Baxter (NYSE:BAX) alerted Canadian peritoneal dialysis patients about potential overfill issues with its HomeChoice machines and tipped Hong Kong regulators about the risks of altering the HomeChoice device’s power cord to fit local outlets.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
CryoLife lands FDA win for next-gen HeRO device
The FDA granted 510(k) clearance for CryoLife‘s next-generation HeRO system in treatment of patients undergoing hemodialysis, the company announced.
The new HeRO device includes an adaptor so that it can connect CryoLife’s proprietary venous outflow to other dialysis grafts, including early access grafts, the company reported.
Aptus Endosystems CE Mark for next-generation for Heli-FX
Aptus Endosystems won CE Mark approval in the European Union for its next-generation thoracic-length delivery system for the Heli-FX device aortic securement device.
The newly green-lighted system includes a longer delivery device and additional features to treat thoracic aortic aneurysms. According to company estimates, this patient population in Europe includes 5,000 newly diagnosed patients and 12,000 patient treated overall each year.
Bausch + Lomb laser device wins new approvals in Europe
Bausch + Lomb won new CE Mark approvals for its Victus laser platform, allowing the device maker to market the system for additional uses during cataract surgery.
In additional to corneal incision, European regulators approved 2 additional indications for Victus, green-lighting the system for use during full corneal transplant, or penetrating keratoplasty, and for incisions performed during device implants into the eye.
Diabetes: Abbott recalls FreeStyle Insulinx glucose monitor on software glitch
Abbott (NYSE:ABT) recalled its FreeStyle Insulinx blood glucose meter after discovering a software glitch that could deliver incorrect results.
The Chicago-area medical device company said that the FreeStyle Insulinx might display incorrect test results at blood glucose levels of 1024 mg and above. Abbott said there’s been a single reported "patient incident" involving the glitch, according to a press release.
FDA advisors look to Hurricane Katrina, Japanese tsunami for lessons in protecting medtech systems
An FDA panel on April 11 advised the federal watchdog agency to take another look at its emergency risk mitigation strategies, particularly in regard to how events like extreme weather and natural or nuclear disasters may threaten medical devices.
U.S. FDA guidance explains user fees for medical device reviews
By Stewart Eisenhart, Emergo Group
FDA approves Boston Scientific’s Precision Spectra pain relief device
Boston Scientific (NYSE:BSX) said it’s beginning a limited U.S. launch of its Precision Spectra spinal cord stimulation device now that the FDA has approved it for treating chronic pain.
The Natick, Mass.-based medical device company said the device is designed to deliver controlled electrical pulses that mask pain signals on their way to the brain.
Smiths Medical’s recall gets FDA’s highest-risk label | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA put its highest-risk stamp on Smiths Medical’s alarm cable recall, warning that a rare issue may cause patients harm or even death.
The BCI remote alarm cables are meant for use with Smiths Medical’s 9004 Capnocheck Capnography systems, transferring alarms from the system to a remote alarm system.
Elekta lands FDA win for next-generation linear accelerator
Maquet lands FDA nod for Air-Band catheter device
Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular racked up a win for another of its devices designed to close artery incisions for catheters after the FDA cleared its Air-Band radial compression device for the U.S. market.
The device is designed to help seal the radial artery after a catheterization procedure, in which the catheter is threaded into the heart via a radial artery incision in the wrist.