Owens & Minor (NYSE:OMI) company ArcRoyal issued an urgent field safety notice in Europe to warn of an issue with ethylene oxide (EtO) residue in custom procedure trays that contain an insufflation tubing set with gas from Karl Storz. Karl Storz initiated the recall, noting that the affected products contained increased residues of the carcinogenic sterilant […]
Surgical
Johnson & Johnson planning a robotic surgery reveal in May
Johnson & Johnson (NYSE:JNJ) appears to be preparing a preview of its robotic and digital surgery plans at a Medical Device Business Review Day that the company is planning May 13 in New York City. “We think it will provide a very clear, transparent kind of tangible evidence of not only the machines but also the […]
TransEnterix scores another leasing agreement for Senhance robot
TransEnterix (NYSE:TRXC) this week announced that the Klinikum Esslingen hospital near Stuttgart, Germany, has agreed to lease a Senhance robotic surgery system — the third leasing agreement in about three months for the company. Leasing robot-assisted surgery systems instead of selling them is an important strategic shift for TransEnterix as it seeks a turnaround in 2020. […]
Onkos Surgical partners with Integrum for OPRA Implant System
Onkos Surgical this week announced it signed a multi-year agreement with Integrum to expand to market for Integrum’s OPRA Implant System. The collaboration is expected to commence immediately and will focus on expanding the U.S. market for Integrum’s Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System. “We are delighted to partner with Dr. […]
Miach names new VP of manufacturing
Connective tissue repair implant maker Miach Orthopaedics announced that it named Stephen Wohlert as its new vice president of manufacturing. A 15-year veteran of the medical device and over-the-counter drug concept and product development space, Wohlert recently served as the director of research & development at Professional Disposable International. He also held the same position […]
Robocath performs first robotic coronary angioplasties in Germany
Robocath announced today that it completed the first robotic coronary angioplasties with its R-One robotic catheter guidance system in Germany. Professor Michael Haude, director of Medical Clinic I at Rheinland Klinikum Neuss Lukaskrankenhaus, and his team, performed the percutaneous coronary interventions with the R-One system. Rouen, France-based Robocath CEO Lucien Goffart believes the procedures in […]
Cardinal Health has a surgical gowns contamination problem
The FDA announced that it is working to assess quality issues surrounding surgical gowns and the PreSource procedural packs that contain them, all produced by Cardinal Health (NYSE:CAH). Both Dublin, Ohio–based Cardinal Health and the FDA agree that customers should immediately discontinue the use of all affected gowns and the packs that include them because the […]
Phoenix Children’s Hospital to deploy Medtronic neurosurgery robot
Phoenix Children’s Hospital will be the first health system in the U.S. to deploy the newly FDA-cleared Medtronic Stealth Autoguide platform to perform robotic neurosurgery on pediatric patients. The Barrow Neurological Institute (BNI) at Phoenix Children’s will use Stealth Autoguide with Medtronic’s StealthStation system. The hospital expects procedures to start later this month, according to […]
Pentax Medical launches Imagina endoscope in U.S.
Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch. The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the […]
Embody lands $2.5m from DARPA
Soft-tissue repair treatment developer Embody announced that it has landed a $2.5 million grant from the Defense Advanced Research Projects Agency (DARPA). The latest DARPA funding brings Norfolk, Va.-based Embody’s total DARPA non-dilutive funding to nearly $14.4 million, according to a news release. Embody plans to use the Phase II Small Business Innovation Research (SBIR) […]
Synaptive Medical updates Modus V surgical microscope
Synaptive Medical announced that its U.S. and Canadian Modus V robotic digital microscope now includes updates such as additional 3D visualization and voice-activated control. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex cranial procedures. The Modus V provides […]