FDA puts high-risk label on GE Healthcare anesthesia systems recall

A potential loose cable connection in more than 3,600 of the devices may result in a loss of mechanical ventilation.

By Maria Rachal • Feb. 10, 2020

Snapshot: How medtech earnings season is shaping up

Most medtechs offered financial outlooks for 2020 over the last month, but the novel coronavirus could have a longer impact than originally factored in.  

By Maria Rachal • Updated March 6, 2020

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Abiomed, on defense, plans wave of trials to counter Impella criticism

The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.

By Nick Paul Taylor • Feb. 6, 2020

EU MDR notified bodies hit 11 with Irish group added

The National Standards Authority of Ireland describes itself as the country's official standards body. It's the second certified since the Commission teased last month that three more of the entities would soon be added to the count.

By Kim Dixon • Updated Feb. 13, 2020

BD cuts 2020 guidance on Alaris pump hangup with FDA, stock tanks

"Resetting expectations is certainly not how I want to start my first call as CEO," new BD head Tom Polen told analysts. Shares were down as much as 13% Thursday morning.

By Maria Rachal • Feb. 6, 2020

Boston Scientific expects up to $40M hit in Q1 from coronavirus

Ongoing integration of its $4.2 billion acquisition of BTG and pricing headwinds for drug-eluting stents may also temper growth, the company said on its earnings call Wednesday.

By Maria Rachal • Feb. 5, 2020

Merck spins off lower growth products, including contraceptive implants

A yet-to-be-named new company will house the pharma's legacy drugs and women's health products NuvaRing and Nexplanon.

By Jacob Bell • Feb. 5, 2020

Abbott, SynCardia requests prompt CMS to reconsider heart device coverage

Those companies, plus competitors like Medtronic, stand to benefit if the agency expands access to ventricular assist devices and artificial hearts based on new evidence.

By Nick Paul Taylor • Feb. 5, 2020

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

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

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