Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market. Read More
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs. Read More
Esco Lifesciences Group Ltd. has closed what it claims to be the largest private fundraising round by an Asia-based life sciences tools company. The Singapore-headquartered life sciences product company raised $200 million in an oversubscribed series A and crossover round. The financing was led by Vivo Capital and Novo Holdings A/S, with participation from new investors, including China Investment Corp. and Singapore-based global investor EDBI. Read More
With the rollout of its Avagen test, Avellino Lab USA Inc. hopes to see a significant change in the diagnosis and management of keratoconus, a common cause of blindness. The test quantifies the risk of keratoconus and definitively diagnoses other corneal dystrophies, which are frequently misdiagnosed or undiagnosed until late in their development, when treatment is less effective and vision already impaired. Read More
With the U.S. launch of the first deployable airborne COVID-19 detection system, Bioflyte Inc. is working to provide effective ways to sample the air and deliver results within an hour. The Sentinel integrated solution aims to prevent widespread infection in schools and workplaces. Read More
Borrowing a chapter from venture capitalists, the U.S.’ Biomedical Advanced Research and Development Authority (BARDA) is partnering with the nonprofit Global Health Investment Corp. (GHIC) to accelerate the development and commercialization of medical technologies and products needed to respond to or prevent future pandemics and other public health emergencies. Read More
New hires and promotions in the med-tech industry, including: Avisa Diagnostics, HD Medical, Helius Medical, Nuvo Group, Rabble Health, Vericel, Zenflow. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytovale, Electrocore, Medtronic, Naveris, Sysmex Inostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akumin, Amgen, Apollo Medical Holdings, Arcline Investment Management, Brainsway, Cantel Medical, Cardiofocus, China Grand Pharmaceutical, Cohere Health, Health Care Services, Hyfe AI, Mercy Health, Obviohealth, Oncodisc, Pavmed, Philips, Qiagen, Quest Diagnostics, Resolution Medical, Steris, Sun Clinical Laboratories, Tetrascience, Thermo Fisher Scientific, Veris Health, Vori Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognoa, Edwards, Sorrento. Read More
