Medical Devices: Page 130
-
Abbott wins breakthrough tag for fully implantable LVAD system, following Medtronic
Abbott and Medtronic, whose HeartMate and HeartWare go head-to-head in the left ventricular assist device market, each have FDA's help in getting a less cumbersome version of the treatment to patients with advanced heart failure.
By Maria Rachal • Feb. 4, 2020 -
Zimmer's Rosa robot drives Q4 growth, restructuring set
But the company did not specify total knee system placements like robotics competitor Stryker. It's going to "take a while to disrupt that inertia" from rival systems, CEO Bryan Hanson told investors.
By Maria Rachal • Updated Feb. 4, 2020 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Contura nabs FDA nod for female incontinence device
The London-based company may compete with Allergan, which also sells a bulking agent.
By Susan Kelly • Feb. 4, 2020 -
Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe
The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.
By Nick Paul Taylor • Feb. 4, 2020 -
Its DOJ case settled, ResMed tops revenue expectations in Q2
The sleep apnea device maker also acquired software company SnapWorx to bolster its Brightree business.
By Susan Kelly • Feb. 3, 2020 -
Medtech in limbo as Brexit arrives
Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”
By Nick Paul Taylor • Feb. 3, 2020 -
J&J hit with $344M verdict in California pelvic mesh trial
The false and deceptive marketing decision dwarfs the $117 million settlement a coalition of more than 40 states reached in October.
By Maria Rachal • Jan. 31, 2020 -
Courtesy of Edwards Lifesciences
Edwards saw US TAVR procedures spike 40% in Q4
The question now is whether the broader transcatheter aortic valve replacement market can maintain the bar set by the explosive end to 2019.
By Nick Paul Taylor • Jan. 31, 2020 -
Abbott wins 1st EU approval for transcatheter mitral valve replacement device
The CE mark for Tendyne expands Abbott's mitral regurgitation foothold as further competition from Edwards and Boston Scientific on valve repair and replacement looms.
By Maria Rachal • Jan. 30, 2020 -
5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common
Separately, a pair of cardiologists in an editorial published this week in the journal Circulation noted potential "important differences" between Edwards' Sapien 3 and Medtronic’s CoreValve devices.
By Nick Paul Taylor , Maria Rachal • Jan. 30, 2020 -
Major conglomerates 3M, GE, Philips bet on healthcare
The corporate giants' earnings reports this week indicate medical segments are increasingly important to strategy as other businesses decline.
By Nick Paul Taylor • Jan. 30, 2020 -
UK moves to mitigate impact of notified body withdrawals
Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.
By Nick Paul Taylor • Jan. 30, 2020 -
Robot sales spike to new high as Stryker eyes growth in Japan
As Stryker keeps integrating K2M into its spine business and works to close the upper extremities-driven Wright Medical buyout in 2020, momentum with Mako robot sales is helping orthopaedics share.
By Maria Rachal • Jan. 29, 2020 -
FDA clears Eko's stethoscope algorithms for AFib, heart murmur screening
The authorization gives primary care physicians an enhanced tool to screen for serious heart conditions, with the aim of speeding diagnosis and treatment.
By Susan Kelly • Jan. 29, 2020 -
Abiomed device controversy revived in Circulation editorial
Experts flagged key limitations in a study suggesting the Impella device is pricier and more dangerous than intra-aortic balloon pumps, and highlighted an "urgent need" for randomized clinical trials.
By Nick Paul Taylor • Jan. 29, 2020 -
Philips and ResMed may lose share in growing market for sleep tech: survey
Four dozen home medical equipment companies surveyed by analysts at Needham expect sleep patient volumes to grow 15% in the next 12 months, but market leaders may face pressure from smaller competitors.
By Nick Paul Taylor • Jan. 28, 2020 -
After subdued year for new spinal cord stim tech, industry seeks 2020 rebound
Medtronic, Abbott, Boston Scientific and others that presented at the North American Neuromodulation Society meeting hope an influx in new products will help restore market growth.
By Maria Rachal • Jan. 27, 2020 -
FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections
In a draft guidance on the irrigation tubing used across minimally invasive joint procedures, the regulator said without proper design, testing and risk mitigation, backflow of patient fluid can present risk for disease transmission.
By Maria Rachal • Jan. 27, 2020 -
Smith & Nephew acquires Tusker's PMA-winning ear infection device for ENT portfolio
The buyout of Tusker Medical comes two months after it won FDA premarket approval for an ear tube delivery system that can be used in young children with local anesthesia alone in a doctor's office.
By Maria Rachal • Jan. 24, 2020 -
Intuitive eyes new surgery types as competitive pressure looms
As noise from robotic surgery newcomers grows, Intuitive is prioritizing wider use of da Vinci in hernia repairs, colorectal procedures and bariatrics.
By Maria Rachal • Jan. 24, 2020 -
Moody's predicts cardiology tech to outpace rest of medical devices, driven by TAVR
The rating agency's report coincided with a more downbeat near-term forecast by Jefferies analysts, who tracked "a sharp step down in December growth" of transcatheter aortic valve replacement system utilization by hospitals.
By Nick Paul Taylor • Jan. 24, 2020 -
GE cybersecurity flaw gets maximum risk score, triggering rare FDA notice
"An attacker could potentially silence an alarm that is intended to communicate vital information about a patient to health care staff, such as a patient's cardiac status," the agency wrote of an issue with certain tech platforms.
By Nick Paul Taylor • Jan. 24, 2020 -
3 more notified bodies coming soon, EC says as MDR clock ticks down
New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.
By Nick Paul Taylor • Jan. 23, 2020 -
Surgical gown recall sets Cardinal back $96M
The company estimates a $96 million second quarter charge related to the recall, amid two new field actions affecting procedure kits with the gowns. Cardinal previously saw red flags with the supplier at the root of the problem.
By Nick Paul Taylor • Updated Jan. 31, 2020 -
Abbott ups 2020 growth targets, downplays Libre 2 delay
After exceeding the high end of its 2019 sales forecast on success in electrophysiology, heart failure, structural heart and diabetes, the company forecasts up to an 8% rise in organic growth this year.
By Maria Rachal • Jan. 22, 2020
Previous
