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The 3 steps for getting visual field defects checked by Heru

Heru registers AI vision test with FDA, begins commercialization pilot

Dec. 28, 2020
By Mary Ellen Schneider
Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.
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Laptop, stethoscope, medical icons, health professional
FDLI Enforcement Conference

FDA enforcement discretion for digital health a source of uncertainty for industry

Dec. 28, 2020
By Mark McCarty
The U.S. FDA has exercised a considerable degree of enforcement discretion during the COVID-19 pandemic, particularly when it comes to digital health. However, Christine Bump, principal at Penn Avenue Law & Policy, said that this very discretion has an uncertain shelf life and advised industry to remain compliant with the regulations as much as possible to avoid unnecessary enforcement actions by federal agencies.
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U.S. Capitol building

Walden looks at the challenges ahead, milestones behind

Dec. 23, 2020
By Mari Serebrov
In an exclusive interview with BioWorld on the challenges facing a deeply divided Congress and some of the highlights of his years in the U.S. House, retiring Congressman Greg Walden (R-Ore.) said that once the COVID- 19 pandemic is over, federal policymakers should hold a summit with officials from states and major cities to look at a new preparedness partnership that would ensure the availability of strategic medical supplies.
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U.S. Capitol and $100 bills

Congress gives NIH, FDA slight funding bump for fiscal 2021

Dec. 22, 2020
By Mari Serebrov
After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding.
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FDLI Enforcement Conference

FDA will advise device makers on EUA transitions, but scrutiny will be high post-pandemic

Dec. 21, 2020
By Mark McCarty
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
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U.S. Capitol building

Grassley may advance legislation in 2021 to tighten FCA enforcement

Dec. 18, 2020
By Mark McCarty
False Claims Act (FCA) litigation is one of the more potent weapons used to corral life sciences companies that stray out of legal bounds in the U.S. Jaime Jones, a partner in the Chicago office of Sidley Austin LLP, told BioWorld that Sen. Chuck Grassley (R-Iowa), long a legislative watchdog, has several notions about how the statute might be tweaked.
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Binaxnow COVID-19 Ag Card Home Test

Abbott’s Binaxnow COVID-19 rapid test authorized for home use

Dec. 17, 2020
By Meg Bryant
As COVID-19 cases surge across the U.S., there is growing demand for greater access to testing to rein in the pandemic. On Wednesday, the U.S. FDA granted an emergency use authorization (EUA) to Abbott Laboratories for at-home use of the company’s Binaxnow COVID-19 Ag Card Home Test. Abbott has teamed up with Miami-based telehealth provider Emed to distribute and administer the tests, with an expected 30 million in the first quarter of 2021.
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