Illumina’s COVIDSeq Test enables qualitative detection of SARS-CoV-2 RNA from respiratory specimens.
Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators. But many firms in the medtech sector are not maximizing the opportunity to deliver regulated product information digitally.
COVID-19 is driving patients to seek telehealth solutions, and it won’t be a short-term boom.
It is the first federal approval for a test that uses saliva as the primary test biomaterial for COVID-19.
A discussion of the changing medtech markets and how companies can remain cognizant of potentially disruptive changes in their business and industry for future success in their product portfolios, services and relationships.
ECRI releases its top 10 list of health technology hazards for 2018.
The agency is seeking more participation among different genders, ages, races and ethnic groups.
Do regulators have a disincentive to approve medical devices?
Device companies can tap into a growing market that needs more cost effective healthcare services.
Discussing device problems can have a serious affect on patients. Physicians, manufacturers, and FDA should clarify their message to maintain trust.