FDA clears duodenoscope add-on device aimed at reducing infection

GI Scientific CEO Scott Miller, who formerly held strategy roles at Covidien and Edwards Lifesciences, told MedTech Dive that study data on the device's efficacy will be published in the coming weeks. 

By Maria Rachal • Oct. 25, 2019

Fresenius gets breakthrough tag for clot-preventing dialysis device

The dialysis services giant is testing a system that features a polymer designed to cut the risk of blood clotting without the use of medication.

By Nick Paul Taylor • Oct. 25, 2019

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

Baxter accounting investigation clouds Q3 results

The medtech's stock fell more than 10% Thursday morning on news of misstatements related to foreign exchange transactions that may require amendments to its last five years of financial results.

By Maria Rachal • Updated Oct. 25, 2019

TAVR momentum lifts Edwards' Q3 results, beating estimates

CEO Mike Mussallem predicted brisk growth in procedures would moderate to a low-double-digit pace next year, an estimate analysts called conservative.

By Susan Kelly • Oct. 24, 2019

Device to ID obstructions in post-PCI patients wins breakthrough status

Swiss startup CorFlow Therapeutics created the device to both assess and treat microvascular obstruction in patients after percutaneous coronary intervention.

By Nick Paul Taylor • Oct. 24, 2019

J&J reports rising success rate in robotic surgery clinical trial

The study is assessing diagnostic abilities of the Monarch robotic surgery platform, which Johnson & Johnson gained in the $3.4 billion acquisition of Auris Health.

By Nick Paul Taylor • Oct. 24, 2019

FDA pitches black box warning for breast implants

The agency said it heard "loud and clear" worries of patients who testified at an advisory panel regarding a potential link between certain implants and a form of lymphoma, as well as other adverse events.

By Kim Dixon • Oct. 23, 2019

Emerging markets boost Boston Scientific's Q3 beat

Execs said Wednesday they anticipate FDA's panel meeting next month on duodenoscope safety will increase momentum for its forthcoming single-use version of the device.

By Dana Elfin • Oct. 23, 2019

Device to halt knee implant infections gets breakthrough tag

Garwood Medical Devices is looking to raise $3 million in Series B funding by the end of this year.

By Nick Paul Taylor • Oct. 23, 2019

Baird dentist poll suggests stagnant demand for devices

A drop in patient volumes led analysts to predict businesses such as Align Technology and Dentsply may struggle to beat expectations in the near term. 

By Nick Paul Taylor • Oct. 23, 2019

FDA expands MDIC quality pilot to non-compliant manufacturers

A $2.8 million funding award from the agency aims to extend a program used by big players like Medtronic, Abbott and Boston Scientific to those not yet up to snuff on regulatory compliance.

By Susan Kelly • Oct. 22, 2019

Merged GTX medical seeks broader footprint in spinal cord stim market

GTX hopes to start clinical studies of an implantable spinal cord stimulation system during 2021, CEO Sjaak Decker told MedTech Dive.

By Dana Elfin • Updated Oct. 22, 2019

Canon gets FDA nod for AI tech to enhance CT images

Rising use of CT scans, which expose patients to far more radiation than X-rays, has intensified focus on the risks of the imaging technique, particularly in the pediatric population. 

By Nick Paul Taylor • Oct. 22, 2019

Sleep apnea testing shifts to the home, survey suggests

Use of home-based testing has more than doubled in the past five years as more sleep centers offer the option, which analysts expect will benefit ResMed.

By Susan Kelly • Oct. 21, 2019

Smith & Nephew taps new CEO with diagnostics, orthopaedics resume

Namal Nawana led the medtech for just 18 months, but reportedly clashed with the board over pay. Smith & Nephew's stock was down nearly 10% Monday.

By Dana Elfin • Oct. 21, 2019

TAVR vet in at Medtronic diabetes unit amid shakeup

Cardiac and Vascular Group veteran Sean Salmon will step in to lead Medtronic Diabetes, which has faced an uptick in market competition from CGM makers Abbott and Dexcom and insulin pump manufacturers Tandem and Insulet.

By Maria Rachal • Oct. 21, 2019

Doctor hit with guilty verdict for reusing contaminated catheters, defrauding Medicare

A California physician submitted approximately $12 million worth of claims to Medicare for the medically unnecessary procedures, pocketing $4.5 million.

By Dana Elfin • Oct. 18, 2019

Leasing da Vinci systems is in style: Intuitive Q3 tops estimates

The results come as potential competitors Transenterix and Titan Medical stumbled in the past week and Medtronic inches forward with its own robotic surgery platform.

By Maria Rachal • Oct. 18, 2019

Sens. Warren, Cassidy press FDA on difference between servicing and remanufacturing

The agency does not require servicers, who face fewer regulatory requirements than remanufacturers, to register ​with FDA.

By David Lim • Oct. 18, 2019

AdvaMed lobbies Trump to repeal medical device tax (again)

The trade organization has successfully delayed the levy for years, but the latest moratorium expires at year's end.

By Nick Paul Taylor • Oct. 18, 2019

TransEnterix seeks 'strategic alternatives' amid robot slump, restructuring

RBC analysts said a sale of the company is the most likely outcome after the medtech engaged J.P. Morgan to explore its options. The company's CFO will depart at the end of the year.  

By Nick Paul Taylor • Oct. 18, 2019

Researchers question safety benefit of robotic colectomies

Despite a sharp rise in robot-assisted colon removal procedures using devices like Intuitive Surgical's da Vinci system, research published in JAMA Surgery found a laparoscopic approach has a comparable rate of complications. 

By Nick Paul Taylor • Oct. 17, 2019

Key committee pitches adding UDIs to payer claim forms, called 'huge step'

If a unique device identifier is captured when a high-risk product is implanted, providers will be able to detect complications more quickly, Joe Drozda, the director of outcomes research at Mercy Health, told MedTech Dive.

By David Lim • Oct. 17, 2019

FDA grants breakthrough status to next-generation PSA test

Cleveland Diagnostics' test aims to reduce the number of patients undergoing unnecessary biopsies by looking at structural changes to the protein tied to cancer mutations.

By Nick Paul Taylor • Oct. 17, 2019

Abbott 'working through a handful of items' with FDA on FreeStyle Libre 2

Third-quarter revenue for the medtech came in at $8.08 billion, slightly below Wall Street expectations, but executives praised the growth of key products FreeStyle Libre, MitraClip and Alinity on its earnings call.

By David Lim • Oct. 16, 2019