Allara Health Inc. officially launched its diagnostic test for polycystic ovary syndrome (PCOS) this week, but word of mouth has already established a waitlist of more than 10,000 women. The diagnostic tool evaluates a full panel of hormonal and metabolic markers, which are used with patient-reported symptoms, to diagnose the increasingly common condition.

Jubliee Biotech Co. Ltd. is hoping to get FDA clearance with Jubiwatch, its smartwatch and medication management platform. “We aim to obtain FDA pre-submission between April and June 2022, and hopefully hit the U.S. market at the end of 2023,” Sung Kyoung Lee, CEO at Jubliee Biotech, told BioWorld.

Tilak Healthcare SAS has received €7 million (US$8.08 million) from investors to push commercialization of its mobile game and vision monitoring platform, Odysight. The CE marked class I device is prescribed by ophthalmologists to remotely monitor age-related visual impairment and includes daily visual tests to stimulate cognitive and visual abilities. A rollout of the mobile game has already commenced in France.

The Scottish government has signed a deal with digital therapeutics company Big Health Inc. to make a cognitive behavior therapy (CBT) platform for anxiety and insomnia available through the NHS. It makes Scotland the first country to provide a digital therapeutic for anxiety and insomnia nationally.

India is turning to digital means in a bid to manage illnesses within its borders, with both public and private corporations getting in on the action. The All India Institute of Medical Sciences Delhi (AIIMS), a public medical institute in the state of Delhi, has developed two mobile apps for patients with chronic mental illness and their caregivers. The first app is Shaksham, for patients with chronic mental illness, while another, called Disha, will be for patients who are undergoing their first such episode of symptoms.

The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.

TORONTO – A “silent epidemic” all but “ignored” by medical technology developers. That’s how Carlo Perez, founder and CEO of Swift Medical Inc., described the hesitancy of the industry to directly tackle chronic wound care through development of more advanced medical imaging and diagnostic systems. Undaunted, U.S. and Canadian investors have raised $35 million in series B funding to advance development and uptake of Swift Medical’s own AI-powered, digital wound care platform.

Happify Inc. launched Ensemble, a prescription digital therapy designed to treat patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD). The app joins several others that target both depression and anxiety, including the eponymous apps made by Woebot Health (Woebot Labs Inc.) and Youper Inc., although it is the only one that requires a prescription in the pack.

Myopia, or near-sightedness, is a growing public health problem, often beginning in childhood. Severe cases can lead to serious complications including cataract, glaucoma and retinal detachment. Now, Dopavision GmbH has raised a €12 million (US$14.2 million) series A round to advance its digital childhood myopia therapeutic aimed at nipping this lifelong problem in the bud.

Pear Therapeutics Inc. released nine-month, real-world data showing long-term reduction in costly health care utilization categories, including inpatient stays and emergency department visits, in patients with opioid use disorder (OUD) who utilize its Reset-O prescription digital therapeutic. The findings suggest that Reset-O could help to stabilize patient outcomes long-term when used in conjunction with outpatient treatment.