Augmenix said last week that a pivotal study of its SpaceOar system was published online in the International Journal of Radiation Oncology•Biology•Physics. The 222-patient pivotal study was designed to evaluate safety and efficacy of the SpaceOar System in men undergoing prostate radiotherapy, the company said. The SpaceOar is designed to separate the prostate from the rectal wall during radiation […]
Urology
Terumo looks to Olympus for GlideWire distribution
FDA OKs trial for StimGuard’s bladder implant
StimGuard said it won an investigational device exemption from the FDA for a clinical trial of its micro-size implantable device to treat overactive bladder syndrome. StimGuard said its system uses a small injectable microchip and an external transmitter and requires no invasive surgery to implant. The trial is slated to begin in summer 2015.
Boston Scientific prices $1.85B debt offering
Profound Medical goes public in reverse merger
Profound Medical yesterday said it’s slated to hit the public markets in Canada after a reverse merger, also revealing a $24 million private placement to fuel clinical trial work.
Augmenix wins FDA nod for SpaceOar prostate treatment
FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to help protect the rectum during prostate cancer radiotherapy, CEP John Pedersen told MassDevice.com today.
Uroplasty, Vision-Sciences merge as Cogentix
Uroplasty, Vision-Sciences shareholders OK merger
Bioness launches clinical trial for StimRouter in overactive bladder
Bioness last week said it’s making progress with a Canadian study of its StimRouter neuromodulation device designed to expand the number of conditions for which it can be used for treatment.