Researchers in Europe have developed mathematical models and numerical algorithms that break down medical images like Lego bricks to help guide surgeons during brain surgery. University of Luxembourg and University of Strasbourg researchers collaborated to create algorithms to predict the deformation of the brain during surgery and give information pertaining to the current position of […]
Surgical
ClearFlow wins FDA 510(k) for FlowGlide
ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains. The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions. “ClearFlow is […]
Swiss Kuros Biosciences wins CE Mark for NeuroSeal dural sealant
Swiss tissue repair and regenerative med focused Kuros Biosciences said today it won CE Mark approval in the European for its Neuroseal novel dural sealant. The Neuroseal sealant is designed as an adjunct to suturing and is used to seal the dura after cranial surgery and reduce the risk of cerebrospinal fluid leakage, the company […]
BD wins FDA nod for customizable mini-laparoscopic instruments
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its line of Snowden-Pencer 3mm laparoscopic customizable surgical instruments. The line of Snowden-Pencer instruments are designed for micro-laparoscopic surgery and are intended to function like 5mm instruments, the Franklin Lakes, N.J.-based company said. Jaw lengths on the devices are designed to mirror […]
Stryker to pay $700m for Novadaq
Novadaq Technologies (TSE:NVDQ) said today that it agreed to a $700 million offer from Stryker (NYSE:SYK) for its line of fluorescence imaging technology. Mississauga, Ontario-based Novadaq said the $11.75-per-share offer is a 95.8% premium on its $6 closing price June 16, for a valuation of roughly $701 million; Stryker said that includes some $47 million in […]
Study: 33% of heart surgery devices could be contaminated with deadly bacteria
More than 33% of heater cooler units examined between July 2015 and December 2016 tested positive for Myobacterium chimaera, a bacteria that has been known to cause fatal infections during open-heart surgeries, according to new research presented this week. The research was presented by Special Pathogens Lab VP of lab services John Rihs at the […]
DJO Global launches fresh fracture trial for bone growth stimulator
DJO Global said today that it plans to launch a clinical trial for a new indication of the company’s bone growth stimulator. The company’s subsidiary, Encore Medical, is seeking an investigational device exemption trial evaluating a fresh fracture indication for its combined magnetic field device. FDA-approved CMF devices are traditionally used with non-magnetic internal or external […]
Vertera touts CMS reimbursement nod for radiolucent spinal fusion device
Vertera Spine said today that the Centers for Medicare & Medicaid Services issued a new ICD-10 code for its radiolucent porous spinal fusion device. The company’s Cohere cervical interbody fusion device is the 1st and only clinically-available porous fusion device made out of Vertera Spine’s radiolucent PEEK biomaterial. It is also the only device approved […]
Invuity recalls PhotonBlade
Invuity (NSDQ:IVTY) said today that it recalled its PhotonBlade minimally invasive surgery light, after a few customers reported “unintended energy discharge” during procedures. The PhotonBlade device, which won 510(k) clearance from the FDA in August 2016, was in a limited market release that began in March, Invuity said. Customer feedback, gathered to inform improvements to the […]
MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause […]
Terumo, U Penn face heater-cooler infection lawsuit
Terumo Corp. (TYO:4543) and the University of Pennsylvania are facing a suit from a New Jersey woman who claims to have contracted a serious bacterial infection from a Terumo HX2 heater-cooler device during a heart surgery last year, according to a press release published yesterday. Counsel for the plaintiff, Marisa Karamonoogian, said that her and her husband […]