Medical Devices: Page 12
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Pulsed field ablation to ‘cannibalize’ radiofrequency, cryo: Needham
Boston Scientific is forecast to gain the largest share of the U.S. ablation catheter market in the next 12 months, at the expense of Abbott and J&J.
By Nick Paul Taylor • June 10, 2024 -
Abbott wins CE mark for dual-chamber leadless pacemaker
Abbott sees the device as a product that can help its rhythm management business grow 6% to 7%.
By Nick Paul Taylor • June 7, 2024 -
Trendline
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 -
Medtronic recalls neurosurgery navigation system for software error
A problem with the Stealthstation S8 could cause incorrect device placement during surgery. It is the fourth recall of Stealthstation software in the past 12 months.
By Elise Reuter • June 6, 2024 -
Sapien valve performs equally well for small and large aortic annuli, Edwards finds
The analysis adds to a debate about the effectiveness of Edwards versus Medtronic TAVR devices in patients with small aortic annuli, a fibrous ring around the heart’s valve.
By Nick Paul Taylor • June 6, 2024 -
Moon Surgical secures FDA nod for commercial soft tissue robot
Moon joins an expanding list of robot makers aiming to compete in a soft tissue surgery market led by Intuitive Surgical.
By Susan Kelly • June 5, 2024 -
Q&A
Stronger oversight of AI needed in medical devices, ECRI CEO says
Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.
By Elise Reuter • June 5, 2024 -
Dexcom connects G7 CGM directly to Apple Watch in US
Apple Watch and G7 users can now view real-time glucose readings on their wrist, regardless of whether they are carrying an iPhone.
By Nick Paul Taylor • Updated June 7, 2024 -
Illumina names Everett Cunningham as chief commercial officer
Cunningham will join Illumina from Exact Sciences to end the six-month search for a permanent leader.
By Nick Paul Taylor • June 4, 2024 -
Stryker inks Artelon buyout to join Zimmer in soft tissue space
BTIG analysts said the takeover could serve as a "defensive mechanism against peers who have been growing rapidly in the space.”
By Nick Paul Taylor • June 4, 2024 -
Abbott receives FDA OK for over-the-counter glucose monitor
After debuting its Lingo device in the U.K. last year, Abbott can now sell the sensor in the U.S.
By Elise Reuter • June 3, 2024 -
Medtech venture capital investing rebounded in Q1
Pitchbook analysts are cautiously optimistic that the funding pickup will continue despite uncertainty about interest rates, heightened regulatory scrutiny and the presidential election.
By Susan Kelly • June 3, 2024 -
Steris to lay off employees in restructuring
Steris said it would cut “less than 300 positions” as it consolidates facilities, continuing the trend of medtechs laying off employees to save costs or reorganize businesses.
By Susan Kelly • May 31, 2024 -
Digital therapeutics firm Akili to sell for $34M
Akili, which makes a video game treatment for ADHD, will merge with Virtual Therapeutics to create a larger digital health entity.
By Elise Reuter • May 30, 2024 -
Fresenius Medical Care plans layoffs ahead of California plant closure
More than 300 people will be affected as the company shifts dialysis manufacturing to a facility in Mexico.
By Elise Reuter • May 30, 2024 -
Medtronic elevates Linnea Burman to president of neurovascular unit
Burman will oversee strategy, product development and financial performance for a unit focused on stroke care.
By Susan Kelly • May 29, 2024 -
Philips reports 7 deaths linked with BiPAP alarm problem
Philips recalled three BiPAP models because an alarm can incorrectly engage and shut down the ventilator under certain circumstances.
By Elise Reuter • May 29, 2024 -
Otsuka defies digital health downturn with new company
With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.
By Elise Reuter • May 29, 2024 -
Q&A
J&J’s Nisha Johnson on Ethizia wound-sealing patch, biosurgery market
With the recent launch of the hemostatic healing patch in Europe, J&J expects to lead the biosurgery and wound closure market.
By Elise Reuter • May 28, 2024 -
New products take center stage in medtech’s latest earnings season
From pulsed field ablation devices to Intuitive's latest da Vinci robot, product launches dominated recent earnings calls.
By Ricky Zipp • May 28, 2024 -
UK regulator proposes recognizing overseas medical device approvals
Companies with authorization in certain regions, including the EU and U.S., would be able to use their approvals to access Great Britain’s market.
By Nick Paul Taylor • May 24, 2024 -
Medtronic touts demand for PFA, adding to hype for the new ablation tech
CEO Geoff Martha told investors there has already been “strong adoption” of PFA devices and the category will be a big part of Medtronic's revenue growth in fiscal year 2025.
By Ricky Zipp • May 23, 2024 -
Hologic recalls more than 53,000 radiographic markers linked to 71 injuries
The Biozorb devices are staying on the market, but Hologic has asked people to report adverse events such as pain.
By Nick Paul Taylor • May 23, 2024 -
Cue Health to lay off remaining employees, shut down
Once a COVID-testing darling, Cue will close after raising hundreds of millions of dollars and striking high-profile partnerships with Google and the NBA during the pandemic.
By Elise Reuter • May 22, 2024 -
Medicare adviser sets recommendations for diabetes device evidence
A MEDCAC panel found time in range was an “extremely important” metric, but members were divided on whether quality of life measures should influence coverage.
By Elise Reuter • May 22, 2024 -
EMA updates advice on drug-device combinations under MDR, IVDR
The European Medicines Agency answered six new questions to clarify topics such as how companies can get advice on borderline products.
By Nick Paul Taylor • May 22, 2024