Stryker readies $110m Michigan facility

From Medical Design & Outsourcing

• NIH uses new imaging to see neural tissues in the retina
  The National Institutes of Health’s National Eye Institute is combining two imaging techniques to see live neurons, epithelial cells and blood vessels deep in the light-sensing retina of the eye. The two imaging techniques, called adaptive optics and angiography, could help the NEI change how eye diseases are detected and how conditions like age-related macular… […]
• Report: Med device recalls down in Q3
  Medical device recalls fell by 21% to 284 in the third quarter of 2018, according to a report by Stericycle Expert Solutions. Machine failure was the top cause of recalls based on units, while software led the way based on numbers of recalls, the report says. The total number of medtech recalls for Q3 was… […]
• Pre-clinical medical device testing under ISO 10993-1 and the MDR
  In today’s changing regulatory landscape, it’s more important than ever for medical device manufacturers to understand the nuances of pre-clinical device testing. Here are the implications of recent and pending regulatory updates, why extractables and leachables testing is more important than ever before, and how you can begin assembling the right team of testing experts… […]
• FDA clears Steribite’s kerrison rongeur
  Steribite (Cleveland) recently received FDA clearance for its disposable kerrison rongeurs. The kerrison rongeurs are used to remove bone on all spine procedures. Reusable ones are typically harder to clean, increasing the risk of infection to patients. The instruments are also expensive and hard to maintain and keep sharp, which poses a challenge to spinal… […]
• MTD Micro Molding invests in micro innovations
  MTD Micro Molding (Charlton, Mass.) recently announced that it has made significant investment in micro innovations this year. The company has invested 10% of its annual revenue into innovation. The investments go toward funding internal R&D projects that look at new micro molding capabilities. MTD Micro Molding has also hired Patrick Haney as its first… […]
• Defending the medtech industry: Q&A with Lori Cohen
  Nationally recognized for her trial record of 57 defense verdicts, Greenberg Traurig’s Lori Cohen is a leader in life sciences and product liability law – with nearly 25 years in the field. As an advocate for the medtech industry and for the advancement of women in life sciences, Lori Cohen is often tapped to represent industry members in their legal issues. Cohen is… […]
• How a teenage Gary Guthart, Intuitive Surgical’s CEO, got his start at NASA
  Today Gary Guthart is best know as the CEO of Intuitive Surgical (NSDQ:ISRG), the world’s leading medical robotics company. But robot-assisted surgery wasn’t Guthart’s first love, he told MassDevice.com ahead of his keynote appearance at this year’s DeviceTalks West event. That honor goes to NASA (or, more properly, science). During his teenage years growing up in […]
• FDA clears Spinal Elements’ surface coating technology
  Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device. Interbody fusion products with Ti-Bond technology… […]
• AliveCor app matches ECG in signaling certain heart attacks
  An international study has found that AliveCor’s smartphone app has nearly the same accuracy as a standard 12-lead ECG in monitoring heart activity and determining if someone is having an ST-segment elevation myocardial infarction (STEMI). The study led by researchers from the Intermountain Medical Center Heart Institute in Salt Lake City followed 204 patients with chest… […]
• Bio2 launches study of bioactive glass spinal implant
  Orthopedics company Bio2 Technologies has received FDA approval to begin enrollment in an IDE clinical study to evaluate its Vitrium bioactive glass as a cervical interbody fusion device. Vitrium will be evaluated as a structural device that facilitates bone remodeling via a gradual conversion from Vitrium to the patient’s own bone. A proprietary process is… […]
• This sterilization innovation is enabling in-situ curable silicone
  A novel method to develop in-situ curable silicone relies on gas-permeable packaging and EtO sterilization. A silicone dispensing system takes a new approach to sterilization in order to achieve in-situ curable silicone. This dispensing system allows silicone to be sterilized in the uncured form, opening new possibilities for silicone-based medical devices. “Silicones are widely used… […]