Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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RenalGuard Solutions said today that it raised a $14.5 million Series A round for a pivotal trial of its device to prevent acute kidney injury during percutaneous procedures.
The Milford, Mass.-based company’s eponymous device is designed to measure urine output and automatically infuse hydration fluid based on those measurements. It aims to induce high urine rates to protect the kidneys against “a range of insults,” the company said. Read more
Active Implants said today that it banked the 1st $10 million tranche of its $40 million Series D round.
New backer LS Health Science Partners led the round with the 1st tranche and is due to put up another $20 million, with the remaining $10 million slated to come from existing investors, the Memphis-based company said. Read more
The Trump budget plan to slash more than 18% from the budget for the National Institutes of Health sent medical device stocks down today on Wall Street as investors reacted to the proposal.
The budget proposal, released today, would cut the NIH budget by $5.8 billion, to $25.9 billion – an 18.3% cut. The proposal would also introduce “a major reorganization of NIH’s Institutes and Centers to help focus resources on the highest priority research and training activities.” Read more
Zimmer Biomet expects to launch a robot-assisted surgery platform for total knee procedures during the 2nd half of 2018, the company said this week at the annual conference of the American Academy of Orthopedic Surgeons in San Diego.
A prototype of the device, on display at the AOSS conference, is based on the Rosa technology Zimmer Biomet acquired when it put up $132 million for Medtech in July 2016. Montpellier, France-based Medtech developed the Rosa Brain and Rosa Spine robot-assisted surgery platforms; the Rosa Spine device won 510(k) clearance from the FDA early last year. Both Rosa systems have CE Mark approval in the European Union. Read more
The Trump administration’s proposed budget, released today, would double the user fees medical device companies pay to have the FDA review the safety and efficacy of their products.
The budget proposal would set user fees at $2 billion for 2018, about $1 billion more than the fee schedule for this year (annualized to correspond to the calendar year). In return, the budget would contain “a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.” Read more