Safeguard Medical LLC further consolidated its position in the first responder market with the acquisition of H&H Medical Corp. Williamsburg, Va.-based H&H produces military-grade trauma response products for field medics and emergency responders. "Our mission at Safeguard Medical is to equip and enable responders at every skill level to preserve life in any environment. The acquisition of H&H adds another trusted brand to our market-leading portfolio and expands our ability to partner with life-saving responders around the world," said Adam Johnson, Safeguard Medical’s CEO.
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.
The FDA lost another hearing in the lawsuit filed against the agency by Genus Medical Technologies LLC in a case that yet again resurrects the product classification question. Both courts that heard the lawsuit asserted that the FDA does not enjoy unfettered discretion to classify a device as a drug merely as part of its authority under the Administrative Procedures Act (APA).
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.
Persistent U.S. drugs supply chain vulnerabilities, troublesome even before the COVID-19 pandemic, are drawing new attention in Washington. Now, with growing calls to increase supply chain resilience and a Biden administration executive order calling for an assessment of the situation, experts are looking for new paths to limit the risk of drug shortages, protect patient health, and to address pandemic preparedness and other national and health security threats.
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.
DUBLIN – The Biden administration’s proposals on global corporation tax reform have set alarm bells ringing across the Irish government, as officials digest the possible implications of the plan for Ireland's foreign direct investment model of economic development.
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 Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health.
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