Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam.

The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.

Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.

The story of how pigmentation affects the accuracy of pulse oximetry is still in play in the U.S. even though the FDA issued guidance on the subject in 2013, but the latest advisory hearing on the subject has added a new confounder to the story.

Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law.

The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang.

In what represents its first patenting, Copenhagen, Denmark-based HEI Therapeutics ApS reported seeking patent protection for a point-of-care or home monitoring solution, which enables personalized treatment for hypothyroidism.

A blood test developed by Datar Cancer Genetics Inc. for the detection of glial malignancies (GLI-M) could be a breakthrough for the diagnosis and treatment of brain cancer, according to a study published recently in the International Journal of Cancer.

In a post-pandemic world, South Korean molecular diagnostics firm Seegene Inc. is looking to ignite a new paradigm in the diagnostics business. Seoul-based Seegene is rolling out a new strategy of open innovation under its newfound initiative coined the “SG Onesystem,” which pledges to not only accelerate global partnerships for novel diagnostics but also “free the world of all disease.”

Inventors affiliated with Nirsense LLC, are designing somatic and cerebral oximetry devices using functional near-infrared spectroscopy (fNIRS). They have filed for patent protection of wearable systems capable of detecting both optical and non-optical biometric properties of a user to determine their cognitive state.