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

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

Vectura asthma drug-device combo fails in Phase 3 study

As a result, the pharma will abandon VR475 but carry on with another candidate and three early-stage nebulization programs.

By Andrew Dunn • Nov. 26, 2018

FDA device inspections hit high amid overseas oversight push

The agency conducted 2,952 inspections of medical device manufacturers last year, an increase of 46% over 2007.

By Nick Paul Taylor • Nov. 22, 2018

CMS gives mixed ruling on LivaNova depression device

A big market opportunity awaits the U.K. device maker if Medicare moves to cover the vagus nerve stimulation device for hard-to-treat depression after a required clinical trial.

By Maria Rachal • Nov. 21, 2018

FDA details ramp-up of postmarket device oversight

The agency laid out plans to increase postmarket surveillance of medical devices and previewed details coming next week on how it expects to modernize premarket reviews, especially the 510(k) process.

By Susan Kelly • Nov. 21, 2018

Scientists unveil first 3D images from new whole-body scanner

The scanner combines positron emission tomography and X-ray computed tomography to produce movies that can track drugs as they move through the body.

By Susan Kelly • Nov. 21, 2018

Sandoz and Pear begin selling digital substance use treatment

The FDA called it the first mobile medical app to treat substance use disorders. Pear raised $50 million to fund the commercialization before deciding to pass responsibility for the introduction onto Sandoz.

By Nick Paul Taylor • Nov. 21, 2018

Medtronic posts strong Q2 on diabetes, pain management

Growth in the quarter was led by a 26.2% jump in diabetes group revenue, powered in part by demand for the MiniMed 670G hybrid closed loop insulin pump system in the U.S. market.

By Susan Kelly • Updated Nov. 20, 2018

New Philips ventilator combines two modes in one device

Royal Philips received CE mark approval for a device that allows clinicians to quickly alternate between noninvasive ventilation and high flow therapy used to wean respiratory patients from NIV.

By Susan Kelly • Nov. 20, 2018

FDA plan would ease regulations for prescription drug apps

The agency is seeking public comment on a proposed regulatory framework that would treat most prescription drug apps, including dose calculators, symptom trackers and medication reminders, as promotional labeling.

By Susan Kelly • Nov. 20, 2018

Boston Scientific snags BTG for $4.2B

The Federal Trade Commission cleared the merger and the deal is now slated to take effect Aug. 19, Boston Scientific said in an SEC filing Wednesday, a month after it addressed antitrust concerns by divesting its beads business.

By Nick Paul Taylor • Updated Aug. 7, 2019

Colfax strikes $3.15B buyout of orthopaedics player DJO

The acquisition will move the industrial technology conglomerate into a new market: medical devices.

By Nick Paul Taylor • Nov. 20, 2018

Edwards Lifesciences gets CE mark for advanced heart valve

The company's latest transcatheter aortic valve includes a new delivery system and sheath to help the surgeon place the device in the heart more efficiently and an outer skirt designed to stop leakage.

By Susan Kelly • Nov. 19, 2018

Medtronic aneurysm repair device proves durable in complex cases

Three-year registry data showed a high percentage of patients were free from aneurysm-related mortality after receiving the Heli-FX EndoAnchor system.

By Susan Kelly • Nov. 19, 2018

Boston Scientific to spend over $200M in restructuring

The Marlborough, Massachusetts-based company anticipates "limited" headcount reductions and some employee attrition from a global restructuring plan set to run from 2019 to 2021.

By Susan Kelly • Nov. 19, 2018

Abbott seeks clearer security standards as feds increase cyber risk focus

President Trump is expected to sign legislation Friday creating a new cyber agency within the Department of Homeland Security. 

By Maria Rachal • Nov. 16, 2018

GE Healthcare recalls nuclear medicine imaging systems

The diagnostic imaging system giant is recalling 996 of the machines after an incident in which a part of the device fell onto the detector below it.

By Susan Kelly • Nov. 16, 2018

With technology foundation solidified, Johnson & Johnson's attention turns to what's next

Though advanced in its technical capabilities, J&J has weighed the merits of build versus buy when it comes technologies like AI.

By Naomi Eide • Nov. 16, 2018

AdvaMed makes lame duck push for medical device tax repeal

Given the impending Democratic control of the House, the trade group's CEO Scott Whitaker said "the chances are not as great next year" for permanent repeal if the industry does not garner a victory.

By David Lim • Nov. 15, 2018

FDA sounds alarm about off-label drug use in pain pumps

The agency wants physicians to stick to approved drugs to reduce the risk of device failure in the pumps, which include those sold by Medtronic and J&J.

By Nick Paul Taylor • Nov. 15, 2018

ResMed wraps up $750M MatrixCare buyout in SaaS push

The sleep apnea company has spent almost $1.7 billion on software businesses in recent years.

By Nick Paul Taylor • Nov. 15, 2018

US Vascular gets FDA warning letter for long-running problems

Most of the points raised in the regulatory notice date back to a 2016 inspection.

By Nick Paul Taylor • Nov. 15, 2018

Millennial to menopausal, women's health is fertile space for startups

Early-stage investors have increased support for female-specific devices and direct-to-consumer diagnostics in the last five years, as the women’s health market is poised to reach $50 billion globally by 2025.

By Maria Rachal • Nov. 14, 2018

Atlantic gains FDA nod for wearable incontinence device

The device delivers electrical stimulation to pelvic floor muscles to prevent the leakage of urine.

By Nick Paul Taylor • Nov. 14, 2018