Insulet today announced positive results from a clinical trial pitting its Omnipod 5 against non-automated insulin therapy. Acton, Massachusetts-based Insulet conducted its first randomized controlled trial showing improved glycemic and patient-reported outcomes in type 1 diabetes with the Omnipod 5 automated insulin delivery (AID) system. The company presented results at the Advanced Technologies & Treatments […]
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Silk Road Medical launches new transcarotid stent in the U.S.
Silk Road Medical (Nasdaq:SILK) announced today that it launched its tapered EnRoute transcarotid stent system in the U.S. Sunnyvale, California-based Silk Road says this expands upon the prior launch of its EnRoute system by adding additional configurations. It better tailors the transcarotid artery revascularization (TCAR) procedure to the patient anatomy. TCAR, a minimally invasive procedure, […]
Profound Medical, Siemens Healthineers collab on ultrasound ablation
Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the […]
How medtech could be affected by a U.S. government shutdown
Editor’s note: This article originally ran on September 29, 2023. It was updated on February 27, 2024 to reflect new staffing contingency plans and which departments will be affected by the March 1 shutdown. Congressional leaders over the weekend did not come to an agreement on legislation to fund several government agencies, including the FDA. […]
BioSig reduces workforce again, will ‘substantially’ cut operations
BioSig Technologies (Nasdaq:BSGM) announced today that it terminated “a significant number of its employees.” Shares of BSGM were up 3.1% to 64¢ apiece in mid-morning trading today following the announcement. With this latest workforce reduction, the company says it expects to “substantially reduce business operations.” Today’s announcement marks the company’s second significant headcount cut in […]
The biggest stories from AAOS 2024
Stryker, Smith+Nephew, Osso VR and more made important announcements at the American Academy of Orthopaedic Surgeons’ annual meeting (AAOS 2024). AAOS 2024, running Feb. 12–16 in San Francisco, was also where a new study raised questions about the benefits of robotic knee surgery. Go to our sibling site Medical Design & Outsourcing to find out […]
FDA clears Viz.ai algorithm for quantifying intracerebral hemmorhage
Viz.ai announced that it received FDA 510(k) clearance for its Viz ICH Plus algorithm for providing volume measurements of brain bleeds. Viz ICH Plus automates the process of identifying, labeling and quantifying the volume of segmentable brain structures on non-contrast computed tomography (NCCT) images. The company designed it to analyze intracranial hyperdensities, lateral ventricles and […]
10 surgical robotics companies you need to know
The surgical robotics space saw a major shakeup last year. “Robotics is hard. Robotics in healthcare is hard.” Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October. It pretty much sums up the situation for medtech companies large and small […]
CMR Surgical CEO expects another year of growth
Nearly a year after year after he took over as CEO at CMR Surgical, Supratim Bose says the surgical robotics company is set for more growth. Over the past year, the Cambridge, U.K.–based maker of the Versius surgical robotic system has moved forward on several vital initiatives to set itself up for success: The development […]
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 […]
Microbot Medical expands U.S. operations to prep for first in-human clinical study
Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its first-in-human clinical trial. The clinical research […]