No device-related warning letters were released by the US FDA the week of 31 March.

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

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. 

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.

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. See what the agency said about it here.

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.

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.

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.

Medtronic is publicly sharing design specifications for its PB 560 ventilator to help the global multi-industry effort devise options for rapid ventilator manufacturing. See what Bob White, president and executive VP for Medtronic’s Minimally Invasive Therapies Group, said about it here.

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

Belgian start-up miDiagnostics has closed a €14m investment round to accelerate development of its silicon-chip-based diagnostics platform. The company believes the blood analyzer could deliver rapid test results in multiple settings.

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.

Theradaptive's “paint-like” regenerative therapeutic can be applied to any device to promote bone regrowth or regenerate tissue.

In a 28 March FAQ document, the US agency cautions manufacturers on the 3D printing of medical devices to address the shortage of ventilators and other medical supplies during the coronavirus pandemic.

Medtronic is publicly sharing design specifications for its PB 560 ventilator to help the global multi-industry effort devise options for rapid ventilator manufacturing. See what Bob White, president and executive VP for Medtronic’s Minimally Invasive Therapies Group, said about it here.

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

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.

Butterfly Network is disseminating the lessons from China and Italy about the poential value of lung ultrasound in the management of COVID-19 patients with respiratory disease.

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

UK engineering firm Dyson, best known for its vacuum cleaners, fans and hand driers, plans to make 10,000 specially designed ventilators under a UK government contract.