Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s Hospital. The Lowell, Mass.-based company said that its decision to file a 510(k) premarket notification with the FDA seeking a regulatory sign-off for its ReFlow […]
Penumbra touts stent retriever study data
Penumbra (NYSE:PEN) said a 198-patient trial of its next-generation stroke-treatment device along with another company product showed promise, meeting primary endpoints. Results were positive enough that a 2016 regulatory submission remains part of the plan. “The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to […]
Smith & Nephew touts 1st-use of Navio robotic-assisted knee system
A New York hospital is the 1st to use Smith & Nephew (NYSE:SNN) new robotics-assisted total knee replacement procedure following its recent 510(k) clearance from the FDA. The surgery took place at the John T. Mather Memorial Hospital in Port Jefferson, N.Y., involving Smith & Nephew’s handheld robotics-assisted Navio platform, and its Journey II BCS knee […]
EchoPixel launches clinical VR program
EchoPixel said it will start making its signature 3D medical imaging software available to physicians and surgeons through a partnership with HP. Specifically, the Mountain View, Calif.-based company said it will pair its True 3D system with HP’s Zvr Interactive Virtual Reality Display and workstation. True 3D lets physicians interact with CT or MR images […]
Bigfoot Biomedical launches artificial pancreas trial
Bigfoot Biomedical is launching a clinical trial of its Smartloop automated insulin delivery system at medical centers in California and Colorado. The Milpitas, Calif.-based company said it has enrolled its 1st patients in a trial of its Smartloop device that will be conducted at three sites: Stanford University School of Medicine (working with Lucile Packard Children’s […]
Halyard Health, Belintra ink sterile packaging & logistics pact
Medical technology company Halyard Health (NYSE:HYH) and Belintra, a healthcare logistics provider, will pursue a co-marketing partnership focused on improving the sterility of wrap products before they head into an operating room. The deal involves Georgia-based Haylard’s sterilization wrap products and Belintra’s storage and transport logistics flow system for wrapped surgical instrument trays. Belintra’s Sterisystem Logistics […]
InfoBionic, BioTelemetry each claim win in patent spat
Both BioTelemetry (NSDQ:BEAT) and digital health startup InfoBionic celebrated victory in their patent fight with each other over wireless cardiac monitoring technology. But the battle is far from over. Pennsylvania-based BioTelemetry disclosed that the Massachusetts District Court stopped InfoBionic from making, using, marketing or selling in the U.S., or importing into the country, any of its […]
Frenova discloses F1RST Up clinical trial accelerator participants
Four months after it launched a clinical trial accelerator, Fresenius‘s (NYSE:FMS) renal research arm Frenova disclosed the initial participants. Fourteen research centers around the U.S. will take part in the F1RST Up accelerator (Frenova Rapid Start Up). Frenova general manager said in prepared remarks that the participants include “some of the most productive clinical research […]
Silk Road touts TCAR study data
Silk Road Medical disclosed encouraging new clinical data for its Enroute device, which is cleared to help protect the brain from stroke while implanting a transcarotid artery stent. The company said that additional data showed its Enroute transcarotid neuroprotection and stent system, indicated for transcarotid artery revascularization (TCAR), helped improve stroke and death rates in […]
Study: Insurance restrictions on lumbar fusions push procedure volumes down
An insurance policy limit on lumbar fusion procedures helped slash costs and medically unnecessary surgeries in North Carolina, and the approach could work nationally, according to new research published in the journal Spine. “The commercial insurance policy change had its intended effect of reducing fusion operations for indications with less evidence of effectiveness, without changing […]
IBM Watson Health to aid in matching cancer patients to clinical trials
IBM‘s (NYSE:IBM) famed Watson artificial intelligence platform will be put to use to help match cancer patients with clinical trials. The Armonk, N.Y.-based technology giant said Froedtert & the Medical College of Wisconsin Network will adopt the Watson technology for this purpose in a project set to begin this fall. Froedtert/MCW Cancer Network are among the 1st cancer […]
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