In Part 1 of this blog, I described the background and approaches StarFish Medical employed for more modern devices with a comprehensive technical file, giving five top tips. In Part 2, I now describe how we recertified for older devices where the available design documentation was less comprehensive.
Ocular Therapeutix, Inc. announced today that the U.S. Food and Drug Administration (FDA) has scheduled an Ophthalmic Devices Panel meeting on September 19, 2013 to discuss, make recommendations, and vote on the company’s Premarket Approval (PMA) Application for the ReSure Sealant.
Following the rigorous process required by the ISO community to validate quality management systems, EMCO High Voltage Corporation is now ISO 9001:2008 certified. EMCO High Voltage Corporation, a leading designer and manufacturer of high voltage power supplies, announced today that it has completed ISO 9001:2008 certifications.
Medicare officials released new hospital payment rules for 2014 that would increase certain budgets and take steps to implement healthcare reform measures mandated by the Affordable Care Act. CMS increased payment rates for inpatient stays at both general and long-term care hospitals and hones definitions for what types of situations merit hospital admission.
Symmetry Medical saw its 2nd-quarter profits plunge more than 28% on flat sales and lowered its outlook for the balance of the year. The Warsaw, Ind.-based medical device company posted profits of $1.2 million, or 3¢ per share, on sales of $101.9 million for the 3 months ended June 29, for a top-line slip of 0.4% and a bottom-line plunge of 28.1% compared with the 2nd quarter of 2012.
Healthcare giant Johnson and Johnson says it is pleased to put a legal dispute behind it after a Chinese court ordered it to pay compensation to a former distributor under an anti-monopoly law. Thursday's ruling said Johnson & Johnson was guilty of "vertical monopoly" for setting minimum prices its distributors charged for surgical sutures.
Some animals—like the octopus and cuttlefish—transform their shape based on environment, fending off attackers or threats in the wild. For decades, researchers have worked toward mimicking similar biological responses in non-living organisms, as it would have significant implications in the medical arena.
Engineers at the University of California, Berkeley, have built a device that could speed up medical imaging without breaking the bank. The key ingredient? An engine lubricant called molybdenum disulfide, or MoS2, which has been sold in auto parts shops for decades.
Dentsply International managed to boost its 2nd-quarter profits despite flat sales, saying headwinds in Europe will push down its earnings for the rest of the year. York, Pa.-based Dentsply posted profits of $87.2 million, or 60¢ per share, on sales of $761.0 million for the 3 months ended June 30. That represents bottom-line growth of 8.0% on a 0.3% sales decline.
Medical device giant Edwards Lifesciences is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.
In a study carried out at the University of Eastern Finland, bone histomorphometry and infrared spectroscopy revealed abnormal bone properties in children with vertebral fractures and in children after solid organ transplantation. Bone compositional changes in children with vertebral fractures and after different types of organ transplantation have not been reported previously.
ICU Medical is in exclusive talks with a Chicago-based private equity shop, GTCR LLC, about a leveraged buyout, unnamed sources told Bloomberg BusinessWeek. The private equity firm has raised up to $750 million to back the takeover, according to a person "familiar with the matter," the magazine reported.
Alere Connect has been granted a 510(k) market clearance by the U.S. FDA for the Alere MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.
Reaching a clinic in time to receive an early diagnosis for cancer -- when the disease is most treatable -- is a global problem. And now a team of Chinese researchers proposes a global solution: have a user-friendly diagnostic device travel to the patient, anywhere in the world.
A novel interactive 3Dimensional (3D) simulation platform offers surgical residents a unique opportunity to hone their diagnostic and patient management skills, and then have those skills accurately evaluated according to a new study appearing in the August issue of the Journal of the American College of Surgeons.