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From Medical Design & Outsourcing

• KCI launches multiple-wound NPWT device for military
  KCI has launched its V.A.C.RX4 Therapy System in the U.S. for civilian healthcare professionals. The system was originally designed for the U.S. Air Force and the U.S. Department of Defense to help military personnel treat multiple wounds on the battlefield with a single negative pressure wound therapy device. “In trauma centers and burn units, physicians… […]
• 6 things you need to consider when adding connectivity to a medical device
  Tim Gee, Medical Connectivity Consulting A manufacturer who wants to add connectivity to an embedded medical device must make some obvious technology changes, such as networking, wireless radios and often, application software and systems integration with EMRs and other systems. The less obvious impact is on company operations, or the business delivery system. This includes… […]
• Medical device industry regulation is changing: What you need to know
  The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants.… […]
• Diversified Plastics acquires Pacific Plastics Injection Molding
  Diversified Plastics announced today that it has acquired the assets of Pacific Plastics Injection Molding (PPIM) in Vista, Calif. The financial details of the deal were not disclosed. PPIM currently offers custom plastic injection molding, design and custom mold making services for the medical, industrial, electronics, filtration and telecommunications markets. “The acquisition of PPIM provides… […]
• FDA opts not to change device class definitions
  The medtech industry appears to have won a round in the regulatory arena. The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the classification of… […]
• Pear Therapeutics wins FDA nod for digital opioid addiction treatment app
  Pear Therapeutics has received FDA 510(k) clearance for its reSET-O medical application that helps treat patients who have an opioid use disorder. The reSET-O app is a prescription cognitive behavioral therapy that is designed to be used with outpatient treatment and under the care of a healthcare professional. It is also designed to be used… […]
• Garmin, ActiGraph ink deal for clinical trial wearables
  Garmin and ActiGraph are collaborating to create a health and activity monitoring solutions for clinical trials. The two companies would use Garmin wearables with ActiGraph’s CentrePoint data analytics platform for academic research, clinical trials and remote patient monitoring. “Garmin Health is excited to work with a global recognized company like ActiGraph that shares an engineering… […]
• Hologic’s Cynosure launches TempSure in North America
  Cynosure has launched its TempSure Surgical RF technology in North America. The company has also re-launched its TempSure Vitalia hand pieces and probes and will continue to market the MonaLisa Touch CO2 laser. The TempSure Surgical RF technology gives clinicians the ability to perform surgical and non-surgical aesthetic procedures across a variety of specialties on… […]
• Renerva lands $2.4 million to develop ‘Neosporin of nerve repair’
  Nerve-repair startup Renerva said today it has received $2.4 million in funding from the U.S. Department of Defense. The Pittsburgh company is developing a periheral nerve matrix (PNM), an injectable gel derived from porcine tissue to help repair and regenerate injured peripheral nerves. The Medical Technology Enterprise Consortium (MTEC) Award award will enable Renerva to complete its preclinical… […]
• Here’s how Intuitive Surgical is innovating to stay competitive
  Intuitive Surgical (NSDQ:ISRG) isn’t resting on its laurels when it comes to the surgical robotics field that it dominates. The Sunnyvale, Calif.­–based company is seeking to stay competitive through technologies including computer-controlled navigated robotic catheters, contrast agents to improve imaging during procedures, and intelligent surgical interfaces. That was a big message that hundreds of attendees heard during… […]
• Will Acelity go public again?
  Privately held Acelity may go public again, according to news reports this week. London-based Apax Partners and a pair of Canadian pension funds acquired wound-care company Kinetic Concepts Inc. (now Acelity) for $6.1 billion in a leveraged buyout in 2011.  Apax is now mulling an initial public offering for Acelity by mid-2019, Bloomberg and the San Antonio Express-news reported.… […]