FDA rolls out plan to reduce third party 510(k) re-reviews

Commissioner Scott Gottlieb said outsourcing review of low-risk devices can enable FDA to focus more resources on high-risk and more complex devices.

By David Lim • Sept. 14, 2018

AngioDynamics to buy RadiaDyne for radiotherapy devices

RadiaDyne thinks AngioDynamics' commercial infrastructure will help it to grow sales beyond the $6 million achieved over the past 12 months.  

By Nick Paul Taylor • Sept. 14, 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

FDA delays Inbrija drug-device combo

Regulators need more time to assess the biotech's Parkinson's drug-device combination, adding another layer of complexity to manufacturing and approval processes.

By Jacob Bell • Sept. 13, 2018

J&J buys EIT for 3D-printed titanium spinal implants

The devices are designed to increase the number of surgeries that are successful the first time.

By Nick Paul Taylor • Sept. 13, 2018

New Apple Watch adds FDA-cleared ECG application

Agency officials touted the clearance as heralding a new age of digital health. Still, risks include false positives and negatives, which could lead to unneeded procedures or misdiagnosis.

By David Lim • Sept. 12, 2018

FDA advised to step up device cybersecurity checks premarket

In response to the watchdog report, FDA said it is already working on implementing the recommendations.

By Susan Kelly • Sept. 12, 2018

Medtronic plants hit with FDA warning letters

The notices relate to two facilities that made recalled implantable cardioverter-defibrillators.

By Nick Paul Taylor • Sept. 12, 2018

Cook resolves FDA warning letter that slammed quality processes

The close-out letter follows four years of work to improve quality management.

By Nick Paul Taylor • Sept. 12, 2018

Medtronic to study one month of DAPT in high-bleeding-risk patients

The study will look at whether a shortened dual antiplatelet therapy regimen is enough to minimize stent thrombosis and other complications in patients.

By Susan Kelly • Sept. 11, 2018

AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test

The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.

By David Lim • Sept. 11, 2018

Stryker buys surgical lighting company for $190M

Photonics and intracavity lighting company Invuity is the latest acquisition in Stryker's ongoing purchasing spree.

By Rebecca Pifer • Sept. 11, 2018

FDA raises concerns about feeding tube misconnections

The agency is recommending hospitals and clinicians use devices with connectors that meet International Organization for Standardization requirements.

By Susan Kelly • Sept. 10, 2018

Becton Dickinson sells bioprocessing business to Thermo Fisher

Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.

By Susan Kelly • Sept. 10, 2018

Bundled payment model cuts joint replacement costs in study

The evaluation of the Comprehensive Care for Joint Replacement program, prepared for CMS, found the drop in costs was primarily due to reduced use of post-acute care institutions.

By Susan Kelly • Sept. 10, 2018

FDA clears new version of Baxter bone graft substitute

Johnson & Johnson's DePuy Synthes unit, Medtronic and Stryker make competing synthetic bone grafts. 

By Susan Kelly • Sept. 7, 2018

Livongo adds continuous glucose data via Abbott's FreeStyle Libre

Gathering continuous glucose data is intended to help diabetes patients and their doctors personalize treatment and improve decisions about care.

By Susan Kelly • Sept. 7, 2018

As EpiPen struggles, Walgreens, Kaleo ink Auvi-Q partnership

Auvi-Q will now be offered at Walgreens' roughly 9,800 locations at no cost for commercially insured patients eligible for Kaleo's patient support programs.

By Jacob Bell • Sept. 7, 2018

BTG acquires Irish device maker Novate Medical

The $20 million cash deal could reach $150 million if certain business milestones are met.

By David Lim • Sept. 7, 2018

Boston Scientific inks $600M Augmenix buyout

The focus of the deal is a device to reduce the side effects of prostate cancer radiotherapy.

By Nick Paul Taylor • Sept. 7, 2018

Life science CEOs see future in technology, disruption

A KPMG survey also showed that cybersecurity remains a major pain point, with 33% of executives calling it the top risk to their organization's growth.

By Meg Bryant • Sept. 6, 2018

MRI-compatible cardiac rhythm implants cost hospitals $400M a year: report

The analysis questions the value of paying extra for premium cardiac rhythm management devices.

By Nick Paul Taylor • Sept. 6, 2018

Watchdog slams Veterans Health Administration on device sterility

GAO investigators found failings in the oversight of reusable medical equipment cleaning.

By Nick Paul Taylor • Sept. 6, 2018

Gottlieb: UnitedHealth, CareFirst sign onto FDA pilot aiming to speed device coverage

The FDA chief also outlined new programs including "QUiK Review" aimed at cutting review times for low-risk 510(k) submissions "by as much as 30%."

By David Lim • Sept. 5, 2018

Developing afib after valve implant raises risks, study finds

Just a third of patients who developed atrial fibrillation after a transcatheter aortic valve replacement procedure got oral anticoagulation medication at discharge, according to a Duke University study.

By Susan Kelly • Sept. 5, 2018

Aetna to cover Abbott's non-opioid pain implant Proclaim

The decision opens up a potential market of 22 million people for the neurostimulation device.

By Nick Paul Taylor • Sept. 5, 2018