Medical Technology News | MedTech Dive
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Abbott ramps up Libre 3 production amid shortages
Sep 20, 2024 · 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.
Abbott and Dexcom are launching the first over-the-counter …
Jun 26, 2024 · The new devices could allow the companies to reach about 25 million people in the U.S. with Type 2 diabetes who don’t take insulin, 15 million people who have been diagnosed with pre-diabetes and an estimated 85 million people who have undiagnosed pre-diabetes, William Blair analyst Margaret Kaczor Andrew said in an interview.
Medical Device News - MedTech Dive
6 days ago · Medical device safety in spotlight after high profile recalls. 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. By MedTech Dive staff.
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose ...
Jul 26, 2024 · Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday. Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect ...
MedTech Mergers & Acquisitions | MedTech Dive
Nov 6, 2024 · 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.
FDA flags 428 spinal cord stimulator patient deaths, urges more …
Sep 4, 2020 · The 107,728 MDRs received by FDA in the four-year period following July 27, 2016, include reports of 428 individual deaths of patients implanted with SCSs between 2005 and 2020. Almost one-third of cases where times to event were available happened in the 30 days after implantation. Many of the patients had comorbidities and the average age was ...
Tandem CMO shares Mobi feedback, expansion plans
Jul 29, 2024 · Ensuring product safety in the medtech industry. MedTech Dive caught up with Tandem Chief Medical Officer Jordan Pinsker after ADA to talk about early feedback on Mobi, plans for additional features and how the company is thinking about market expansion with the new pump. Tandem declined to share sales projections for the device because it is ...
The top medtech trends in 2024 | MedTech Dive
Jan 31, 2024 · 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.
Synchron brain-computer interface implanted in first 6 US patients
Sep 6, 2023 · 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 ...