Canadian healthcare regulators approved InSightec‘s ExAblate ultrasound system, clearing the device for use against 2 different diseases. Health Canada granted ExAblate indication to break up benign uterine tumors and to alleviate painful symptoms of metastatic bone tumors.
Baxter appeases EU regulators in $4B Gambro buyout
New NIH study examines brain implant for treating deafness in children
The National Institutes of Health is bankrolling the clinical evaluation of a brainstem implant that promises to restore hearing in deaf children.
Children’s Hospital Los Angeles and the House Research Institute will coordinate the 5-year trial for auditory brainstem implant (ABI) treatment. ABI was developed at House Research Institute in the 1970s, and the device has already successfully correct deafness in adults.
Diabetes: Novo Nordisk nabs 510(k) for kid-friendly insulin injection pen
Novo Nordisk landed FDA 510(k) for its NovoPen Echo, which the company touts as the 1st insulin pen to combine half-unit dosing with a memory log to help patients keep track of injection dose and time.
The Plainsboro, N.J.-based medical device maker said its new pen will be on the shelves in 2014. The FDA clearance follows green-lights from regulators in Canada, Europe and Israel.
Analysts: Device companies already absorbed excise tax | MassDevice.com On Call
MASSDEVICE.COM ON CALL — Many medical device companies have long petitioned for a repeal of the 2.3% excise tax on U.S. sales, but analysts say medtech companies have already managed to absorb the tax without taking a hit to the bottom line or jacking up costs for consumers.
Seven months into the tax, companies are instead coping by making layoffs, freezing salaries and restructuring. Many large medical device companies have landed headlines with exhaustive restructuring plans and sweeping layoffs.
Healthcare software and apps maker InVivoLink raises $1.9M
InVivoLink drummed up $1.9 million from 3 investors in a recent equity financing round, according to documents filed with the SEC. The recent $1.9 million is the 2nd wave of an initial funding promise from investors, set to kick in after InVivoLink achieved certain milestones, according to CEO Ryan Wells.
TAVI: Edwards’ Sapien XT heart valve wins reimbursement in Japan
A month after regulatory approval of the Sapien XT heart valve in Japan, Edwards Lifesciences (NYSE:EW) said it won reimbursement for the transcatheter aortic valve implant from Japan’s Central Social Insurance Medical Council.
Dentsply lands $13.5M DoD contract for surgical products
The U.S. Defense Dept. awarded a $13.5 million contract extension to the York, Pa.-based Dentsply International (NSDQ:XRAY) for surgical and other medical products.
Boston Scientific lands FDA wins for cardiac ablation devices
Boston Scientific touted a pair of FDA wins for cardiac ablation devices today, announcing pre-market approval for its IntellaTip MiFi XP high-resolution catheter and 510(k) clearance for the Zurpaz steerable sheath.
The IntellaTip is designed to help pinpoint cardiac ablation sites for surgeons, using high-resolution data to more accurately locate ablation points.
Boston Scientific wraps up patient enrollment for Innova bare metal stent trial
Medical device giant Boston Scientific’s (NYSE:BSX) enrolled the last of 299 patients in its SuperNOVA trial, moving the company 1 step closer to completing the clinical evaluation of its Innova bare metal stent.
JenaValve treats 1st non-European patients with transaortic TAVI
A pair of Canadian women, aged 87 and 71, became the 1st non-European patients to receive treatment with JenaValve Technology‘s new transcatheter aortic valve implantation system.
JenaValve’s 2nd-generation transapical TAVI device is surgically implanted in the natural aortic valve cavity, and features an anchoring and clipping mechanism to ensure the device stays in place.