Abiomed shares sink as FDA votes to keep Impella pump at highest risk level

From Medical Design & Outsourcing

• LiveNova wins FDA clearance for mitral annuloplasty ring
  LivaNova recently announced that it has received FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring. Memo 4D is the next generation of devices in the company’s Memo device family. It comes in a wide range of ring sizes from 24 to 42mm, allowing for more patients with mitral regurgitation to get treatment. […]
• 5 things medtech manufacturing executives learned from their dads
  Sometimes working for your dad seems like destiny, but taking over the family business wasn’t always the plan. There are many second- and third-generation medtech manufacturers run by executives following in their dads’ footsteps. Here’s what they learned.  Eric Crainich, president and owner of Design Standards (Charlestown, N.H.), was told from a young age that […]
• These nanorobots clear bacteria and toxins from blood
  Researchers at the University of California at San Diego have created tiny ultrasound-powered nanorobots that are designed to swim through blood and remove bacteria and toxins. The UCSD researchers built the nanorobots using gold nanowires coated with a hybrid of platelet and red blood cell membranes. The hybrid coating meant the nanorobots can perform two […]
• Mack Molding investing millions into N.C., Vermont facilities
  Mack Molding (Arlington, Vt.) recently announced that it is hiring and investing millions of dollars at its Statesville, N.C. facility and its three Vermont locations. “The resurgence of manufacturing in the United States is strong, and Mack has been aggressive in ensuring we are well-positioned to seize the opportunity presented to us,” Jeff Somple, Mack’s president, […]
• Medtech stories we missed this week: June 15, 2018
  From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]
• Keystone Electronics touts UL recognized, quick-fit terminals
  Keystone Electronics is touting its UL recognized, male and female, PCB quick-fit terminals, as well as its male rivet mount quick-fit terminals. The quick-fit terminals are designed to withstand repeated mating cycles. The PCB mountable terminals have a Sturdi-Mount design that increases its mounting strength and stability by maintaining the terminal’s perpendicularity to PCBs during […]
• Mean Well expands high-performance medical power supply line
  Mean Well recently announced that it has extended its MSP line up to 1000 W with its MSP-1000 series. The MSP-1000 series shares the same mechanism of Mean Well’s MSP-600 series, according to the Fremont, Calif.–based company. The shared mechanism means that customers are able to replace a 600 W power supply with a 1000 W […]
• GW Plastics increases scientific molding process development capabilities
  GW Plastics recently announced that it has expanded and upgraded its process development and training center in its Royalton, Vt. location. The upgrade allows the facility to develop and debug entire manufacturing cells in a dedicated non-production facility. The expansion takes place during the company’s 20th anniversary of the process development center that received RJG […]
• Adhesives and medical devices: How to make sure things don’t go wrong
  Too often the adhesive selection for a medical device is left to the end of a project. It doesn’t help that there are so many adhesives as to make the choice overwhelming. With so many potential negative outcomes, here are tips on making the right choice. Tony Kaufman and Del R. Lawson, Critical and Chronic Care […]
• Traco Power announces 3.5 W medical dc-dc converters
  Traco Power recently announced the release of their TIM 3.5 and TIM 3.5SM families of medical 3.5 W DC/DC converters  — in compact DIP 16 or SMD 16 package that measures only 0.95 x 0.57 x 0.40 in. The new converters are ideal for healthcare products where small size is required and parts are applied […]
• Here’s how FDA officials think you can legally promote off-label device, drug uses
  The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the […]