Anika extends deal with UMass Amherst to develop rheumatoid arthritis therapy

From Medical Design & Outsourcing

• FDA, FTC warn companies over deceptive opioid cessation products
  The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is […]
• Why customer-centric marketing isn’t enough for medtech
  Customer-centric marketing has been a key pillar of marketing strategies across industries in recent years. But in medtech, the marketing ecosystem is a little more complicated. Rachel Mele, Vennli Customer-centricity has been a key pillar of marketing strategies across industries in recent years. In 2016, nine in 10 CMOs said their organizations were trying to become […]
• FDA’s digital health plan shakes up FDA’s review process
  FDA is asking questions about how to overhaul digital health product regulation and relying on expertise within the industry to do so, according to Bakul Patel, FDA’s associate center director for digital health, who recently spoke with MDO. In late 2017, FDA launched the Digital Health Innovation Action Plan. Within that plan is a recipe […]
• 3 secrets of medtech success from a true industry pioneer
  From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career. Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him speak at DeviceTalks West […]
• Report: CMS nixes plans for pathway for expedited medical device coverage
  The Centers for Medicare & Medicaid Services has cancelled plans to create a new regulatory pathway that aimed to accelerate medicare coverage for medical devices, according to a ModernHealthcare report. The federal agency reportedly withdrew the proposition, known as Excite, from review at the White House’s Office of Management and Budget this month, nine months after […]
• 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 […]