronavirus COVID-19

US VP And CMS Chief Urge In-House Academic Hospital Labs To Share COVID-19 Data With HHS

US Vice President Mike Pence and Medicare administrator Seema Verma want academic and university hospital laboratories to send their de-identified COVID-19 test data results, daily, to the Department of Health and Human Services. Commercial and private labs are exempt from the request, as they already share their coronavirus test results with the government.

Policy Coronavirus COVID-19

COVID-19: Medtronic Shares Ventilator Specs Amid Multi-Industry Efforts To Increase Ventilator Production

Medtronic shares an open-source design for its ventilator to help mitigate the nation’s ventilator shortage for COVID-19 patients.

Coronavirus COVID-19 Safety

UK MHRA To Medtech: Check Before Applying For Non-COVID-19 Trials

The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these. 

Coronavirus COVID-19 Clinical Trials

Smiths Medical Ramps Up ParaPAC Ventilator Production For UK Order Of 10,000 Units

Smiths Medical is increasing paraPAC ventilator production from hundreds to thousands a month to fulfill 10,000 units as part of the Ventilator Challenge UK consortium.

United Kingdom Coronavirus COVID-19

Belgium Bans COVID-19 Antibody Self-Tests But UK Goes Ahead

While the UK is moving forward quickly to provide COVID-19 antibody self-testing, the Belgian government considers the tests not sufficiently accurate to be used in the pandemic.

Medical Device Europe

FDA To Relax Some Standards For Use Of Surgical Gowns, Gloves, Other Apparel During COVID-19 Crisis

The US FDA wants to expand the availability of surgical apparel – including gowns, hoods and examination gloves – for health care professionals to use for the duration of the COVID-19 public health crisis. That means the agency will “not object” to the use of gowns and gloves providing low-to-minimal protection, as long as they do not create an undue risk to patients or users.

Enforcement Policy

Battelle Decontamination System Gets EUA To Fight Respirator Shortage

The US FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.

Approvals Companies

Temporary Guidance Relaxes Oversight of Sterilizers, Disinfectant Devices, Air Purifiers

The US FDA published on 29 March an emergency temporary guidance that relaxes oversight of certain sterilizers, disinfectant devices and air purifiers intended to kill the SARS-CoV-2 virus.

Regulation Policy

Approval Of Medtronic’s Renal Denervation System Delayed By COVID-19

Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.

Clinical Trials Coronavirus COVID-19

German COVID-19 Testing Rate The Envy Of Others, With Demand Set To Climb

Germany has ramped up its COVID-19 testing capacity to 260,000 per week, and still has a relatively low death rate from the virus. The country's diagnostics industry says it is ready to play its part “24/7.”

Germany Policy

Quality Should Ride Shotgun As US Auto Makers Rev Engine On Making Ventilators

As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.

Quality Manufacturing

England's NICE To Focus On COVID-19 And Other Critical Therapies

The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.

Health Technology Assessment Coronavirus COVID-19
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