Truvian Sciences uses 7 drops of blood to produce lab accurate results in 20 minutes for a full suite of health tests but it has competitors both at home and abroad as it seeks to take on traditional lab testing providers like Quest Diagnostics and LabCorp.
FDA approval would set a molecular test apart, said Vince Miller, Foundation Medicine’s chief medical officer. “CLIA is the floor, New York State is a number of floors above that and the FDA is the penthouse.”
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A look at the advantages of different engineering models that in vitro diagnostic companies should consider adopting to improve production.
Because in vitro diagnostics are so integral to patient care, particularly for oncology, developers must be aware of how quality and efficacy data pertaining to their device will be used.
Which in vitro diagnostics are filling providers’ needs? Are they deficient in a performance characteristic that your IVD will improve upon or have you developed a new method that is more cost-efficient?
Global demand for home healthcare services will exceed a market value of $391 billion by 2021. Diagnostics equipment, including IVDs, account for more than one-third of the overall home healthcare equipment market and that share is expected to grow.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The European medtech market is worth about 100 billion euros (that’s about $132.2 billion if you’re playing at home, folks) and poised to grow about 5 percent a year, according to a new infographic from MedTechWorld. More than nine out of 10 are SMEs and the IVD market there alone accounts for more than 10 […]