Keeping you up to date on recent developments in oncology, including: Study clarifies distinct genomic features of early-onset appendiceal cancer; MET no better than EMT for cancer metastases; MRI may offer risk-stratification for glioblastoma; Study supports short telomeres as protective against cancer.
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.
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.
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.
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.
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).
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avelas Biosciences, Foldax.