Baxter (NYSE:BAX) issued an urgent medical device correction for its Life2000 ventilation system due to potential oxygen desaturation. Patient oxygen desaturation (low blood oxygen) events can occur under certain conditions. These may happen when the Life2000 system connects with a third-party oxygen concentrator. Hillrom — acquired by Baxter for $12.5 billion in 2021 — manufactures […]
Insulet to replace Silicon Valley Bank in the S&P 500
S&P Dow Jones Indices announced that Insulet (Nasdaq:PODD) is set to replace Silicon Valley Bank in the S&P 500 index. The change becomes effective prior to the opening of trading on Wednesday, March 15. It adds Insulet to the index tracking 500 large companies listed on stock exchanges in the U.S. Silicon Valley Bank’s deletion […]
The medtech companies potentially affected by Silicon Valley Bank’s closure
U.S. banking regulators’ latest moves may provide some reassurance for medtech and other companies exposed to Silicon Valley Bank‘s closure. The California Department of Financial Protection and Innovation shuttered SVB on March 10 to stave off what was turning into an old-fashioned bank run. Silicon Valley Bank has been a huge name in the tech […]
FDA clears Essenz heart-lung machine from LivaNova
LivaNova (Nasdaq:LIVN) announced today that it received FDA 510(k) clearance for its Essenz heart-lung machine (HLM). With clearance, the London-based company initiated its U.S. commercial launch for Essenz, too. It recently received approval for Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In February, LivaNova kicked off a limited […]
DOJ charges former Stimwave CEO over alleged non-functioning neuromod implant
The U.S. Justice Dept. (DOJ) announced today that it filed a two-count indictment charging former Stimwave CEO Laura Perryman, claiming a scheme around the company’s neuromodulation technology. Damian Williams, the United States Attorney for the Southern District of New York, Michael J. Driscoll, the Assistant Director in Charge of the New York Field Office of […]
Interventional Systems announces endourology venture with surgical robot tech
Interventional Systems announced a new venture — called LARC Robotics — aimed at using surgical robotics for percutaneous renal access. Austria-based Interventional Systems said the unit simplifies percutaneous renal access in percutaneous nephrolithotomy (PCNL) procedures. This minimally invasive surgical technique helps to manage kidney stones. The company said in a news release that Dr. Udo […]
Stryker launches Mako Total Knee 2.0 surgical robotics platform
Stryker (NYSE:SYK) announced that it launched the Mako Total Knee 2.0 as part of its Mako SmartRobotics portfolio. Kalamazoo, Michigan-based Stryker unveiled Mako Total Knee 2.0 at the AAOS 2023 Annual Meeting in Las Vegas. It designed the system to deliver the same, trusted outcomes surgeons expect from Mako. However, informed by more than 500,000 procedures, […]
Lenire non-invasive neuromod for tinnitus wins FDA de novo nod
Neuromod Devices announced that the FDA granted de novo approval to its Lenire neuromodulation device for treating tinnitus. According to a news release, Lenire becomes the first bimodal neuromodulation device of its kind to receive FDA approval for treating tinnitus. “Lenire’s approval not only means that millions of Americans living with tinnitus can get the […]
11 of the biggest medtech earnings stories from Q4 2022
Layoffs, growth and more — the biggest medtech companies in the world experienced a range of outcomes in the fourth quarter of 2022. Over the past two months, many of the largest medtech companies across the globe reported their financial results for the three months ended Dec. 31, 2022 (with a handful of exceptions due […]
DeviceTalks Boston early-bird rate expires today
Today is the final opportunity to secure the early-bird rate to register for DeviceTalks Boston. The rate will jump from $395 to $695 where it will stay until the day of the May 10-11 conference, which will be held at the Boston Convention & Exhibition Center. DeviceTalks Boston promises to deliver two days of networking, […]
Study supports RenovoRx drug-device combo for treating pancreatic cancer
RenovoRx (Nasdaq:RNXT) today announced promising interim data for its RenovoGem drug-device combination for treating pancreatic cancer. The Tiger-Pac clinical trial investigates RenovoGem as a potential treatment option in locally advanced pancreatic cancer (LAPC). Interim data from the Phase III open-label study suggests a six-month potential improvement in median overall survival with RenovoGem. RenovoGem utilizes the […]