Abbott plans to deliver 30 million BinaxNOW prescription, at-home rapid tests in the first quarter of 2021; 90 million more in the second quarter.
Abbott announced on 16 December that the US Food and Drug Administration has issued emergency use authorization for BinaxNOW COVID-19 Ag Card Home, its 'virtually guided' at-home COVID-19 antigen test. Users receive step-by-step instructions about the sample collection process and guidance in reading and understanding the results via an app.
Abbott said it will bring BinaxNOW to the patient’s home at a cost of $25 for testing and service via its telehealth partner eMed
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
