Combining research on emerging technologies with an accelerator program and a dedicated equity fund, the European Commission (EC) launched the European Innovation Council March 18 to invest in promising research and to scale up innovative startups and small- and medium-size businesses.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4Web, Maitri.
A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icad, Imbio, Inspire Medical Systems, Medtronic.
A new multilateral working group could bring deeper scrutiny to biopharma mergers, both past and future. The group, made up of competition experts from Canada, the EU, U.K. and U.S., is taking on the job of identifying fresh approaches to analyze and address the competitive concerns raised by biopharma M&As.
The U.S. Centers for Medicare & Medicaid Services (CMS) has imposed a 60-day delay in the implementation of the Medicare Coverage of Innovative Technologies (MCIT) program, stating that the MCIT draft rule was developed under a flawed assumption about the volume of eligible breakthrough devices. CMS said the situation suggests that the public did not have an appropriate opportunity to comment on the proposed rule, a predicament that suggests the possibility that the MCIT program might not survive the Biden administration’s regulatory review.
LONDON – Following circulating tumor cells and cell-free tumor DNA, a new type of liquid biopsy is poised for commercial rollout after Datar Cancer Genetics Ltd. secured CE marking for Trublood, a method for isolating tumor cell clusters. In fact, the clusters do not consist solely of tumor cells, but can also include endothelial cells, erythrocytes, stromal cells, leukocytes, platelets, and cancer-associated fibroblasts. They are held together by cell-to cell-adhesion proteins.
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.