Forgot password?
Sign up today and your first download is free.

Medical Devices

May 06, 2020 | Daily News

FDA released a temporary guidance Wednesday (May 6) requiring that manufacturers notify the agency of any significant disruption in the medical device supply chain during a public health emergency, in a bid to mitigate devices shortage amid the COVID-19 crisis.

May 06, 2020 | Daily News

Health care technology company Aetion is calling for FDA to implement a cloud-based real-world evidence platform with robust data governance to allow for data queries, archiving, access and aggregation.

May 04, 2020 | Daily News

Following criticism that hundreds of COVID-19 serology tests, some of them allegedly fraudulent, have come to market without any oversight, FDA on Monday gave commercial manufacturers of currently marketed COVID-19 serology tests 10 business days to submit Emergency Use Authorization requests.

April 29, 2020 | Daily News

FDA has set up an “umbrella” pathway for COVID-19 serology tests that allows developers to qualify for Emergency Use Authorization if their tests are independently validated by a designated government agency, such as the National Cancer Institute, and meet certain performance metrics, Timothy Stenzel, head of FDA’s Office of Health Technology, said during a virtual town hall on Wednesday (April 29).

April 29, 2020 | Daily News

FDA recently released a temporary enforcement policy stating it does not intend to pursue regulatory action over distribution of unapproved computerized behavioral therapy and other digital health devices during the COVID-19 pandemic.

April 28, 2020 | Daily News

Key House lawmakers released a concept paper Monday (April 27) outlining FDA and clinical trial reforms they want included in the second iteration of the 21st Century Cures Act, though they say some of the proposals could be wrapped into the next rounds of COVID-19 relief legislation this year.

April 28, 2020 | Daily News

The American Medical Association on Tuesday (April 28) pressed HHS to ensure the results of COVID-19 serology tests, which check blood for disease antibodies, aren’t used to make personal decisions on physical distancing or to attempt to determine immunity to COVID-19.

April 27, 2020 | Daily News

The House oversight committee is concerned that FDA lacks data on the validity of COVID-19 antibody tests, coming as the White House lays plans to rely on serology test results to reopen the economy.

April 21, 2020 | Daily News

U.S. Trade Representative Robert Lighthizer should “immediately and broadly” lift Section 301 tariffs on imports needed to manufacture medical products being used to combat the coronavirus outbreak, Sens. Tom Carper (D-DE) and Pat Toomey (R-PA) said this week.

April 21, 2020 | Daily News

FDA on Tuesday (April 21) cleared the first at-home diagnostic test for COVID-19 by re-issuing emergency use authorization to Laboratory Corporation of America’s (LabCorp’s) reverse transcriptase polymerase chain reaction test, which the agency says should be available in most states in the coming weeks.

April 17, 2020 | Daily News

As the administration resists Democrats’ calls to do outreach on the existing special enrollment periods for Affordable Care Act coverage, Facebook on Thursday (April 17) launched a campaign urging Americans who have lost their jobs to visit healthcare.gov to check their eligibility.

April 17, 2020 | Daily News

FDA Commissioner Stephen Hahn said Thursday (April 16) the agency continues to meet its user fee commitments but signaled that could change due to staffers focusing on COVID-19, coming as FDA is unable to hold in-person user fee negotiations and has postponed indefinitely its medical device user fee meeting.

April 16, 2020 | Daily News

FDA cleared the way for hospitals to dispense at-home blood glucose monitoring devices to COVID-19 patients so they can self-test while in the hospital, which device companies and FDA say can reduce burden on, and risk to, health care workers while also protecting diabetes patients who have compromised immune systems.

April 10, 2020 | Daily News

FDA granted Emergency Use Authorization for a blood purification system to treat COVID-19 patients who are at least 18 years old and have been admitted to the intensive care unit with confirmed or imminent respiratory failure, the agency announced Friday (April 10).

April 10, 2020 | Daily News

FDA granted Emergency Use Authorization to STERIS Corporation’s N95 decontamination system, marking the second time in the past week the agency has granted EUA to a mask sanitization device.

April 08, 2020 | Daily News

Public health and policy experts say at-home COVID-19 infection and antibody test kits need to be developed rapidly and disseminated broadly so people with mild symptoms can take action to self-isolate and access telemedicine while people with antibodies and potential immunity to the disease can resume normal activities.

April 06, 2020 | Daily News

FDA’s latest guidance on sterilization and disinfecting devices can be applied to a broad swath of decontaminating equipment, including those used in homes and businesses, and manufacturers are scrambling to meet the guidance’s requirements so equipment can be deployed quickly, according to Paul Krupin, the creator of search tool Presari.

April 03, 2020 | Daily News

New York Gov. Andrew Cuomo (D) will sign an executive order allowing the state to take ventilators and personal protective equipment from hospitals around the state that don’t have an immediate need and redeploy those resources to hospitals that need them for COVID-19.

April 02, 2020 | Daily News

Anthem said Wednesday (April 1) it would waive cost-sharing for all treatments related to the COVID-19 diagnosis through May 31, the fourth major insurer to make such a decision in recent weeks.

March 30, 2020 | Daily News

After pushback from Ohio Gov. Mike DeWine (R) and President Donald Trump, FDA on Sunday (March 29) authorized Ohio-based nonprofit Battelle Memorial Institute’s decontamination system for use in sanitizing as many as 160,000 N95 masks for reuse.