BY JIM HAMMERAND The Da Vinci Xi robotic surgery system. Intuitive continues to dominate the space. [Image courtesy of Intuitive] Intuitive Surgical (Nasdaq: ISRG)+ stock declined after the surgical robotics developer missed on revenue for the third quarter but beat analysts’ expectations on profit. Shares of ISRG dropped 8% to $251 in after-hours trading when Intuitive released the results. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down slightly on the day. The Sunnyvale, California-based surgical robotics leader posted profits of $416 million, or $1.16 per share for the three months ended Sept. 30, 2023. That was a 28% bottom-line gain compared to Q3 2022. The company reported sales of $1.74 billion, up 12% from the same quarter last year. Intuitive attributed the gains to growth in da Vinci surgical robot procedures and an increase in the installed base of systems. Adjusted earnings per share ...
Dive Brief Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices. The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled, and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care. ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages. Dive Insight The Food and Drug Administration currently lists 11 medical devices that are in short supply. More than 120 drugs face shortages, according to another FDA list. The tendency for some products to become hard to source, for reasons such as manufacturing problems and rising demand, predates ...
ohnson & Johnson MedTech Worldwide Chair Tim Schmid [Photo courtesy of Johnson & Johnson] Tim Schmid is the new worldwide chair of Johnson & Johnson MedTech and EVP of Johnson & Johnson (NYSE: JNJ)+ following Ashley McEvoy’s announcement today that she plans to resign from the world’s second-largest medical device manufacturer.“We are pleased to have the depth of talent at Johnson & Johnson that allows us to transition to Tim, a respected, results-driven and Credo-based leader,” J&J Chair and CEO Joaquin Duato said in a news release.McEvoy called Schmid “a trusted friend and partner” in a LinkedIn post announcing her resignation. Schmid has worked for New Brunswick, New Jersey-based J&J for three decades, most recently serving as group chair of J&J MedTech Asia Pacific (APAC).“During his tenure, the APAC region has delivered above-market growth and further strengthened our leadership position across multiple businesses,” J&J said. “Mr. Schmid has also been instrumental in elevating the role ...
Surgery to straighten a crooked septum (the thin wall of bone and cartilage dividing the space between the two nostrils) is more effective than nasal sprays, and should be offered to adults with at least moderate symptoms such as breathing disruption, suggests a UK trial published by The BMJ today.A crooked (deviated) septum often means that one nasal passage is narrower than the other, making it feel blocked, which can affect breathing, sleep or exercising. Surgery to correct this (septoplasty) is a common operation. In 2019-20, 16,700 septoplasties were carried out in England, but there’s a lack of high quality evidence evaluating septoplasty and therefore no clear guidelines for its use.To address this, a team of UK researchers designed the Nasal Airways Obstruction Study (NAIROS) to provide definitive evidence and recommendations for use of septoplasty. Their aim was to inform guidance on which patients may benefit from this treatment, and ...
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
Although people with opioid use disorder (OUD) are significantly more likely to overdose or have a complication after major surgery than those without the disorder, using medications for the treatment of OUD before surgery may eliminate that extra risk, suggests a large, first-of-its-kind study presented at the ANESTHESIOLOGY® 2023 annual meeting. Patients with OUD who didn’t use an OUD medication (such as buprenorphine or methadone) were over four times more likely to overdose after having surgery, yet those who used evidence-based OUD medication before surgery were essentially at no greater risk than those who didn’t have OUD, according to the study. Taken orally, OUD medications reduce withdrawal and cravings and prevent opioids from producing the feeling of euphoria that drives addiction. Anjali Dixit, M.D., MPH, pediatric anesthesiologist at Stanford University, California, said, “We know that OUD treatments are very effective in helping to prevent relapse, overdose and death in nonsurgical ...
What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
The study will offer new insights into the immune system’s response to iGAS Spencer Dayman Meningitis Research has announced that scientists at the University of Bristol have begun a research project to aid in the development of a vaccine against invasive group A streptococcus (iGAS). The study will offer new and unique insights into the adaptive immune response to iGAS. iGAS is a severe infection caused by bacteria invading parts of the body, including the blood, deep muscle, fat tissues or lungs, which can lead to diseases such as meningitis and sepsis. Since April 2023, there have been 3,287 cases of iGAS in the UK, 761 of which occurred in children aged 18 years and under. There is currently no vaccine to protect individuals from group A streptococcus, which can also cause rheumatic fever and scarlet fever. Funded by Spencer Dayman Meningitis Research, scientists Dr Ana Goenka, Dr Alice Halliday ...
BY SEAN WHOOLEY [Image courtesy of DePuy Synthes] Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology. DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use. The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies. DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and ...
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