The covey of medical device executives that alit on Capitol Hill last week to lobby for repealing the medtech tax and getting a new user fee deal with the FDA in place reportedly found a ready ally in Dr. Tom Price, head of the U.S. Health & Human Services Dept. More than 50 medical device […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Senate drug price hearing turns into debate over healthcare reform
Members of the Senate Health, Education, Labor and Pensions committee gathered last week to discuss the rising costs of prescription drugs. But the hearing quickly morphed into a heated back-and-forth between senators over the Republican’s efforts to reform healthcare. When you need to get quick access to money, no fee loans are one of the […]
Getinge’s Maquet, Datascope recall select IABPs over electrical issues
The FDA today released information on a select voluntary recall from Getinge‘s (PINK:GETI B) Datascope and Maquet of its System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures. Datascope said they received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a […]
FDA clears IND for Cerveau’s tau imaging agent
Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent. The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like […]
Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus
Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus. The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive […]
Adamis up, Mylan down on generic EpiPen approval
Shares in Adamis Pharmaceuticals (NSDQ:ADMP) soared more than 50% yesterday after it won FDA approval for its generic EpiPen emergency allergy pre-filled syringe, sending shares in competitor Mylan (NSDQ:MYL) down -3%. For years, Mylan has commanded more than 90% of the market for emergency epinephrine injectors. Get the full story at our sister site, Drug Delivery […]
Hologic’s Cynosure wins FDA expanded indications for SculpSure
Hologic (NSDQ:HOLX) said today its Cynosure subsidiary won expanded clearance from the FDA for its non-invasive SculpSure body contouring device. With the expanded indication, the SculpSure is now cleared for treatments of the back and inner and outer thighs, the Marlborough, Mass.-based company said. The device is already cleared for treatment of the abdomen and flanks. The […]
BD recalls select Plastipak catheter tip syringes over leakage issues
Becton Dickinson (NYSE: BDX) is initiating a voluntary product recall for its 100ml Plastipak catheter tip syringes over leakage issues the company discovered during testing. The Franklin Lakes, N.J. company discovered that the devices, which are labeled with a 5-year expiration date, were found to be failing during routine real-time stability tests, beginning at the 2-year […]
FDA warns on frameless stereotactic navigation systems
The FDA is warning of the risk that frameless stereotactic navigation systems, used to plan and conduct ear, nose & throat, brain and facial surgeries, might not be accurate if not used properly. Stereotactic navigation uses computed tomography or magnetic resonance imaging scans to generate a “map” surgeons use to guide their instruments. Some systems […]
FDA clears Siemens Healthineers Magnetom Vida 3T MRI scanner
Siemens (NYSE:SI) Healthineers said today it won FDA clearance for its Magnetom Vida 3 Tesla magnetic resonance imaging system. The company said that the newly cleared 3T MRI scanner features new BioMatrix technology designed to address inherent anatomical and physiological differences in patients and user variability to reduce rescans and increase productivity and cost efficiency. Siemens […]
Lilly wins FDA nod for Humalog pre-filled Junior KwikPen device
Eli Lilly (NYSE:LLY) said today that the FDA approved its Humalog Junior KwikPen for the treatment of diabetes. The device is a pre-filled pen with half-unit dosing capabilities, which Eli Lilly said gives patients access to finer dose adjustment. Get the full story at our sister site, Drug Delivery Business News.