FDA Clears Next-Gen Enroute TNS
Silk Road Medical has gained FDA clearance for its next-generation Enroute transcarotid neuroprotection system, indicated for transcarotid artery revascularization. The system allows for direct access to the carotid artery to target blockages that could cause a stroke. The first procedures with the device have been performed across the country.
IsoRay Cans GliaSite Due to Low Sales
IsoRay has bid adieu to its GliaSite radiation therapy system and certain ancillary products, following “marginal sales” since its introduction, the company announced in a regulatory filing. IsoRay has issued notices to end licensing agreements with Dr. Reddy’s Laboratories and Hologic and has slashed a distribution agreement with Karlheinz Goehl-Medizintechnik Goehl. The system is designed to deliver brachytherapy radiation to treat brain cancer.
FDA Clears FilmArray Torch for 3 More Panels
subsidiary BioFire Diagnostics has garnered FDA clearance for its FilmArray Torch for use in conjunction with the FilmArray blood culture identification panel, gastrointestinal panel, and meningitis/encephalitis panel. Additionally, the system received the CE Mark.
The PCR system offers up to “six times more sample throughput per square foot of benchtop space,” according to the company. The system was previously FDA cleared for use with the FilmArray respiratory panel in February.
Halyard Health to Acquire Corpak MedSystems
Halyard Health, a developer of infection prevention solutions, has entered an agreement to acquire Corpak MedSystems. Under the agreement, Halyard will pay $174 million in cash consisting of current cash and Halyard’s credit facility, according to a prepared statement. Completion of the transaction is expected during the second quarter and is subject to customary conditions.
RTI Surgical Adds Solution to Streamline TL System
RTI Surgical has unveiled its Streamline TL spinal fixation system with deformity instrumentation for use in adult deformities or curvatures. The system allows for the creation of a rigid construct within the thoracolumbar spine using pedicle screws, set screws, rods and crosslinks, according to the Alachua, Fla.-based company. The device first launched in 2011, and the company has continued to expand the system’s offerings over time.
Predictive Technology Group Acquires ReNovo
Predictive Technology Group has finalized its acquisition of ReNovo Biotech, which will now be called Predictive Biotech, the Salt Lake City, Utah-based company announced Tuesday. PRED will gain access to ReNovo’s cellular, tissue, biomaterial and regenerative products and candidates, in addiction to distribution channels. The buy advances PRED’s expansion strategy of acquiring complementary diagnostic and therapeutic companies. Financial terms were not disclosed.