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Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath

August 2, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Catheters, Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Alcyone Lifesciences

Penumbra touts stent retriever study data

July 28, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Clinical Trials, Stents, Vascular Tagged With: Penumbra Inc.

Smith & Nephew touts 1st-use of Navio robotic-assisted knee system

July 28, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Business/Financial News, Robotics Tagged With: Blue Belt Technologies, Smith & Nephew

EchoPixel launches clinical VR program

July 25, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Business/Financial News, Software / IT, Surgical Tagged With: EchoPixel, Hewlett-Packard Co.

Bigfoot Biomedical launches artificial pancreas trial

July 25, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Clinical Trials, Diabetes Tagged With: Bigfoot Biomedical

Halyard Health, Belintra ink sterile packaging & logistics pact

July 21, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Business/Financial News, Sterilization / Calibration Tagged With: Avanos Medical (formerly Halyard Health), Belintra

InfoBionic, BioTelemetry each claim win in patent spat

July 21, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Cardiovascular, Legal News Tagged With: BioTelemetry Inc., InfoBionic

Frenova discloses F1RST Up clinical trial accelerator participants

June 15, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Business/Financial News, Clinical Trials Tagged With: Frenova Renal Research, Fresenius

Silk Road touts TCAR study data

June 15, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Catheters, Clinical Trials, Stents, Vascular Tagged With: Silk Road Medical Inc.

Study: Insurance restrictions on lumbar fusions push procedure volumes down

June 9, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Spine, Surgical, Wall Street Beat

IBM Watson Health to aid in matching cancer patients to clinical trials

June 8, 2016 By Mark Hollmer Leave a Comment

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 […]

Filed Under: Big Data, Clinical Trials, Oncology Tagged With: IBM

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