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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard.
The digital therapeutics market has surged during the pandemic and looks likely to markedly change health care long after the current crisis abates. The need for distance, limited in-person appointments, increased stress and mental health issues, and a more relaxed U.S. FDA approach have created the ideal environment for the rollout of therapies patients can use from home on their own time. Increasingly, clinical trials demonstrate the effectiveness of the new options and users praise the convenience.
PARIS – Tilak Healthcare SAS is signing an ophthalmology partnership agreement with Novartis AG from Basel, Switzerland, to expand international distribution of its vision monitoring technology, Odysight.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cerenion, Ecolab, Integrum, Occlutech.
Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis.
In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Anitoa, Binx Health, Ellume, Exero Medical, Genetesis, Horiba, Roche, Seaspine, Switch Health.
It might not have helped Iron Man survive use of the Infinity gauntlet, but for individuals with chronically iron-poor blood, Sanguina Inc. ’s new mobile app could be a lifesaver. Atlanta-based Sanguina released Anemocheck Mobile, an app that measures hemoglobin levels, for the Google Play Store and will shortly add the app for iOS. Anemocheck analyzes a photo of the user's fingernail beds and provides the hemoglobin level on the screen. Hemoglobin levels provide the most common measure of anemia.
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