The C-suite at Dexcom Inc. is breathing easy with the company having snagged CE marking for its latest continuous glucose monitoring (CGM) system, the G7, less than two weeks after receiving FDA breakthrough device designation for its CGM for hospital use. “This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better,” said Dexcom CEO Kevin Sayer. Read More
Norwegian diagnostics company Cardinor AS landed a CE mark for its Secretoneurin (SN) ELISA (enzyme-linked immunosorbent assay). The blood-based test detects SN, a small 33-amino acid neuropeptide produced by neuroendocrine and heart muscle cells. Studies have shown the biomarker is a predictor of mortality in major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with cardiovascular disease (CVD) and severe sepsis. Read More
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world. Read More
Interrad Medical Inc. has formed a strategic partnership with Eloquest Healthcare Inc. to accelerate sales growth of what is described as the only subcutaneous catheter securement device in the world. Read More
The FDA issued a rare 518(a) Notification Order to Royal Philips NV last week that requires the company to take more aggressive measures to notify patients, physicians and distributors about the June 2021 class I recall of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) systems. The recall stemmed from health risks posed by the deterioration of the polyester-based polyurethane (PE-PUR) noise reducing foam in the equipment. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apyx Medical, Glaukos, Glucotrack, Happify, Medtech Acquisition, Memic, Neuro-Sysmed, Otivio, Realm Idx, Safe Group, Sophia Genetics, Zuellig. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Fresenius Kabi, Guardant Health, Myriad Genetics, Shoulder Innovations. Read More
