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From Medical Design & Outsourcing

• FDA guidance explains electronic records for medical device clinical trials
  By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
• West Pharmaceutical Services touts needle shield
  West Pharmaceutical Services has expanded its product offerings to include the Rigid Needle Shield (RNS). The RNS helps add safety to profiled syringes with a staked needle. It also helps ensure the integrity of injectable drug products. “Pharmaceutical companies continue to look for drug packaging and delivery solutions that offer safety, efficiency and an improved […]
• Advanced Sterilization Products receives 510(k) clearance for BI system
  Advanced Sterilization Products announced that it has received FDA clearance for its Sterrad Velocity Biological Indicator (BI) system. The system reduces the time it takes to get sterilization results from several hours to only 30 minutes. BIs traditionally help prevent hospital-born infections, which can be costly. “With a significantly shorter wait time, Sterrad Velocity reduces […]
• Acessa Health closes bankruptcy buyout of Halt Medical, raises $30m
  Acessa Health said today that it closed the bankruptcy buyout of Halt Medical and promptly raised a Series A round worth $30 million. The Acessa device is designed to treat uterine fibroids using radiofrequency ablation. Its successor namesake emerged after a Delaware federal bankruptcy judge earlier this month approved the bankruptcy sale, which was designed to keep the […]
• Renishaw brings its stereotactic robot to Canada
  The London Health Sciences Center in London, Ontario, has installedRenishaw’s Neuromate stereotactic robot, the first instance of the robot in Canada. The procedure was a stereoelectroencephalography (SEEG), which uses an intracerebral electrode to measure electrical signals in the brain. The goal of the procedure is to figure out which part of the brain generate the sudden […]
• Here are the top 5 medtech stories of mid-2017
  The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from […]
• Reducing production waste with laser profiling and characterization
  Mark Szorik, MKS Instruments As a general rule, most industries preparing a production line run a few sacrificial products, and then, if all checks out, begin running production. This is all well and good until the unexpected hits product quality or volume – or both. When something malfunctions on a modern, precision, high-speed process, it can […]
• FDA commissioner proposes new program for digital health product regulations
  By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to roll out a new program for mobile medical apps and related digital health products in order to clarify the agency’s regulatory scope regarding these technologies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
• HP’s new 3D printers: Here’s why Proto Labs likes them
  Quick-turn manufacturer Proto Labs is among a number of companies testing the new HP Multi Jet Fusion technology for industrial-grade 3D printing. “As far as what we’re testing in, it is definitely becoming a faster way to build parts compared to [selective laser sintering],” Joe Cretella, an applications engineer at Proto Labs (Maple Plain, Minn.), told MDO […]
• Medtech stories we missed this week: June 23, 2017
  From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for […]
• Clever catheter lets surgeons see inside arteries to trim plaque
  The Pantheris catheter developed by Avinger takes the physician out of the radiation field. A clever catheter design lets cardiologists see inside arteries and precisely remove plaque from diseased tissue. The Pantheris catheter is safer than conventional radiation-guided procedures because it takes the surgeon out of the radiation field, and along with on-board optics, it […]