Stereotaxis Inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, marking a key step in the company’s effort to evolve 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. Read More
It appears that Staar Surgical Co.'s proposed $1.6 billion merger with Alcon AG has been scrapped as Staar shareholders voted against the deal in a stockholder meeting on Jan. 6. 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 stand-alone, publicly traded company. Read More
Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain. Read More
Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction. Read More
China’s National Medical Products Administration (NMPA) 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. Read More
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 upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively. Read More
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cumulus Neuroscience, Freenome Holdings, Hyperfine, Linus Health, Ventric Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gore, Spectrumedics, Stereotaxis. Read More
