Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
Researchers at Klick Labs Inc. reported using a person’s voice to predict chronic hypertension with a high degree of accuracy. Data published in IEEE Access, found the potential for advancing early detection of chronic high blood pressure, showcasing another novel way to harness vocal biomarkers for better health outcomes.
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.
Vericel Corp.’s Maci for repairing cartilage defects in the knee has been approved by the U.S. FDA via a supplemental biologics license application. Using a patient’s own cells cultured on a porcine collagen membrane, Maci Arthro is delivered arthroscopically and allows for repair of knee cartilage defects up to 4 cm2.
A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.
Edwards Lifesciences Corp. continued its recent acquisition streak with its buy of JC Medical Inc., a subsidiary of Genesis Medtech International. The sale included the intellectual property and commercial rights for the J-Valve system, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation.
In an earnings call, Asensus Surgical Inc. told shareholders it will have to file for bankruptcy if they do not approve the previously reported merger with Karl Storz Se & Co. KG.
Zimmer Biomet Holdings Inc. reported it will buy Orthogrid Systems Inc., a company that makes artificial intelligence-driven surgical guidance systems for total hip replacement for an undisclosed amount, and expects to complete the deal by the end of the fourth quarter of 2024.
Stryker Corp. continued its recent buying spree with the purchase of Molli Surgical Inc., a company that develops wire-free soft tissue localization technology for breast-conserving surgery. Styker said Molli’s offerings strengthen its advancing surgical solutions in breast cancer care.
Edwards Lifesciences Corp. said it has exercised its option to buy Innovalve Bio Medical Ltd., an early stage transcatheter mitral valve replacemen company, for $300 million in cash following its initial investment in 2017. Since that time, Edwards said Innovalve has demonstrated progress in its program with promising early clinical experience.