Medtronic thoracic stent graft system approved in Japan

The device addresses common attributes and conditions in the Japanese patient population such as greater aortic fragility, smaller anatomy and aortic wall stress, the director of the Japanese Society for Vascular Surgery said.

By Nick Paul Taylor • Nov. 1, 2019

Teleflex raises outlook despite taking $8.7M hit tied to sterilization facility closure

CEO Liam Kelly told analysts its sterilization provider has yet to get a "clear line of sight as to when that facility may be reactivated."

By Nick Paul Taylor • Nov. 1, 2019

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority

FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.

By David Lim • Oct. 31, 2019

Abiomed targets 'TAVR-like' adoption for protected PCI

Investors appear optimistic about the company's strategy, with its stock up more than 10% in morning trading despite the specter​ of FDA's questions about survival outcomes with Abiomed's right heart pump in February.

By Maria Rachal • Oct. 31, 2019

Smith & Nephew ups outlook a day before new CEO takes helm

Sales of sports medicine joint repair products rose 12.2%, the biggest jump yet in a year that's seen growth of at least 11% each quarter. 

By Nick Paul Taylor • Oct. 31, 2019

FDA puts J&J's Ethicon surgical stapler recall in top risk category

Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market.

By Nick Paul Taylor • Oct. 31, 2019

Mako momentum lifts Stryker results amid core spine drag

Despite new competition from Zimmer Biomet's total knee application for Rosa, one Stryker exec called pricing for the Mako joint replacement robot "extremely stable" as the company expects 2019 organic sales growth near 8%.​

By Maria Rachal • Oct. 30, 2019

Medtronic developing fully implanted LVAD with FDA breakthrough support

Medtronic's HeartWare left ventricular assist device to treat advanced heart failure has lost ground to Abbott's HeartMate system, but its forthcoming tech could be an alternative that does not rely on an external power source.

By Susan Kelly • Oct. 30, 2019

It's official: EC confirms 2-year Eudamed delay

The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects. 

By Dana Elfin • Oct. 30, 2019

Surmodics gets breakthrough tag for critical limb ischemia device

The Minnesota medtech, which is also in the midst of testing a drug-coated balloon licensed by Abbott, now has a boost from FDA in bringing to market a sirolimus-delivering device designed to prevent amputation and death.

By Nick Paul Taylor • Oct. 30, 2019

FDA again warns of leak risk with Endologix AAA grafts

Regulators are concerned about new data pointing to a roughly 1 in 10 probability of mortality related to blood leaking into the aneurysm.

By Susan Kelly • Oct. 29, 2019

Sanford agrees to $20M settlement to resolve kickback allegations

The case centered on implants sold by a physician-owned distributorship and allegations a Sanford Health neurosurgeon used those devices to perform medically unnecessary procedures.

By Nick Paul Taylor • Oct. 29, 2019

A UK challenger to da Vinci seeks to chip away at robotic surgery 'monopoly'

Having filed a submission with FDA and won a CE mark, CMR Surgical has a head start on household names like Medtronic and J&J, all of which are seeking a slice of the robot-assisted minimally invasive surgery market.

By Maria Rachal • Oct. 28, 2019

Abiomed says right-heart pump protocol boosts survival in postmarket data

The medtech is aiming to reverse slowed demand by demonstrating that a higher patient mortality rate in postmarket results for its right-heart system, compared to premarket data, is due to sicker patients receiving the device.

By Susan Kelly • Oct. 28, 2019

Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body

BSI joins Dekra Germany as designated under the In Vitro Diagnostic Regulation ahead of its 2022 implementation date.

By Dana Elfin • Oct. 28, 2019

BD to suspend sterilization plant after FDA warning on device shortages

BD agreed Monday to temporarily halt operations at a Georgia ethylene oxide medical device sterilization facility, allowing regulators to assess surrounding air quality. The medtech doesn't anticipate disruptions to product availability.

By Maria Rachal • Updated Oct. 28, 2019

Deal wave expected as private equity eyes orthopaedic practices

The business of replacing hips and knees is a lucrative area for investors as joint replacements are set to rise and care migrates to outpatient settings.

By Samantha Liss • Oct. 25, 2019

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

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