In the last week, the U.S. FDA has taken two steps to expand treatment options for the millions of patients with fibromyalgia who find little relief from the three approved drugs for the condition. Neurometrix Inc. reported that the agency granted de novo authorization to its Quell device Thursday and Remedee Labs SA announced it received breakthrough device designation for its endorphin stimulation system May 12. Read More
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October. Read More
Device makers do not engage in direct-to-consumer advertisement at the same pace as drug makers, but advertising and promotions are still a minefield of potential enforcement action for the unwary manufacturer. According to Jesse Atkins and Nate Downing of Gardner Law in Stillwater, Minn., even a minor skirmish with the FDA can result in an extensive review of standard operating procedures, a potentially expensive and time-consuming distraction from companies fighting for market share in the hotly contested U.S. market. Read More
Abbott Laboratories Inc. presented one-year outcomes from its PORTICO NG study assessing the latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor in patients with severe aortic stenosis. The valve, which includes a new active sealing cuff, builds on the company’s Portico transcatheter heart valve platform. Read More
Abbott Laboratories Inc. reported 30-day results from its Triclip Bright Study at the EuroPCR meeting in Paris on May 19. The real-world outcomes showed that the company’s tricuspid repair systems Triclip and Triclip G4 transcatheter edge-to-edge repair (TEER) significantly reduced tricuspid regurgitation (TR) and substantially improved the quality of life across a wide range of anatomically diverse patients. Read More
The Biden administration recently reported that a new round of free rapid tests for the SARS-CoV-2 virus is available to the public, a development that coincides with a new surge of the latest sub-variant of the omicron variant. However, the administration is also expected to renew the public health emergency (PHE) for the pandemic, even as the White House continues to press Congress for another $22 billion in pandemic-related funding. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Medtronic, Shockwave Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2B3D, Biocorrx, Brainlab, Dante Labs, Genetic Analysis, Lumendi, Mainz Biomed, Omnigene Medical, Prenetics, Rune Labs. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Neuromatrix. Read More
