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.
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 ...
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 ...
MedTech Mergers & Acquisitions | MedTech Dive
Nov 6, 2024 · Edwards continues M&A spree with Genesis’ TAVR tech. Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech. By Susan Kelly • Aug. 19, 2024. The latest news in mergers and acquisitions in the medtech industry.
Boston Scientific’s spinal cord stimulators approved for non …
Feb 7, 2024 · Boston Scientific has won approval for its Wavewriter spinal cord stimulator (SCS) systems in non-surgical back pain (NSBP). The U.S. Food and Drug Administration approval expands the label of the Wavewriter systems to cover the treatment of chronic low back and leg pain in people without prior back surgery. The company announced the approval ...
Owens & Minor inks $1.36B takeover of Rotech - MedTech Dive
Jul 25, 2024 · Owens & Minor on Tuesday agreed to buy home medical equipment company Rotech Healthcare Holdings for $1.36 billion. Orlando, Florida-based Rotech has more than 4,200 employees and provides products and services in 46 states. The takeover is expected to close by the end of 2024. Rotech is “fairly heavily deep into sleep and oxygen,” Jonathan ...
Boston Scientific looks to new devices in 2024 to drive growth
Oct 26, 2023 · 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.”
Exact Sciences wins FDA approval for Cologuard Plus colorectal …
Oct 7, 2024 · Dive Insight: Cologuard Plus “sets a new bar in non-invasive stool-based screening,” Leerink analysts said in a note to investors on Friday. Exact Sciences expects to market the test at 95% sensitivity and 94% specificity, the analysts said. Leerink analysts highlighted the improvement in specificity, which is 87% for the older test, as a ...