CDHR extends staff training program into 2019

The Experiential Learning Program provides ongoing training for FDA staff about the device development cycle.

By Rebecca Pifer • July 30, 2018

Protecting patients from emergent cybersecurity threats is the shared responsibility of the entire healthcare supply chain

Breaches in medical device cybersecurity pose a significant threat to hospitals and the patients they serve.

By Todd Ebert & Curt Miler • July 27, 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

ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups

"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.

By David Lim • July 27, 2018

FDA gives draft guidance on atherectomy device submissions

The advice is intended to help manufacturers develop a risk analysis and performance testing strategy for devices used to remove plaque from diseased peripheral arteries. 

By Susan Kelly • July 27, 2018

Baxter boosts 2018 outlook but IV bag supply still under pressure

"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO ​José Almeida told investors.

By David Lim • July 26, 2018

NIH teams with Google Cloud for new biomedical research project

The agency is partnering with Google, which appointed former Cleveland Clinic CEO Toby Cosgrove to advise Google Cloud healthcare initiatives.

By Meg Bryant • July 25, 2018

Roche's rice-sized Lucentis implant headed for advanced testing

Phase 2 data showed the majority of wet AMD patients implanted with the device went six months before needing a refill of the drug.

By Jacob Bell • July 25, 2018

Stryker says Q2 tops goals, will stick to M&A playbook

The device maker boasted of strong demand for its robot for knee surgery but said its spine business remained "challenged."

By Susan Kelly • July 25, 2018

Boston Scientific beats Q2 targets as neuromodulation devices gain share

Demand for the WaveWriter spinal cord stimulator fueled the results. Cardiovascular was the weakest performer.

By Nick Paul Taylor • July 25, 2018

Endomagnetics' Sentimag System scores approval from FDA

The system, which helps guide lymph node biopsies for breast cancer patients undergoing mastectomy, utilizes magnetic rather than radioactive materials.

By David Lim • July 25, 2018

House repeals medical device tax, Senate path muddied

The device industry has successfully put off the tax, one of several imposed on industry in the Affordable Care Act, for years.

By David Lim • Updated July 24, 2018

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

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