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QUOTED.

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QUOTED. 8 April 2020. Carlos Nunez.

ResMed plans to double, even triple its production of ventilators, CPAP and BPAP machines to help fight the shortage of life-saving ventilators to treat COVID-19 patients. See what ResMed’s chief medical officer, Carlos Nunez, said about the company’s supply chain.

Quoted Respiratory

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

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

QUOTED. 3 April 2020. Minetta Liu.

Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.

Quoted Clinical Trials

QUOTED. 2 April 2020. Chris Whitty.

UK public health officials said recently that COVID-19 self-tests may soon be available to buy through Amazon or pharmacies. Here’s what Chris Whitty, Chief Medical Adviser to the UK government, said about the proposal.

Quoted United Kingdom

QUOTED. 1 April 2020. Bob White.

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.

Quoted Research & Development

QUOTED. 31 March 2020. US FDA.

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.

Quoted Regulation

QUOTED. 30 March 2020. Stephen Hahn.

President Trump on 27 March signed into law a $2.2tn COVID-19 stimulus package that provides $80m to the US Food and Drug Administration for emergency use authorization of medical products. See what FDA commissioner Stephen Hahn said about it here.

Quoted Legislation

QUOTED. 27 March 2020. US FDA.

Manufacturers of some medical face masks won't need US Food and Drug Administration clearance to sell their wares under an immediately in effect guidance document issued on 26 March. See what the FDA said about it here.

Quoted Regulation

QUOTED. 26 March 2020. Kevin Harper.

The American Telemedicine Association expects CMS to provide additional support for telemedicine to help curb the spread of COVID-19. See what the organization's director of policy, Kevin Harper, said about the potential future of telemedicine here.

Quoted Regulation

QUOTED. 25 March 2020. Jim Hackett.

Ford Motor Co. announced partnerships with GE Healthcare and 3M Co. to manufacture much-needed medical ventilators and respirators. See what Ford CEO and president Jim Hackett said about it here.

Quoted Manufacturing

QUOTED. 24 March 2020. Joseph Brennan.

US telehealth companies are seeing skyrocketing demand for devices and services. See what Joseph Brennan, a telehealth expert at Moonshot Health Consulting, said about it here.

Quoted Infectious Diseases

QUOTED. 23 March 2020. Joy Sturm.

President Donald Trump says he will invoke the Defense Production Act to spur the manufacture of needed medical devices and supplies during the COVID-19 pandemic. The move worries some in the device industry, says Joy Sturm, a partner in the Washington, DC, office of law firm Hogan Lovells.

Quoted Manufacturing

QUOTED. 20 March 2020. Paul Chrisp.

England’s health technology assessment body has eased back on a draft recommendation against using endovascular aneurysm repair (EVAR) on unruptured abdominal aortic aneurysms. See what Paul Chrisp, director of the Centre for Guidelines at NICE, had to say about the new guidance.

Quoted United Kingdom

QUOTED. 19 March 2020. Phil Roe.

The US government will study ways to reduce American manufacturers’ dependence on a foreign supply chains for devices and drugs under a bill introduced on 12 March by Sens. Lamar Alexander and Dick Durbin. Here’s what Rep. Phil Roe, R-TN, said about related House legislation.

Quoted Policy
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