Today, 340 companies signed a letter sent to Congress to urge leaders to make COVID-19-related telehealth flexibilities permanent. Representing all 50 states, Washington, D.C., and Puerto Rico, the signees are seeking to stop the potential for telehealth flexibilities to disappear, should Congress fail to act before the COVID-19 public health emergency expires, according to a […]
AdvaMed’s Whitaker calls for pandemic cooperation
Preparation for future pandemics will require closer cooperation between the medtech industry and the U.S. government, according to Scott Whitaker, CEO and president of the trade group AdvaMed. In an interview on the DeviceTalks Weekly podcast, Whitaker laid out steps he believes the federal government and medtech industry must take, including addressing medical device and […]
Hologic to launch new COVID-19 diagnostic across U.S.
Hologic (NSDQ:HOLX) announced late this afternoon that it will launch a second high-throughput molecular diagnostic test for the coronavirus (SARS-CoV-2). Investors reacted by sending shares in HOLX up 8.27% in after-hours trading. The Marlborough, Mass.-based company said it aims to produce at least 1 million Aptima tests per week to run on more than 1000 of […]
Could old ventilators be a secret weapon against COVID-19?
A pair of medtech industry veterans has formed a not-for-profit corporation to obtain and repair used ventilators for patients fighting COVID-19. Co-Vents has six FDA-approved and ISO-certified ventilator service centers lined up to do the work in New Jersey, Tennessee, California, Illinois and Georgia, according to co-founder Michael Raymer. The organization is seeking decommissioned Puritan Bennett, […]
Mesa ships 10,000 COVID-19 rapid tests
Mesa Biotech announced today that it is shipping 10,000 of its Accula SARS-CoV-2 molecular rapid point-of-care tests this week for detecting COVID-19. The San Diego-based company’s palm-sized testing platform is designed to enable “near-patient” testing outside a central laboratory with diagnostic results in 30 minutes. Accula uses reverse transcription polymerase chain reaction (RT-PCR) technology to […]
Hospital survey reveals front-line needs, desperate measures
Hospitals across the U.S. have begun resorting to unorthodox means of replacing or sanitizing personal protective equipment (PPE) and atypical sourcing of PPE and other supplies needed to fight the coronavirus pandemic, according to a government survey. The Department of Human Services’ Office of the Inspector General (OIG) conducted the random survey of 323 hospitals […]
Trump uses DPA to boost supplies to certain ventilator manufacturers
President Donald Trump yesterday invoked the Defense Production Act to reduce supply-chain problems for certain manufacturers to produce ventilators. In the executive order, the president gave the secretaries of the departments of Health & Human Services and Homeland Security the power to secure materials for General Electric (NYSE:GE), Hillrom (NYSE:HRC) , Medtronic (NYSE:MDT), ResMed (NYSE:RMD), Philips (NYSE:PHG) and Vyaire Medical. Ventilator […]
AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech […]
Everlywell, Nurx to offer at-home COVID-19 tests
Home testing company Everlywell said today that it will launch a home test kit with telehealth diagnosis for COVID-19 on Monday. The Austin, Texas-based company said it will release 30,000 tests immediately and is working with multiple labs to have testing and diagnosis capacity for a quarter of a million people weekly. Consumers who have […]
Hologic gets U.S. funding for coronavirus test kit
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is offering advanced development support to Hologic (NSDQ:HOLX) for a molecular diagnostic test for coronavirus (COVID-19). Marlborough, Mass.-based Hologic’s test is the first coronavirus product selected for development through ASPR’s biomedical advanced R&D authority streamlined selection process (BARDA), […]
Senate panel approves HHS nominee Azar
The Senate finance committee has approved president Donald Trump’s nominee for chief of the Dept. of Health and Human Services, Alex Azar. The former drug company executive is expected to be confirmed by the full Senate. If confirmed, Azar will succeed Tom Price, who was forced out after reports from Politico revealed he often used pricey charter […]
