BD: FDA says Lutonix paclitaxel balloon not approvable for below the knee

BD is working with FDA to determine what additional data is needed to gain the approval, but it is no longer expected this calendar year, executives said on the company's third quarter earnings call.

By Susan Kelly • Updated Aug. 7, 2019

Zimmer hit with $7.7M in damages in hip implant case

The company has now paid more than $400 million in metal-on-metal hip implant cases but still expects to pay out around $130 million more in relation to lawsuits involving Durom Cup and similar devices sold by its Biomet unit.

By Nick Paul Taylor • Aug. 6, 2019

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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

CMS eases breakthrough device path to reimbursement in final rule

As FDA's Breakthrough Devices Program gains in popularity and designated products reach the market, CMS is preparing to offer another benefit: different standards to achieve coverage.

By Maria Rachal • Aug. 5, 2019

VA software workarounds put patient data at risk: OIG

The watchdog made several recommendations after determining fixes intended to allow medical devices to interface with the Veterans Health Administration's EHR system compromised patients’ personal information.

By Susan Kelly • Aug. 5, 2019

B. Braun gets breakthrough status for paclitaxel-coated balloon catheter

The device will be studied for use in treating patients with coronary artery disease who experience in-stent restenosis and could allow patients to avoid an additional stent implant, the company said.

By Susan Kelly • Aug. 5, 2019

FDA extends comment period for draft guidance on magnetic resonance safety

The recommendations are expected to replace a 2014 document and come amid a rapid rise in the use of MRI-compatible medical devices.

By Susan Kelly • Updated Sept. 3, 2019

Abiomed investors spooked by drop in heart pump adoption

After losing more than 25% of its stock value last week, shares in Abiomed inched up Monday morning on news that CMS will not cut reimbursement in fiscal year 2020 for the primary code covering Impella heart pump procedures.

By Maria Rachal • Updated Aug. 5, 2019

Hill-Rom picks up wearable ventilator maker in $130M deal

The medical equipment and systems company announced it's adding Breathe Technologies to its respiratory care business, part of a unit that contributed to Hill-Rom's 3% quarterly revenue growth reported Friday.

By Maria Rachal • Aug. 2, 2019

US to slap 10% tariffs on $300B in Chinese goods as medtech seeks details

The tariffs are set to take effect on Sept. 1. AdvaMed said it "strongly opposes tariffs by both sides on medical technology products" and is lobbying U.S. trade negotiators.

By Shefali Kapadia • Aug. 2, 2019

Japan to reimburse TransEnterix's robotic surgery system

The decision positions the company to compete with Intuitive Surgical in one of the largest markets for the platforms.

By Nick Paul Taylor • Aug. 2, 2019

Cardiac device complications vary 'substantially' by implanting hospital, study finds

The analysis of 98 hospitals, published this week in the Annals of Internal Medicine, uncovered an up-to-threefold difference in cardiac implant complication rates.

By Nick Paul Taylor • Aug. 1, 2019

Dexcom CGM adoption booms as it looks to 'aggressively' pursue Type 2 market

Coming off another beat-and-raise quarter, the company remains focused on adding users via the pharmacy benefit channel, Medicare population and international markets as a potential iCGM rival from Abbott looms.

By Maria Rachal • Aug. 1, 2019

'Political challenges' drag on Hologic's breast health sales in Latin America

Performance in other parts of Hologic's business like molecular diagnostics counteracted some of those challenges, enabling the company to post above-guidance results for the third quarter.

By Nick Paul Taylor • Aug. 1, 2019

FDA grants breakthrough status to Procyrion's cardiac device

Procyrion's Aortix aims to offer physicians a minimally invasive, lower-risk alternative to left ventricular assist devices when treating patients with acute decompensated heart failure and worsening renal function. 

By Nick Paul Taylor • Aug. 1, 2019

FDA announces fiscal 2020 device user fee rates

The fees, which cover medical device registration, submissions and certain periodic reports, show slight increases from the 2019 rates.

By Susan Kelly • July 31, 2019

Slow spine market growth to persist as insurers push back, UBS survey suggests

The investment bank's survey of spine surgeons indicates Medtronic and Globus Medical may get a boost from their robotic and navigation offerings while Johnson & Johnson is expected to continue to lose market share.

By Susan Kelly • July 31, 2019

Sports medicine drives Q2 growth at Smith & Nephew

Strength in U.S. shoulder repair device sales helped offset declining revenues from arthroscopic enabling technologies.

By Nick Paul Taylor • July 31, 2019

CMS pitches add-on payment for new renal care tech, DME fee adjustments

The agency projects total payments to hospital-based ESRD facilities to rise 1.9% year to year while payments to freestanding renal care facilities like DaVita and Fresenius are set to increase 1.5%.

By David Lim , Maria Rachal • July 30, 2019

Mayo, Boston Scientific deepen ties with medtech accelerator launch

The joint venture, called Motion Medical, is expected to open in Rochester, Minnesota this fall with the purpose of bringing minimally invasive treatments to market for unmet health needs.

By Susan Kelly • July 30, 2019

Humana accuses Abbott of duping it to pay to remove dodgy heart devices

The suit alleges St. Jude, now a part of Abbott, knew about a battery depletion defect in its heart rhythm devices for four years before notifying FDA, and then schemed to have the insurer pay for surgeries to remove patients' implants.

By Susan Kelly • July 30, 2019

ResMed discloses tentative DOJ settlement, sets aside $41.2M

A resolution to a DOJ probe, disclosed during the sleep apnea device maker's fourth quarter earnings call, would settle an investigation into marketing and financing practices related to the company's resupply program.

By Susan Kelly • July 29, 2019

Australia on watch for possible EU notified body shortage

The country's Therapeutic Goods Administration has issued new guidance to aid device makers seeking overseas marketing authorization.

By Susan Kelly • July 29, 2019

New delivery system for sinus stent gains FDA approval

Intersect ENT's line of steroid-releasing stents are the first and only dissolvable sinus implants approved by FDA, according to the company.

By Susan Kelly • July 29, 2019

Stryker says Mako robot driving orthopaedic share gains

The orthopaedics giant said the robotic surgery system is supporting above-market growth in hip and knee implants, but pressure may soon increase as Zimmer Biomet expands the rollout of Rosa Knee.

By Susan Kelly • July 26, 2019

Zimmer Biomet to increase robotics R&D as new CFO takes helm

The company saw its best growth in its knee business in three years during the second quarter, even without contributions from the limited launch of the Rosa Knee system, executives said.

By Maria Rachal • July 26, 2019