It might not have helped Iron Man survive use of the Infinity gauntlet, but for individuals with chronically iron-poor blood, Sanguina Inc. ’s new mobile app could be a lifesaver. Atlanta-based Sanguina released Anemocheck Mobile, an app that measures hemoglobin levels, for the Google Play Store and will shortly add the app for iOS. Anemocheck analyzes a photo of the user's fingernail beds and provides the hemoglobin level on the screen. Hemoglobin levels provide the most common measure of anemia. Read More
Corrective and preventive action (CAPA) has a long and difficult history where med tech is concerned. Kathryn Merrill, the global quality/regulatory program director for Medtronic plc, of Dublin, said on a recent webinar that one of the main sources of uncertainty is that many in industry are not clear as to which circumstances dictate that a CAPA should be opened. Read More
TORONTO – The Medipines AGM100, which was developed by Orange County, Calif.-based Medipines Corp. to detect respiratory impairment caused by chronic obstructive pulmonary disease (COPD), has been recruited in the fight against COVID-19 in Canada. Described by company CEO and coinventor Steve Lee as “the world's first noninvasive lung monitor for gas exchange measurement,” the device is undergoing advanced testing. Read More
A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup. Read More
HONG KONG – Big pharma and venture capital firms are increasingly focused on early-stage companies and digital solutions, judging by the interest shown by participants at Phar-East 2020. Much of the talk during the third and final day of the virtual conference that started Dec. 8 was focused on the business side of the health care space, and the undertones were definitely bullish. Read More
PARIS – Cardiawave SAS has been granted authorization by the French National Agency for Medicines and Health Products Safety to extend its clinical trial in France and treat patients with calcific aortic stenosis (AS). Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USTR seeking input on nations with poor IP protections; NICE sticks with ABI to evaluate PAD; Health Canada to extend COVID-19 flexibilities. Read More
New hires and promotions in the med-tech industry, including: Axonics, Edigene, Envision Healthcare, Guardant Health, Robocath, Tandem Diabetes Care. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Activepure Technologies, Aditx Therapeutics, American Bio Medica, Ashvattha Therapeutics, Babylon Health, Builtspace, Diabeloop, Efemoral Medical, Eurofins Technologies, GE Healthcare, Hummingbird Bioscience, Insightec, Lifescan, Luminultra, Mymedbot, Novacyt, Novocure, Oncimmune, Pacific Biosciences, Roche, SonALAsense, Tempus Labs, Todos Medical, Variscite, Welldoc. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avelas Biosciences, Foldax. Read More
Keeping you up to date on recent developments in cardiology, including: Genes influencing CAD identified; Education reassures patients with noncardiac chest pain; Skin helps predict heart disease. Read More
