With FDA approval in hand, St. Jude Medical (NYSE:STJ) launched a new and improved ablation catheter that features a GPS-like body navigation system called MediGuide.
Insurance company Affinity Health pays $1.2M for a photocopier fumble
New York-based insurance company Affinity Health Plan agreed to shell out $1.2 million to quell a lawsuit over an alleged technical fumble that exposed private patient information.
Cardica files for FDA clearance for MicroCutter device
Ortho Kinematics’ back diagnostic device lands expanded clearance
With a new 510(k) clearance from the FDA in hand, Ortho Kinematics can offer its Vertebral Motion Analysis spine diagnostic test to patients with neck problems.
Diabetes: FDA slaps Nova’s glucose test strip recall with a Class I label
After Nova Biomedical issued a voluntary recall letter for its Nova Max test strips and glucose meter kits, the FDA determined that the measure qualified as a Class I recall, a label reserved for issues that pose a threat of significant patient harm.
Natus launches electro-diagnostic system in the U.S., Canada
Natus Medical (NSDQ:BABY) landed regulatory wins from the FDA and Health Canada for its UltraPro S100 EMG, a new electro-diagnostic system designed to monitor a patient’s nervous and muscular systems.
Diabetes: Do smartphones fit the bill for the next mobile artificial pancreas? | MassDevice.com On Call
MASSDEVICE ON CALL — Smartphones are capable of meeting all the criteria for an artificial pancreas by providing close-loop, outpatient control of glucose levels for diabetics, according to a new study published by the American Diabetes Assn.
Mitral valve surgery: The sooner the better, study says
Patients with severe mitral regurgitation showed significantly better survival rates after early surgery, compared with a "watchful waiting" approach, according to a study published this week in the Journal of the American Medical Assn.
CircuLite warns on Synergy heart pumps after receiving cannula fracture reports
Regulators in the UK and Hong Kong issued warnings on CircuLite’s Synergy circulatory support system after at least 3 reports that the devices’ inflow cannulae fractured.
Recall: FDA sounds the alarm on Hospira blood kits after 1 patient dies
1st-of-its-kind Phase I trial will treat MS patients with their own stem cells
The FDA gave New York’s Tisch MS Research Center a green-light to move forward with a 1st-of-its-kind Phase I investigational new drug trial that will aim to treat multiple sclerosis with a direct spine injection of the patient’s own stem cells.