Stereotaxis inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, a key step in the company’s evolution from a niche robotics supplier into a more vertically integrated electrophysiology technology provider. The approval positions Magic as Stereotaxis’ first proprietary robotic ablation catheter in the U.S. and follows a series of regulatory and commercial milestones in recent months that reset the company’s growth narrative.
Alcon wishes on the wrong Staar as $1.6B merger rejected
It appears that Staar Surgical‘s proposed $1.6 billion merger with Alcon AG has been scrapped as Starr shareholders voted against the deal in a stockholder meeting today. In a statement Staar said it intends to terminate its merger agreement with Alcon. No termination fee will be payable by either party, and Staar will remain a standalone, publicly traded company. The decision to terminate the deal marks the end of a lengthy squabble between the Staar board and a sizable group of its shareholders that believe that the Alcon offer was insufficient.
Naox secures FDA clearance for EEG earbuds
Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds which the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.
New legislation would apply product liability principles to AI
Software as a service (SaaS) has typically been less susceptible to liability than products per se, but that may soon come to an end if a new bill in the U.S. Senate gains sufficient traction. The AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, would largely if not entirely strip away some of the liability protections afforded to products that function as SaaS, a change that could affect developers of AI in medical uses.
NMPA aims to tamp down on online sales of medical technology
China’s National Medical Products Administration has issued guidance governing online sales of medical devices with a focus on inspections of the products’ manufacturing facilities. The agency made it clear that the manufacturer will have to deal promptly with any deviations from the regulations or face enforcement action, signaling a new era of tighter scrutiny of online sales of these products.
Appeals court says no to cap on indirect costs in NIH grants
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit yesterday upheld a permanent injunction issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively. Affirming the district court’s jurisdiction in the matter – something the NIH had challenged, the appeals court said the agency’s supplemental guidance violates both a congressional appropriations rider and the Department of Health and Human Services’ own duly adopted regulations. Congress enacted the rider in the first Trump administration, and every year since, in response to President Donald Trump’s first efforts to cap indirect costs at 10%.