GI Dynamics raises $2m

From Medical Design & Outsourcing

• What should really trigger a CAPA?
  When should a problem with a medical device trigger a CAPA (Corrective Action and Preventative Action)? Jon Speer at Greenlight Guru has some thoughts.  Jon Speer, Greenlight Guru After years of working with medical device companies, we’ve found that there is a particular area that is often rife with issues for companies: CAPA (Corrective Action and Preventative Action). […]
• 3M submits 510(k) for steam sterilization system
  3M has submitted an application for FDA 510(k) clearance for its Attest Super Rapid System for Steam Sterilization. The steam sterilization system can provide biological indicator results in 24 minutes. A faster readout time for steam will help improve patient safety while increasing workflow for sterilization professionals. “The focus of our sterilization science at 3M […]
• Guill Tool opens in-house rheology lab
  Guill Tool has launched its in-house rheology laboratory to minimize the time between testing and production. The company built its rheology lab in its West Warwick, R.I. facility. The lab has several machines that help produce optimum results when testing new materials that need to be extruded. The equipment is a hybrid rotational rheometer, a […]
• NSF International appoints new executive director of medical device certification and training
  NSF International has appointed FDA veteran Robert Ruff to the role of executive director of medical device certification and training. Ruff will offer expert training and certification services to NSF International’s medical device industry clients. He will be responsible for managing key sectors of the company’s medical device business. “Rob brings the utmost integrity and […]
• Qosina expands stopcocks line
  Qosina recently announced that it has added 12 new stopcocks to its line of bulk and non-sterile components. The new stopcocks are designed to be REACH and RoHS compliant with low profiles and low pressure ratings. They also feature unique configurations like build-in styles. Qosina offers 100 options of the stopcocks and supplies one-way, two-way, […]
• These medtech companies raised the most VC last year
  Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]
• Medtech stories we missed this week: Jan. 19, 2018
  From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news […]
• How blockchains could empower patients and secure data
  Blockchains are best known as the technology behind cryptocurrencies such as Bitcoin. But the founders of a young Atlanta-based company called Patientory think they could have another important use – securing health data and empowering patients along the way. Secure access to patient data is a major issue for the healthcare industry. Patients have a […]
• Phillips-Medisize’s increased business to benefit Molex plant in Arkansas
  Phillips-Medisize today announced a doubling of production for an undisclosed fast-growing medical customer with a take-home diagnostic kit for cancer detection – with benefits for the plant that Phillips-Medisize’s parent Molex runs in Little Rock, Ark. Phillips-Medisize, which is based in Hudson, Wis., did not disclose the identity of the customer, which it described as a leader […]
• GlobTek touts EAC-certified off-the-shelf power supplies for medical, other applications
  GlobTek is touting the wide variety of EAC-certified power supplies that it is offering for applications including medical, information technology equipment, household and more. A full list is available on the Northvale, N.J.–based company’s website.  EAC certification, formerly known as the Russian GOST-R certification, implements a new logo (EAC mark)  – and involves the implementation […]
• Robotic spine surgery is getting a real-time image guide boost
  For the first time, surgeons at Johns Hopkins Hospital were able to harness real-time image guidance during a robotic spine surgery procedure to insert screws into a patient’s spine. The process offers a marked improvement over the accuracy of placement compared with other image-guided procedures. Dr. Nicholas Theodore – professor of neurosurgery at the Johns Hopkins University […]