As more surgical robots are cleared in the U.S. — including Medtronic’s Hugo system, which also received the FDA’s nod in December — CMR claims to have the second most widely used platform in the world. Robotic surgery pioneer Intuitive Surgical remains at the top.
The growing momentum reflects surgeons’ confidence in the platform, CEO Massimiliano Colella said in a statement. The system is currently used in hospitals in more than 30 countries, in specialties that include general surgery, colorectal
A new wave of surgical robotics companies, intent on improving patient outcomes and making less-invasive procedures more accessible and affordable, is driving innovation in the sector.
This next generation of small to midsize companies is advancing platforms that tackle barriers such as hospital infrastructure limitations and surgeon shortages in certain specialties. Some aim to expand use of robotics into more complex areas, including in cardiac surgery and neurosurgery.
Physicians use X-ray fluoroscopy and 3D transesophageal echocardiography to visualize the heart and device during TEER procedures. However, the technologies create two separate images. The surgical team must interpret where the device is in the body based on the two images, potentially leading to miscommunication and suboptimal device placement.
Philips designed its software to combine the outputs of the two imaging modalities to continuously show the location of the device in the body. By visualizing
The medtech company has been working to restore manufacturing, ordering and shipping operations since it was hit by a cyberattack on March 11.
Stryker has restored most manufacturing sites and critical lines roughly two weeks after the company suffered a cyberattack.
The company is working with its global manufacturing sites as “operations steadily improve towards full capacity,” a spokesperson said in a statement emailed to MedTech Dive. Stryker is making “strong progress” on restoring underlying
Abbott developed Triclip to enable surgeons to repair tricuspid valves that no longer close properly and therefore allow blood to leak back into the right atrium of the heart. Edwards Lifesciences won FDA approval for its transcatheter valve replacement device, Evoque, earlier this month.
J.P. Morgan analysts see “a place for both repair and replacement.”
On Tuesday, a panel of experts convened by the FDA will discuss whether the data on Triclip show it is a safe, effective option for valve repair.
Invitae has hired restructuring advisers as it explores strategic options, including a potential bankruptcy filing, the Wall Street Journal reported Monday, citing unnamed sources familiar with the matter.
The genetic testing company could file for bankruptcy within weeks, according to the Journal report.
Invitae is working to strengthen its balance sheet, and its board of directors formed a special committee focused on improving the company’s capital structure, a spokesperson told MedTech Dive
Patients with chronic back pain have traditionally received physical therapy and medication when they first present with symptoms. However, patients can stop responding to the interventions or suffer side effects and have poor long-term outcomes. The limitations of traditional options have created a need for new ways to manage low back pain, the leading cause of disability globally.
SCS is an established option for patients who continue to experience chronic back pain after surgery. The technology
Hemodiafiltration has existed since at least the early 1970s and has been linked to benefits including better cardiovascular stability and improved clearance of certain molecules. Fresenius added to the evidence 10 years ago with a clinical trial that reported a 30% reduced risk of all-cause mortality in people treated with hemodiafiltration.
Use of the technique varies by geography. In 2017, more than one-quarter of hemodialysis patients were on hemodiafiltration in Europe, compared
The FDA has looked into pulse oximeter inaccuracy over the past several years, posting a warning in 2021 and holding an advisory panel meeting earlier this month. The agency has discussed the potential for results to be affected by factors including skin pigmentation and perfusion.
Masimo, a manufacturer of pulse oximeters, has worked to show if its devices suffer from biases. In its announcement, Masimo cited a 2023 study showing its RD Set device performed similarly in people with dark
