Hologic begins selling 3-in-1 uterine scope

The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.

By Susan Kelly • Dec. 11, 2018

Duodenoscope studies find higher-than-expected contamination rate, FDA says

Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled devices were contaminated with microorganisms including pathogenic strains such as E. coli.

By Nick Paul Taylor • Dec. 11, 2018

Explore the Trendline➔

Top 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

Cybersecurity priorities laid out by key House panel

The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity vulnerabilities with a focus on medical devices in healthcare.

By Susan Kelly • Dec. 10, 2018

FDA clears Contego Medical peripheral angioplasty system

The catheter-based device for use in procedures to treat peripheral artery disease incorporates an adjustable filter to capture blood clots and is intended for high-risk patients.

By Susan Kelly • Dec. 10, 2018

FDA to revisit transvaginal mesh issues at February meeting

The agency said it may consider additional regulatory actions based on public feedback and Feb. 12 advisory panel discussions.

By Susan Kelly • Dec. 10, 2018

UPenn surgeons perform first robot-assisted bilateral breast reconstruction

The physicians used Intuitive's da Vinci system to increase the precision of the minimally-invasive procedure.

By Nick Paul Taylor • Dec. 7, 2018

Device industry 2019 outlook beats hospitals, pharma: Moody's

The credit ratings agency said the sector will benefit from new product innovation and demand from emerging markets, but could face headwinds from rising trade tensions and the reinstatement of the medical device tax in 2020.

By Susan Kelly • Dec. 7, 2018

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

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