5 key parts of the FDA Medical Device Safety Action Plan

The ambitious proposal focuses on a total lifecycle approach to device safety.

By Meg Bryant • July 23, 2018

Bayer to stop selling Essure birth control implant in US

The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.

By Susan Kelly • July 23, 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

Tendyne investors sue Abbott over lost milestone payment

After the success of transcatheter aortic valve replacement therapy, device companies are now focusing efforts on minimally invasive procedures to replace the mitral valve. 

By Susan Kelly • July 23, 2018

Intuitive Surgical profit up on strong da Vinci robot sales

The company has long dominated the market, but bigger players like Medtronic and Verb Surgical are now developing their own surgical robots.

By Susan Kelly • July 20, 2018

Boston Scientific to buy Claret Medical for $220M

The device giant was impressed by the effectiveness of Claret's device in reducing the incidence of strokes during TAVR procedures and the opportunity for other future uses.

By David Lim • July 20, 2018

US, China power GE Healthcare to double-digit profit rise

The results validate the strength of the unit ahead its planned spinoff.

By Nick Paul Taylor • July 20, 2018

Hikma ramping up injectable opioid output for US hospitals

The American Medical Association declared drug shortages to be a national public health emergency last month, and the stream of opioids available to providers has continued to dry up.

By Rebecca Pifer • July 19, 2018

Industry seeks clarity on latest FDA Pre-Cert working model

A software coalition questioned the agency's statutory authority to run a pilot test in 2019.

By David Lim • July 19, 2018

Abbott beats expectations as sales of diabetes device soar

Glucose monitor FreeStyle Libre drove 40% growth at the diabetes unit, the company's best performer.

By Nick Paul Taylor • July 19, 2018

FDA reiterates concern about off-label use of bile-duct stents

In 2016, Abbott won a whistleblower lawsuit by a former sales representative who accused the company of off-label marketing of bile-duct stents to treat peripheral artery disease.

By Susan Kelly • July 18, 2018

Calls to revamp physician self-referral law grow louder

Device makers, lab, imaging and hospital companies all back changes to the Stark law, arguing it impedes the move toward alternative payment and value-based care.

By Susan Kelly • July 18, 2018

Ra files for $86M IPO to commercialize vascular disease device

The laser-based device is competing against products from Medtronic and Boston Scientific.

By Nick Paul Taylor • July 18, 2018

FDA approves Stryker flow diverter, creating competition for Medtronic

The device gives surgeons another way to treat unruptured intracranial aneurysms.

By Nick Paul Taylor • July 18, 2018

It's time for medtech to turn digital

Here's how digital health solutions can help medtech companies transform how they go to market.

By Pete Masloski • July 17, 2018

Device industry lobbies FDA on combo product classification

AdvaMed argues the agency too often concludes a product’s primary mode of action is that of a drug or biologic rather than a device.

By Susan Kelly • July 17, 2018

J&J says medical device sales improve in second quarter

CEO Alex Gorsky told investors on a conference call the company is "very interested in value creating inorganic growth opportunities in medical devices."

By Susan Kelly • July 17, 2018

Cannabis-based drugs and devices: A winning combo?

Tetra Bio-Pharma and Storz & Bickel will collaborate to bring a marijuana-based drug, inhaled in an herbal vaporizer, to fibromyalgia patients in Canada.

By Barbara Boughton • July 17, 2018

Quest study contends value-based care adoption has slowed

The survey found that 57% of health plan executives believe physicians do not have the necessary tools to succeed in a value-based system, up from 45% last year.

By David Lim • July 17, 2018

Biogen looking to expand into medtech: report

The biotech is considering how imaging and data technologies could bolster its position in neurology, according to the Israeli paper Globes. 

By Lisa LaMotta • July 16, 2018

Abbott device to repair leaky heart valves approved

Artificial heart valve pioneer Edwards LifeSciences is developing treatments for mitral regurgitation that would compete with Abbott's MitraClip.

By Susan Kelly • July 16, 2018

CMS targets data gaps in setting lab payments

The American Clinical Laboratory Association said it "will urge Congress as well as CMS to address significant shortfalls in the data collection process that jeopardize care for the most vulnerable seniors."

By Susan Kelly • July 16, 2018

Transition clock ticking on new EU device regs

"It's a problem because how do you comply with a new standard when you don't know what the standard is?" said AdvaMed's Joe Gatewood.

By Meg Bryant • July 16, 2018

More insurers using outcomes-based deals with drug, device companies

Heart, infectious diseases and oncology are the top three therapeutic areas where the contracts are used, according to an Avalere survey.

By Meg Bryant • July 13, 2018

Medtronic gets expanded FDA label for cardiac pacing lead

The label expansion covers use of the device in His bundle pacing.

By Nick Paul Taylor • July 13, 2018

Medtech spared as US unveils tariffs on imports worth $200B

Most medical devices will not be affected by the proposed 10% levy. 

By Nick Paul Taylor • July 13, 2018