FSS lands extended CE Mark for FlexStent | Regulatory Roundup

From Medical Design & Outsourcing

• Belmont Instruments acquires Israeli temperature management firm MTRE Advanced Technologies
  Belmont Instrument (Billerica, Mass.) recently acquired MTRE Advanced Technologies. The financial details of the deal were not disclosed. The acquisition allows Belmont to extend its portfolio to include non-invasive body temperature management solutions. MTRE’s normothermia management products include the Allon system and ThermoWrap disposable garment, as well as the temperature management portfolio including the CritiCool system […]
• Medtech venture investing trends: Here’s what you need to know
  Ask any early-stage medtech or digital health entrepreneur, and they’ll tell you how tough it is. There’s tremendous competition for venture investing, coupled with a pullback by previously traditional investors in this space. Bill Evans While venture investment in medtech and digital health has recovered since the financial crisis of a decade ago — setting […]
• Medtech stories we missed this week: June 22, 2018
  From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India […]
• Nitto Kohki touts Cube Cupla couplings
  Nitto Kohki is touting its small and lightweight coupling called the Cube Cupla. The L-shaped Cube Cupla comes in five color variations. It prevents misconnection of piping and has easy and quick piping connection and disconnection. Cube Cupla is ideal for applications such as air piping of muscle compression machines for training and ink piping […]
• White House proposes 30% cut to FDA headcount, reorganization
  The Trump administration this week submitted a proposal that would cut the budget and staff at the FDA, as well as reorganizing the agency to remove food regulation from its purview, according to a new Endpoints News report. The proposal would cut $1.3 billion in resources from the agency and 5,000 members of its staff […]
• Study: No difference in complications, survival rate between robot-assisted and open bladder surgeries
  A seven-year study comparing outcomes from robotic and open cystectomy procedures showed no statistically significant difference in complications or survival rate between the two methods. The randomized open versus robotic cystectomy study, known as the Razor trial, is touted as the first comprehensive study to compare outcomes between robotic and traditional open surgeries in any […]
• Johnson & Johnson hits the Big Apple with latest JLabs site
  Johnson & Johnson (NYSE:JNJ) opened its latest life science incubator in New York City, the healthcare giant said today. The 30,000-square-foot JLabs @ NYC is a collaboration between Johnson & Johnson Innovation, New York State and the New York Genome Center. Sited at the genome center in SoHo, the incubator is home to 26 startups and […]
• This wireless system powers devices inside the body
  Massachusetts Institute of Technology researchers and Brigham and Women’s Hospital scientists have developed a wireless, ingestible system that can power and communicate with devices that are implanted deep within the body. The researchers suggest that the system could be used to deliver drugs, monitor conditions inside the body or treat diseases by stimulating the brain […]
• Resonetics acquires Swiss manufacturer Medelec
  Resonetics (Nashua, N.H.) announced today that it has acquired Medelec (Puidoux, Switzerland). The financial details of the deal were not disclosed. “We are excited about the Medelec team joining Resonetics. Marc and Sandra But have established a very strong reputation in the medtech industry for precision and quality and have made significant investments in technology […]
• Data Sciences International launches inhalation exposure system
  Data Sciences International, a subsidiary of Harvard Bioscience, recently launched a new inhalation and exposure system called the DSI Buxco Inhalation Exposure System. The new inhalation exposure system is designed for ease-of-use for researchers while also giving them flexibility. It features remote sensors and hardware control system that are linked by a microprocessor-based feedback loop. […]
• Medical devices: When should you make them smarter?
  The drive toward value in healthcare has increased demand for smarter medical devices able to provide information for real-time feedback, as well as after-the-fact analysis. So when does it make sense to actually make a medical device smarter? And how do you go about it? Tom KraMer, CEO of Kablooe Design outside Minneapolis, has a […]