Nanodx Inc. is readying for a U.S. pivotal trial of its nanowire biosensor technology. The company’s flagship product is designed to detect and quantify biomarkers proteins from a small fluid specimen of blood or saliva in less than four minutes and was developed in partnership with Skywater Technology Inc. and IBM Research. The privately held company is focusing on two clinical indications: traumatic brain injury (TBI) and COVID-19. Read More
Patients with chronic obstructive pulmonary disease (COPD) may soon have a new way to better manage their health without increasing doctor visits. Nuvoair AB reported that a trial in two U.S. locations showed that 80% of participants with COPD experienced a reduction in hospitalizations as well as improvement in quality of life using the company's integrated digital app and counseling program. Read More
As amounts raised through financings are significantly shy of last year, med-tech deals and M&As appear strong, with digital health dominating the landscape. Read More
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2. Read More
A pilot study of a novel, collagen-based substitute for donated corneal tissue has detected an unexpectedly strong efficacy signal in 20 patients with advanced corneal disease and has set the stage for a larger randomized control trial that could lead to regulatory approval. Fourteen of the phase I trial participants were legally blind prior to undergoing implantation of the device; none were at two years’ follow-up. Read More
Western Australia’s private investment group Tattarang has launched a new AU$250 million (US$173.6 million) investment fund called Tenmile that will invest in early stage Australian biotech and med-tech companies. One of Australia’s largest private investment groups, Tattarang is owned by the Forrest family and has five business divisions made up of real estate, agriculture, energy, mining and hospitality. Read More
The U.S. FDA published a draft guidance for hydrogen peroxide-based contact lens care products (HPCPs), which up until 1997 were seen as class III products requiring a PMA. However, this draft is a response to an increasing number of adverse events associated with these products, a problem that was the subject of a 2017 FDA advisory hearing. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antigua Medical, Caregility, Eko, Favor, Imaware, ITM, MD Office Solutions, Medimatrix, Mellingmedical, Microdrop, Positron Precision, Science 37, Syapse, Webinterstate. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cordx, Zavation. Read More
