Johnson & Johnson‘s (NYSE:JNJ) Auris Health touted this week interim results from an independent feasibility study designed to assess the company’s Monarch robotic bronchoscopy technology. The Monarch Platform was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopic procedures. The study was set up to test the safety and feasibility of performing […]
J&J ordered to pay $80 million in Pennsylvania pelvic mesh case
A Philadelphia jury has awarded a woman $80 million for injuries caused by pelvic mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, according to media reports. The award includes $50 million in punitive damages and $30 million in compensatory damages — the largest compensatory damages verdict to date in a pelvic mesh case, a company […]
Merged Smithwise and Catapult rebrand as Archimedic
After announcing their merger last month, medical product development firms Smithwise and Catapult Product Development have rolled out their new brand, Archimedic. “As we brainstormed a new name, we knew we wanted it to reflect the medical device industry we serve,” said Eric Sugalski, CEO of the joint entity, in explaining in a news release how they settled […]
5 ways medtech research aims to help veterans
As the United States prepares to honor its war dead on Memorial Day, medtech researchers are working to help survivors wounded in battle, both in body and mind. Whether the research comes out of government, industry or academia, there’s also a desire to help veterans facing other health challenges. The work is evolving. 3D printing […]
FDA labels Ethicon stapler recall as Class I
The FDA today labeled a select recall of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s Endo-Surgery endoscopic and non-endoscopic curved intraluminal staplers with adjustable height staples as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The affected staplers […]
CMR Surgical touts first-in-human procedures with Versius robotic surgical platform
CMR Surgical said today that it has successfully completed the first-in-human procedures with its Versius surgical robotic system as part of a clinical trial in Pune, India. A total of 30 procedures were performed by Dr. Dhananjay Kelkar and their team at the Deenanath Mangeshkar Hospital & Research Center, The U.K.-based company said that the Versius […]
J&J’s Ethicon buys Takeda’s TachoSil fibrin patch for $400m
Takeda Pharmaceutical (TSE:4502;NYSE:TAK) said yesterday that it’s dealing its TachSil fibrin patch to Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon for $400 million in cash. The Japanese company, which is still digesting last year’s $62 billion acquisition of Shire, said it also agreed to sell its Xiidra lifitegrast ophthalmic solution to Novartis (NYSE:NVS) for $3.4 billion, […]
Is the orthopedic device space in the midst of a robot revolution?
Stryker’s success with its Mako robot-assisted surgery platform has other orthopedic device companies hastening to enter the space. The big question is whether long-term outcomes will justify the expensive technology. More than five years after spending $1.7 billion to acquire Mako Surgical, Stryker is leading the way bringing robot-assisted surgery to the orthopedic space. The […]
Robot-assisted surgery matters for contract manufacturers
Robot-assisted surgery is a game changer, not only for orthopedic device companies but the contract manufacturers serving them. For major supplier Tecomet, it means forging relationships earlier, sometimes tighter instrument tolerances — and much more. It makes sense that Tecomet officials would see the rise of robot-assisted surgery in the ortho space as a big […]
Titan Medical freezes design on Sport robotic surgery platform
Titan Medical (NSDQ:TMDI) said today that it has achieved a design freeze for its single-port Sport robotic surgery platform. The Toronto-based company said that the freeze is the culmination of engineering work based on feedback it received through extensive preclinical feasibility studies and an ongoing formative human factors study. Read the whole story on our sister site, […]
J&J’s Ethicon issues urgent field safety notice over intraluminal staplers
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has released an urgent field safety notice recalling select Intraluminal Staplers distributed in the UK and Ireland over issues with the devices that may affect their performance during surgeries. Ethicon said that after investigating complaints and returned products, it confirmed the occurrence of uncut washers and malformed staples within the recalled […]
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