Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
CSPC Pharmaceutical Group Ltd.’s SYS-6026 has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials for the treatment of high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV) type 16 or 18.
Antelope Surgical Solutions Inc. has received commercial IND approval from the FDA for its novel prostate cancer technology, AS-1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, will be evaluated in trials with the aim of addressing prostate cancer identification and surgical margin delineation.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
Abstract ideas are not generally eligible for patents in the U.S., but a recent dispute heard by the U.S. Patent Trial and Appeal Board adds a new twist to the question.
Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
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