FDA wants more from Proteus, Otsuka on ‘smart pill’

From Medical Design & Outsourcing

• Carbon lowers resin prices
  Carbon is lowering it resin prices to expand its bulk discount program that was introduced in 2017. Resins EPX 82 (epoxy), EPU 41 (elastomeric polyurethane) and RPU 70 (rigid polyurethane) are now offered in bulk volumes at $50 per liter. The company suggests that it will increase the total addressable market for parts that are… […]
• FDA clears Terumo’s CDI blood oxygen monitor
  Terumo has received FDA 510(k) clearance for its CDI Blood Parameter Monitoring System 550, which adds real-time oxygen delivery monitoring to its 12 critical blood parameters. Oxygen delivery measurements show how much oxygen is being delivered to a patient during a cardiopulmonary bypass. The company suggests that monitoring oxygen delivery has shown to reduce acute… […]
• This smart device drains the eyes of glaucoma patients
  Researchers from Purdue University have developed a smart drainage device that can help glaucoma patients. Glaucoma is a condition that damages the eye’s optic nerve and can cause vision loss and blindness. The Centers for Disease Control and Prevention estimates that about 3 million Americans are living with glaucoma. If there is early intervention, vision… […]
• Cadence helps set up manufacturing training site
  High-precision components and finished devices maker Cadence recently helped Valley Career and Technical Center (VCTC) in Fishersville, Va. to get its new computer-integrated manufacturing (CIM) program up and running to help train the new manufacturing workforce. Cadence (Staunton, Va.) funded a UR5 collaborative robot to be used in the lab’s robotics and automation work cell,… […]
• Exostar appoints new VP of product management
  Exostar announced that it has appointed Stuart Itkin as the company’s VP of product management. He will be responsible for all of the company’s strategic and tactical product management and product marketing activities. “I’ve admired Exostar for quite some time; the company plays a unique role in securing the A&D supply chain and enabling organizations… […]
• Dartmouth-Hitchcock hospitals to deploy Philips’ tele-ICU program
  Dartmouth-Hitchcock Health (Lebanon, N.H.) has agreed to implement Royal Philips’ (NYSE: PHG) eICU program technology.  The program aims to help reduce mortality, length of stay, and ventilation days while providing care to patients wherever they are located. Philips’ eICU is a tele-ICU program that will link specialists at the health system’s flagship hospital, Dartmouth-Hitchcock Medical… […]
• Qosina adds four new board members
  Qosina and its Qosmedix division have appointed four new board members. Pat Alesia, Robert Beckman, Ari Hoffman and Bruce Williams have joined members of the existing board Stuart Herskovitz, Janis Herskovitz and Scott Herskovitz. “We are delighted to welcome these talented leaders to our board of directors. Their combined industry expertise, operation leadership and proven… […]
• Cerus Endovascular starts European trial of intracranial aneurysm device
  Cerus Endovascular said it has enrolled the first patients in a study designed to assess the safety of the company’s Contour neurovascular system, which is designed to reduce the risk of rupture when treating patients with intracranial aneurysms. Intracranial aneurysms occur at the rate of nine per 100,000 with a wide range; in some countries, the rate is… […]
• 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… […]