The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks. Read More
Royalty deals by an investor into a particular pharmaceutical company program are not unheard of. This structure allows the investor to secure a portion of that specific anticipated upside, while enabling the pharma to fully fund R&D for that program without having to sacrifice other priorities to do so. Read More
Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke. Read More
PERTH, Australia – On the heels of an AU$5 million ($US3.47 million) capital raise, digital health company Respiri Ltd. is preparing to launch its digital wheezo asthma measurement device in Australia as it transforms itself from a device manufacturer to an eHealth software as a service company (SaaS). Melbourne-based Respiri received its first batch of 500 wheezo devices in March, and the company plans to deploy them in Australia this quarter. Read More
CAJICA, Colombia – Sales of breast implants have been badly hurt by the COVID-19 pandemic but one Costa Rica-based firm that makes them expects a rapid return to normal, thanks in part of the fact that many procedures are done in private clinics and relatively few people have canceled procedures. Sales of breast implants have been badly hit by the COVID-19 pandemic as elective surgeries in most countries were put off. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biolinq, Dariohealth, January.ai, One Drop. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Berry Genomics, Biospherix, Dariohealth, Genetron, Hawkeye Systems, Htg Molecular Diagnostics, Nanotronics, Patientsafe Solutions, Personalis, Royal Philips, Sexton Biotechnologies, Sorrento Therapeutics, Terramera, Thermo Fisher Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Akili, Canon, Allergan, Medrhythms, Medtronic, Spectronrx, Venus. Read More
Keeping you up to date on recent developments in cardiology, including: Assessing who’s at risk for heart rhythm disorders; Rewiring the heart to prevent recurrent fainting spells; Understanding link between COVID-19, cardiovascular diseases. Read More
