MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Report: FDA promise of 1 million coronavirus tests this week unattainable

Report: FDA promise of 1 million coronavirus tests this week unattainable

By

(Image from the CDC)

The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times.

FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would broaden their capacity to perform those tests, the Times report said.

The agency on Feb. 4 authorized the emergency use of a coronavirus test at the request of the Centers for Disease Control and Prevention (CDC). That test is manufactured by Integrated DNA Technologies, but increased production does not affect laboratories’ capacity to conduct the testing, the Times reported. New guidance the FDA issued on Feb. 29 allows any CLIA-certified, high-complexity laboratory to go through the process to become certified to test.

Scott Becker, CEO of the Association of Public Health Laboratories, said on Saturday that his organization expects public health laboratories will have the capacity to conduct 10,000 tests a day by the end of this week.  On Monday, Becker dialed that back, saying that labs can conduct about 100 tests per day, but that only half of them have the capacity to do so, the Times reported.

An apparent manufacturing defect in the initial tests rolled out by the CDC has caused a delay in upping the supply of tests, according to a report by Politico. The U.S. Department of Health and Human Services is  investigating the problem.

 

In case you missed it

RSS From Medical Design & Outsourcing

  • How to choose the right printing technology for UDI codes
    UDI labeling can identify medical devices through their distribution and use. The deadline for labeling Class 1 and unclassified devices is coming up. Tim Kearns, Videojet Technologies Whether you are expanding the production of medical devices already subject to Unique Device Identification (UDI) requirements or finishing your plan to meet the FDA’s UDI requirements for… […]
  • 3 medtech execs make EY entrepreneur finalist list
    A trio of Minnesota medtech business leaders has landed on the finalist list for EY Entrepreneur of the Year 2021 Heartland. Executives from AbiliTech Medical, Minnesota Rubber & Plastics and TSI rank among the 36 finalists from Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota and South Dakota. The finalists were selected by a panel of… […]
  • U.S. Supreme Court kicks Arthrex case back to patent board
    The U.S. Supreme Court ruled today that Patent Trial and Appeal Board judges are unconstitutionally appointed, but that greater supervision by the PTAB director would solve the problem. The opinion in the case followed a 2019 appeals court ruling in the closely watched patent spat between Arthrex and Smith+Nephew (NYSE:SNN). In the original lawsuit, Smith+Nephew and ArthroCare (which Smith+Nephew acquired… […]
  • Contract manufacturers fuel medtech expansion in Costa Rica
    Medical device manufacturing is flourishing in the Central American country, spurred by a host of incentives. This year is seeing a wave of expansions by medtech contract manufacturers in Costa Rica. Medtech OEMs have made the Central American company a manufacturing hub since the 1990s. Major companies operating there include Abbott, Bayer, Boston Scientific, Cardinal… […]
  • Purdue researchers develop biosensor for use during surgery
    Surgeons may soon be able to identify critical regions in tissues and organs during surgery using a biosensor recently developed at Purdue University. The biosensor can be printed in 3D using an automated printing system and allows for simultaneous recording and imaging of tissues and organs during surgery, according to its creator, Chi Hwan Lee.… […]
  • Amcor adds heat seal coating for medtech packaging
    Amcor has introduced a new heat seal coating for medical-grade DuPont Tyvek and paper packaging applications. The Buffalo Grove, Ill.-based company designed this next-generation coating technology to deliver enhanced performance features for healthcare applications. Amcor will produce the new coating, ACT2100, in multiple locations worldwide to offer customers the flexibility to receive supply from the… […]
  • Latest iCad 3D mammography AI gains CE mark
    iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level and approximately 40% faster processing on the… […]
  • Device could reduce chemotherapy-induced pain
    Researchers in Singapore have partnered with Paxman Coolers (U.K.) to develop a device to prevent or reduce numbness and pain caused by chemotherapy. Chemotherapy-induced peripheral neuropathy (CIPN) is a severe side-effect of chemotherapy drugs called taxanes, which are used to treat common cancers such as breast, lung, ovarian and stomach cancer. CIPN affects about 1.4… […]
  • What medtech’s top executives learned from their dads
    For better or worse, parents including dads play a major role in who we become. With Father’s Day approaching in the U.S., Medical Design & Outsourcing and MassDevice reached out to some of medtech’s top executives to ask what they learned from their dads. Here’s what they said: “My father built a business in the… […]
  • FDA issues docs on medtech remanufacturing, servicing
    The FDA has issued two documents to help distinguish between remanufacturing and servicing of medical devices. One is a draft guidance written to clarify the activities that likely constitute the remanufacturing of a device. The other is a discussion paper on cybersecurity and medtech servicing. The guidance also describes the FDA’s current position on remanufacturing,… […]
  • HelixBind wins $3M grant for sepsis test
    HelixBind announced today it has landed a $3 million federal grant to help develop a test to diagnose bloodstream infections associated with sepsis. The FDA granted Breakthrough Device Designation to the RaPID/BSI test and platform in 2020. Boxborough, Mass.-based HelixBind’s RaPID platform can provide definitive identification and characterization of infections directly from a blood draw… […]