Intuitive Surgical posted second-quarter results on Thursday that beat the consensus forecast on Wall Street, sending the stock to a record high after markets opened Friday. The Sunnyvale, California-based surgical robotics leader reported profits of $527 million, or $1.46 per diluted share, for the three months ended June 30, 2024, up 25% from the second […]
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Cordis wins FDA nod for vascular closure device
Cordis announced today that the FDA granted premarket approval (PMA) for its Mynx Control venous vascular closure device (VCD). PMA covers the use of the Mynx Control device in in procedures with access sites from 6F to 12F. Mynx Control expands the Cordis portfolio of extravascular closure devices designed to delivery predictable deployment and ease […]
Endiatx plans pivotal trial through Mayo Clinic; Watch their live TED Talk demo
Endiatx is planning a pivotal trial for its swallowable, steerable Pillbot robot camera at Mayo Clinic campuses this year. The Hayward, California–based startup has already started first-in-human trials in New Zealand, Endiatx told MassDevice this week. Endiatx plans to publish data from those trials, saying they are “progressing well, and physicians appreciate the technology.” MDO […]
FDA clears orthopedics robot for TKA from Globus Medical
Globus Medical has won FDA clearance for its new ExcelsiusFlex orthopedics robot stereotaxic surgery in knee procedures and an expanded indication for its ExcelsiusHub system. Audubon, Pennsylvania-based Globus Medical received the 510(k) clearance on June 14 for the robotic positioning system, which was designed to help surgeons position implant components and prepare bony anatomy during […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Cordis reports positive 2-year data for drug-eluting balloon
Cordis today announced positive 24-month results from a study evaluating its Selution SLR drug-eluting balloon (DEB). Selution SLR offers endovascular therapy for de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). Cordis acquired the DEB technology from MedAlliance for $1.135 billion last fall. The company presented data […]
Another Medtronic EVP is leaving the world’s largest device company
Medtronic EVP and Global Regions President Rob ten Hoedt is set to retire on June 28. Ten Hoedt — who is also a member of Medtronic’s Executive Committee — gave notice of his intent to retire from the world’s largest medical device company on June 1, Medtronic said in a single-sentence filing with the Securities […]
Medtronic confirms global layoffs
Medtronic today confirmed a global layoffs first reported last month by MassDevice. At the time, a spokesperson for the world’s largest medical device company declined to confirm the Medtronic layoffs when asked, only saying “Medtronic continually evaluates its operations and aligns our resources with our highest strategic priorities.” Today, the company reiterated that messaging, adding […]
Medline has a serious endotracheal tube recall
The FDA identified a recall of Medline Sub-G endotracheal tubes with subglottic suctioning as Class I, the most serious kind. This recall, initiated in February, includes removing devices from where they are used or sold. It includes six Sub-G endotracheal tubes with subglottic suction and 10 kits that contain these devices. Customers in possession of […]
Abbott wins FDA clearance for its Lingo OTC glucose monitor
Abbott has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable. The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later. FDA clearance for Abbott’s Lingo comes more than […]
Medtronic officials see EPS growth accelerating over the year
Medtronic officials have made important changes to boost earnings growth, and they’re excited about innovations such as pulsed field ablation (PFA) to treat atrial fibrillation (AFib). During the medtech giant’s fourth-quarter earnings call today, CEO Geoff Martha and CFO Karen Parkhill discussed portfolio management moves such as shuttering Medtronic’s ventilators business, more discipline on headcount […]
