Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
In another real-life episode of “sponsor beware,” the owners of a clinical research facility pleaded guilty March 10 in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs.
Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the non-invasive Sooma 2Gen device in improving MDD as an at-home treatment.
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
Professor Alexander Star and researchers from the University of Pittsburgh have filed for protection of their development of a rapid, affordable, and reliable tuberculosis diagnostic tool.
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
With millions of people suffering from chronic back pain, Discure Technologies Ltd. is hoping that its bioelectronic therapy, the Discure system, will soon bring relief.
With more than three weeks left in the first quarter, the value of med-tech IPOs for 2025 already exceeds the funds raised from all IPOs for med-tech companies in the last two years combined. Kestra Medical Technologies Ltd. provides a clear example of how fast the market is heating up, with a final IPO that raked in more than twice as much as initially expected, while Advanced Biomed Inc. shows the appeal of the U.S. exchanges for non-U.S. companies.
Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.
4C Medical Technologies Inc. raised $175 million in a series D financing round led by Boston Scientific Corp. The financing will support the regulatory trials and commercialization of the Altavalve system, a transcatheter mitral valve replacement (TMVR) technology.