The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE unimpressed by stenosis measurement software; MedPAC says more study needed for expanded telehealth coverage.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA sets up webpage, template for screening; Stryker’s STAR ankle exhibiting fracture risk.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA comments on two patent term extensions; Comment period reopened on Orange Book patents.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of infusion sets; Recall announced for Roche testing systems; NIH announces technique for improved photoreceptor imaging.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Stimulus passes, no Medicare sequestration relief; OIG cites improper claims for polysomnography; Four senators seek feedback on Section 101 hangup.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Biontech, EMA, Health Canada, Minister of Health, Moderna, NIH, Pfizer, PhRMA, WHO.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.