Oxford University startup Ultromics Ltd. has won the U.S. FDA's nod for its artificial intelligence (AI) image analysis system for diagnosing coronary artery disease. Called Echogo Core, the system is intended to serve as an aid to cardiologists in evaluating echocardiograms of patients referred with symptoms such as shortness of breath and chest pain. Ross Upton, co-founder and CEO of Ultromics, called the clearance a "watershed moment" for the company, which began developing its algorithm-based system in 2011 and was spun out of Oxford University in 2017. The next stage for the company is commercializing the product and bringing it to clinicians in the U.S. Ross said the company expects to launch the product in the beginning of next year. Read More
Urinary tract infections (UTIs) are a common reason for women to visit their doctor. While virtual doctor visits have been possible to detect UTIs, patient-reported symptoms typically have drove diagnoses. Now, Los Angeles-based Scanwell Health is bringing its at-home smartphone-enabled test and treatment service for UTIs to all 50 states. Scanwell said its offering its the first U.S. FDA-cleared urine testing app available over-the-counter without a prescription. Read More
An FDA advisory panel struggled at times to give the agency clear advice on the role of materials in device failures, but the panel nonetheless lent its support to the notion that device makers should disclose all materials used to fabricate device implants in product labels. Read More
Hand-held diagnostics don't come cheaply, and their applications remain somewhat limited. Abbott Laboratories' Istat portable clinical analyzer, for example, retails at about $15,000, with each individual cartridge costing hundreds of dollars apiece to measure each of roughly a few dozen blood gas, electrolyte, chemistry and hematology levels in few minutes from two to three drops of whole blood. Read More
Hemoalgae, from Cartago, Costa Rica, is moving forward with the extraction and development of molecules of hirudin, a peptide with anticoagulant properties, which impacts the biotech and med-tech sectors. Their uniqueness? Sourcing the anticoagulant hirudin from algae. Read More
For more than two decades, the BioWorld team has understood that there's a vital need to know to stay competitive, to bring your novel ideas forward through the long cycle of development, testing and commercialization. Now we've upgraded our presentation of news and analysis. On Nov. 19, we're migrating to a fantastic new platform. Read More
