Medical Technology News | MedTech Dive
Ensuring product safety in the medtech industry. From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety. MedTech Dive news delivered to your inbox. Get the free daily newsletter read by industry experts.
Abbott ramps up Libre 3 production amid shortages
2024年9月20日 · Abbott received FDA clearance for its FreeStyle Libre 3 continuous glucose monitor in May 2022. The company is ramping up production as some people face delays due to high demand. Permission granted by Abbott Laboratories. Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled.
Synchron brain-computer interface implanted in first 6 US patients
2023年9月6日 · Synchron, which is developing a brain-computer interface that aims to restore functionality in people with severe paralysis, said Tuesday that six patients have received the implant in the company’s U.S.-based feasibility study. The milestone marks the completion of enrollment in the COMMAND trial, conducted under the first investigational ...
The top medtech trends in 2024 | MedTech Dive
2024年1月31日 · Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year. Growing procedure volumes and remaining backlogs for certain surgeries could propel device companies to a successful 2024. JohnnyGreig via Getty Images.
MedTech Mergers & Acquisitions | MedTech Dive
3 天之前 · Merit Medical inks $210M takeover of Cook’s lead management business. Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales. By Nick Paul Taylor • Sept. 18, 2024.
Medical Device News - MedTech Dive
2 天之前 · Livanova hits sleep apnea trial goals, plans FDA filing. Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may have a hard time breaking into the sleep apnea market. By Nick Paul Taylor • …
Boston Scientific looks to new devices in 2024 to drive growth
2023年10月26日 · Approvals expected next year. New device approvals next year are expected to drive Boston Scientific’s future growth. The Marlborough, Massachusetts-based company reported 11% revenue growth in the third quarter, leading CEO Mike Mahoney to tell investors on Thursday that “2023 is shaping up to be a great year, a good jumping-off point heading into 2024.”
5 medtech trends to watch in 2024
2024年1月9日 · Industry executives reported improving business trends and a solid operating environment in the third quarter of 2023 on their latest earnings calls. Medtronic, which typically is the last large medtech company to report, even hinted the final months of the year had similar stability. Singh said macroeconomic factors like potential …
5 takeaways from the FDA’s list of AI-enabled medical devices
2022年11月7日 · Here are five takeaways on the rise of these devices. 1. The number of AI-enabled medical devices has surged in the last five years. Number of approvals and clearances by the Food and Drug Administration per year. The number of AI/ML-enabled devices began to increase in 2016, reaching a high of 115 devices in 2021.
FDA finalizes guidance on cybersecurity for medical devices
2023年9月27日 · Dive Insight: Late last year, Congress empowered the FDA to issue “refuse to accept” decisions to applicants that fail to include the information it needs to ensure medical devices meet cybersecurity requirements. The FDA said it “generally intends” not to use that power before Oct. 1. After that, the agency expects sponsors “will have had sufficient time to prepare premarket ...