Months after revealing a U.S. FDA nod for the Rhinaer Stylus to treat chronic rhinitis, Aerin Medical Inc. reported the closing of a $48 million equity financing. In addition, the company revealed that Matt Brokaw, who has deep experience in the ear, nose and throat (ENT) space, has come on board as president and CEO. Read More
The COVID-19 pandemic has spurred a considerable amount of testing innovation, including more extensive use of saliva as a medium for detection of pathogens. The U.S. FDA has announced an emergency use authorization (EUA) to Yale School of Public Health for the Salivadirect testing protocol that requires no extraction of the SARS-CoV-2 virus’s RNA, a feature that Assistant Secretary for Health Brett Giroir said is “yet another testing innovation game changer that will reduce demand for scarce testing resources.” Read More
Transit Scientific LLC’s XO Cross Microcatheter platform was used in its first cases worldwide last week following its May 2020 clearance by the U.S. FDA and showed improved control and imaging. The company designed the platform to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions such as late-stage peripheral artery disease (PAD) and critical limb ischemia (CLI). Read More
HONG KONG – China’s Arctic Vision (Shanghai) Biotechnology Co. Ltd. has entered an exclusive deal with New York’s Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Under the deal, Arctic Vision will commercialize Eyenovia’s Micropine and Microline formulations in Greater China and South Korea in exchange for $45.75 million in upfront payments and additional milestone and royalty payments. Read More
LONDON – A large scale population study has shown that home self-testing with low-cost lateral flow diagnostics is a valid way of tracking the COVID-19 pandemic. A total of 105,651 people across the U.K. tested themselves for SARS-CoV-2 antibodies with a fingerprick blood test as part of the REACT (REaltime Assessment of Community Transmission) study. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Cartiva, C.R. Bard, Stryker ENT. Read More
Keeping you up to date on recent developments in cardiology, including: Assessing stroke risk via metabolic syndrome; Under pressure; While less deadly, atrial fibrillation still raises concerns. Read More
