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In a draft guidance on the irrigation tubing used across minimally invasive joint procedures, the regulator said without proper design, testing and risk mitigation, backflow of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

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

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

FDA OKs latest Medtronic leadless pacemaker, potentially tripling market

The newest version of the company's transcatheter pacing system, first approved in 2016, expands the device to patients with atrioventricular block.

By Susan Kelly • Jan. 22, 2020

Medical device sales flat, J&J CEO promises big year for robots

A Medical Device Business Review Day scheduled for this spring in New York City will feature "tangible evidence of not only the machines, but also the digital platform component," Alex Gorsky said of J&J's robotic surgery ventures.

By Nick Paul Taylor • Updated Jan. 23, 2020

HHS price transparency efforts may decode only sliver of total spending

A new analysis focused on non-emergency care that a patient can choose deliberately, such as hip or knee replacements, as opposed to emergency services. 

By Ron Shinkman • Jan. 21, 2020

Medline's Illinois sterilization plant comes back online

Having spent $10 million to meet stricter ethylene oxide emissions rules, the facility resumed operations Friday, roughly two months after local health regulators once predicted.

By Maria Rachal • Updated March 30, 2020

UK health authority 'proactively' monitoring breast implant illness reports

In guidance for patients and clinicians on symptoms "sometimes referred to as Breast Implant Illness," the Medicines and Healthcare products Regulatory Agency stopped short of linking the devices to reported illnesses.

By Susan Kelly • Jan. 21, 2020

5 medtech trends to track in 2020

With the medical device tax in the rearview mirror, industry worries include the uncertain future for product sterilization, the "valley of death" between product authorization and reimbursement, and enforcement of new EU regulations.

By Maria Rachal , David Lim • Jan. 17, 2020

Virtual, augmented reality in medicine pique FDA's interest

The agency is hosting a workshop Wednesday with representatives from Microsoft, Facebook, Philips and other industry players in hopes of identifying roadblocks to developing more uses of extended reality for medical purposes.

By Nick Paul Taylor • Jan. 17, 2020

Edwards' US patent challenge to Abbott MitraClip IP denied

In a decision Thursday, the Patent Trial and Appeal Board thwarted Edwards Lifesciences' petition arguing certain Abbott mitral valve repair claims are unpatentable, the latest in a transatlantic battle between the companies.

By Nick Paul Taylor • Jan. 17, 2020

Dexcom talks up Type 2 market, Medtronic says it has 'work to do' in diabetes at JPM

The San Francisco conference featured presentations from most major insulin delivery and glucose monitoring players, preceded by a handful of new funding announcements including a $93 million Series C for Virta Health.

By Maria Rachal • Jan. 16, 2020

Study of Abbott's HeartMate 3 points to single treatment indication for LVADs

A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.

By Nick Paul Taylor • Jan. 16, 2020

ResMed pays more than $37.5M to settle false claims allegations

The settlement covers accusations that the sleep apnea and respiratory conditions medical equipment maker provided free and below-cost products and services to spur patient referrals.

By Nick Paul Taylor • Updated Jan. 20, 2020

REVA files for bankruptcy after bioresorbable scaffold flops

The company pinned its failure to grow sales on the European Society of Cardiology's preference for conventional drug-eluting stents.

By Nick Paul Taylor • Jan. 16, 2020

Amid Q4 letdown, Boston Scientific aims for $1B mark in structural heart

CEO Mike Mahoney, speaking at the J.P. Morgan Healthcare Conference, partly blamed underperformance on a December slowdown in the U.S. defibrillator business, but said the company is still sorting out reasons for the softness.

By Susan Kelly • Jan. 15, 2020

Health IT to lead 2020 deals, KPMG predicts

The repeal of the medical device tax could boost investor interest in hot areas like non-invasive diagnostics, robotic surgery and AI-enabled devices, although health IT, pharma and biotech appear to be drawing more excitement.

By Linda Wilson • Jan. 15, 2020

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.

By Nick Paul Taylor • Jan. 15, 2020

Medtronic at JPM: More tuck-ins under Martha and key trial results ahead

Incoming CEO Geoff Martha also said management agrees "certain pockets of the company probably have a little bit too much bureaucracy."

By Maria Rachal • Jan. 14, 2020