Medical Devices: Page 159
-
FDA grants breakthrough status to Perfuze stroke device
The startup is attempting to enter a field fought over by Johnson & Johnson, Medtronic and Stryker.
By Nick Paul Taylor • Aug. 8, 2019 -
TransEnterix admits its robotics system falls short for docs amid sales slump
Senhance has failed to consistently live up to high expectations of physicians used to Intuitive Surgical's devices, TransEnterix execs said. Shares plunged more than 25% on Thursday.
By Nick Paul Taylor • Aug. 8, 2019 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew 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 -
FDA to update paclitaxel device labels with mortality signal warning
The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.
By David Lim • Updated Aug. 8, 2019 -
Insulin pump makers post double digit gains amid record patient additions
Shares in Insulet were up more than 18% Tuesday morning after the company posted 43% revenue growth as more people transition from multiple daily injections. Rival Tandem last week reported a 290% rise in pump shipments.
By Maria Rachal • Aug. 6, 2019 -
Abbott recommends removal of certain ICDs due to exposed wires
FDA said 108 of the devices are recalled in the United States, of which 31 are implanted in patients.
By Susan Kelly • Aug. 6, 2019 -
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 -
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 -
Jacob Bell/MedTech Dive
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 -
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 -
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 -
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
Previous
