The negotiations for the next medical device user fee agreement are well underway, but the FDA is pressing the case for a substantial increase in device user fees. While the controversy over the cost of each addition to the FDA staff has not gone away, the agency continues to compare device user fees to drug user fees even though the drug industry is populated by much larger companies, thus nullifying any such comparisons in the view of device makers.
Zimmer Biomet Holdings Inc. has won the FDA’s nod for its Rosa Partial Knee system for robotically assisted partial knee arthroscopy. The new system is the latest addition to the Rosa Robotics platform, which also includes the Rosa Knee system for total knee replacement and Rosa One for neurosurgical and spine procedures. The Rosa Partial Knee system is designed to be compatible with Zimmer’s Personal partial knee. It incorporates 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on both soft tissue and bone anatomies to ensure accurate bone cuts and improve range of motion gap analysis.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA provides path for diagnostic testing using pooled samples; FDA inks warnings for pandemic testing; Recall issued for repaired infusion pumps; NICE launches transformative strategy; NICE launches transformative strategy; Russia expands access to certain pediatric treatments.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livanova, Spinal Elements, Zimmer Biomet.
Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD Alaris pumps recalled over keypad problems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agnovos Healthcare, Canon Medical, Contego Medical, Deephealth.
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
The FDA has finalized a 2018 draft rule that excludes several digital products from the definition of a medical device, a list that includes medical device data systems (MDDS) used in hospitals. The rule responds to requirements spelled out in the 21st Century Cures Act, which was signed into law in late 2016, making this a project of nearly five years’ duration on the FDA’s part.
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