Edwards expects TAVR demand to fuel double-digit growth in 2019

The company predicts 11% to 15% TAVR growth for the second year in a row.

By Nick Paul Taylor • Dec. 6, 2018

FDA seeks to boost use of De Novo pathway with proposed rule

The increased clarity intended for the regulatory framework and application process could incentivize manufacturers to establish new predicates, aligning with the agency's plan to phase out older ones.

By Maria Rachal • Dec. 5, 2018

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

ResMed buys maker of COPD, asthma monitoring platform

The acquisition of Propeller follows a growing trend by device makers to acquire or partner with digital technology companies. 

By Susan Kelly • Dec. 5, 2018

Medtronic subsidiary to pay $17.9M in DOJ settlement

Following a federal probe, Medtronic-owned medical device company ev3 pleaded guilty to charges related to marketing a neurovascular medical device for unproven and potentially dangerous uses.

By Maria Rachal • Dec. 5, 2018

FDA classifies Medtronic's ventilator correction a Class I recall

The software update addresses user interface problems that led Australian regulators to suspend the device.

By Nick Paul Taylor • Dec. 5, 2018

OIG finds Medicare overpaid $34M to device suppliers over three years

The overpayment stems from improper billing for prosthetics and other devices used at inpatient facilities.

By Nick Paul Taylor • Dec. 5, 2018

Medtronic AFib study combines hot, cold ablation techniques

Atrial fibrillation treatments are a high-growth business for Medtronic, which competes against Boston Scientific and Abbott in the $4 billion market.

By Susan Kelly • Dec. 4, 2018

Medtech R&D adapting under new pressures, industry study shows

The shift to value-based payment models and already tight profit margins are ratcheting up pressure, but the device makers are adjusting their R&D investment strategies in response.

By Susan Kelly • Dec. 4, 2018

8 medtech companies get leg up from FDA for opioid devices

Winners of the agency's Innovation Challenge to combat opioid abuse now have access to closer collaboration with FDA as they look to jointly fast track their products to market. 

By Maria Rachal • Dec. 4, 2018

Company of the Year: Boston Scientific

Neuromodulation, endoscopy, urology and peripheral interventions businesses are all generating double-digit revenue increases, driving companywide growth to an expected 8% finish for the year.

By Susan Kelly • Dec. 3, 2018

The MedTech Dive Awards of 2018

The awards recognize the industry's top disruptors and newsmakers. These officials and companies are shaking up the medical technology sector and shaping the future.

By MedTech Dive Team • Dec. 3, 2018

FDA's De Novo pathway is about to get a makeover

"Particularly with really low risk devices, it can be challenging both from FDA's perspective and industry's perspective in terms of how much data is needed," Allyson Mullen, an attorney at Hyman, Phelps & McNamara told MedTech Dive.

By Meg Bryant • Dec. 3, 2018

FDA issues draft guidance on blood glucose monitors

The agency said distinguishing between test systems used in healthcare settings and those for use by patients at home will improve product safety and effectiveness of the devices.

By Susan Kelly • Nov. 30, 2018

GE, VA partner to accelerate creation of 3D medical models

The use of software tailored to the medical sector is expected to slash model creation timelines.

By Nick Paul Taylor • Nov. 30, 2018

Canada vows to strengthen device regulation following media probe

More stringent approval requirements and the mandatory publication of clinical data are among the changes being discussed.

By Nick Paul Taylor • Nov. 30, 2018

Why political contributions linked to a little-known hearing aid firm topped medtech giants

Spending connected to Starkey Hearing Technologies surpassed Medtronic, Boston Scientific and Edwards Lifesciences during the 2018 election cycle.

By David Lim • Nov. 29, 2018

Zimmer Biomet recalls spine fusion, bone growth stimulators

The Warsaw, Indiana-based orthopaedic device maker is recalling 1,360 of the devices due to a lack of adequate validation and controls to ensure the final products were clean and free from bacteria and chemical residue.

By Susan Kelly • Nov. 28, 2018

Teva launches EpiPen generic at same price as Mylan's version

Teva's entry could be a threat to Mylan's EpiPen, but the limited supply may hamper the commercial impact.

By Suzanne Elvidge • Nov. 28, 2018

Synaptive recalls system over brain damage risk

A defect is preventing surgeons from accurately seeing the locations of their tools in the brain.

By Nick Paul Taylor • Nov. 28, 2018

5 takeaways amid new scrutiny of FDA medical device oversight

A slate of recent agency actions have paralleled a new investigative series on product safety by the International Consortium of Investigative Journalists. Here are five areas that could be impacted.

By David Lim • Nov. 27, 2018

Reprocessor receives FDA clearance for 4 catheters

Innovative Health gained approval to reprocess four catheter brands, two from Medtronic and one each from Johnson & Johnson's Biosense Webster division and Abbott's St. Jude Medical.

By Susan Kelly • Nov. 27, 2018

Pacing leads recalled for potential connector separation

Germany's Oscor is recalling the TB Temporary Bipolar Pacing Leads because the devices could become separated from the external pulse generator.

By Susan Kelly • Nov. 27, 2018

FDA approves autoinjector version of Genentech's Actemra

The Roche unit is pitching the device as a convenient self-administration option for some users of its blockbuster drug.

By Nick Paul Taylor • Nov. 27, 2018

FDA pitches boosting 510(k) scrutiny, asks Congress for help

The agency wants to move away from device maker reliance on 510(k) predicate devices older than 10 years and gain new authority to quickly impose special controls.

By David Lim • Nov. 26, 2018

Medtronic buys nutrition data startup for diabetes care

Nutrino Health’s services include artificial intelligence tools for personalized analysis of how nutritional intake will affect a person's health.

By Susan Kelly • Nov. 26, 2018