An increase in the number of surgical procedures taking place at ambulatory care centers could change the playing field for medtech companies, according to a new report by Bain & Co. The management consulting firm predicted that procedures at these stand-alone centers could grow by 6% to 7% annually through 2021, with orthopedic, spine and […]
Surgical
Medtronic finally unveils its new robot-assisted surgery system
Medtronic (NYSE:MDT) claims it has a new robot-assisted surgery platform that is more flexible and cost-effective than systems presently on the market. That appeared to be the message out today from the world’s largest medical device company as it unveiled its much-awaited Hugo RAS system. The system is Medtronic’s answer to a growing market that remains […]
Baylis Medical touts first MitraClip procedure with VersaCross catheter
Baylis Medical said today that it successfully completed the first Abbott (NYSE:ABT) MitraClip procedure with Baylis’ VersaCross transseptal solution catheter. VersaCross is a left-heart access device designed with an atraumatic radio frequency-tipped pigtail wire to achieve access and then serve as an exchange wire, reducing the number of exchanges throughout the procedure. The MitraClip is designed […]
Integra Lifesciences touts Cadence ankle study
Integra LifeSciences (NSDQ:IART) yesterday touted positive findings from its Cadence total ankle system retrospective study and closed enrollment ahead of schedule for two post-market studies of the device. The study reported that patients treated with Cadence while suffering from end-stage arthritis experienced improvements in quality of life, functional measures and pain. The results were presented during […]
FDA clears Viseon’s Voyant spine surgery imaging device
Viseon said today that it won FDA clearance for its Voyant system for integrating minimally invasive surgical access with high-definition imaging technology. Irvine, Calif.-based Viseon’s Voyant technology is billed as an alternative to surgical microscopes, endoscopes and loupes, designed for use in both posterior and lateral-access minimally invasive spine procedures. With real-time, high-definition imaging technology, […]
Covalon closes $6m private placement
Covalon Technologies (TSXV:COV.V) said yesterday that it closed a private placement worth nearly $6 million. Mississauga, Ontario-based Covalon initially priced the offering at about $6.3 million, but re-priced it to approximately $5.5 million earlier this month to reflect the market for its stock. The revised offering, of nearly 2.8 million units (one share and one warrant) […]
FDA clears OrthoSpin’s robot-assisted external fixation device
OrthoSpin has won FDA 510(k) clearance for its robot-assisted external fixation system for orthopedic treatments. Misgav, Israel-based OrthoSpin’s system is designed to automatically make pre-programmed adjustments to eliminate manual adjustments and patient training while reducing the need for follow-ups. The system could change the outcomes of orthopedic treatments such as bone lengthening, setting complex fractures […]
Siemens Healthineers wins FDA nod for Artis Icono angiography line
Siemens Healthineers said yesterday that it won FDA clearance for its Artis Icono angiography systems for performing a wide range of minimally invasive procedures in a single interventional suite. The Artis Icono platform includes a biplane system engineered for neuroradiology and abdominal imaging, and a floor-mounted, single-plane system for vascular, interventional cardiology, surgical and oncology […]
FDA OKS Avita Medical trial for Recell in soft tissue reconstruction
Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell harvesting device. The Valencia, Calif.-based company said the 65-patient study is designed to compare conventional skin grafting with and without Recell system. Each patient is slated for a control wound treated with a conventional […]
Functional Neuromodulation launches Alzheimer’s DBS trial
Functional Neuromodulation said yesterday that it has begun a pivotal clinical trial to assess deep brain stimulation (DBS) in patients with mild Alzheimer’s disease. The Minneapolis-based company said the study will evaluate the safety and efficacy of stimulating the fornix (DBS-f) — a major inflow and output pathway in the brain’s memory circuit. Research suggests […]
EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer
EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure. Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs […]