Medical Devices: Page 163
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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 -
Explore the Trendlineâž”
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Jacob Bell/MedTech Dive
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 -
FDA finalizes biliary stent guide after Cook, Boston Scientific feedback
The final guidance hews closely to the draft released for consultation last year, despite Cook calling for a variety of changes.
By Nick Paul Taylor • July 26, 2019 -
Healthcare the lone growth driver for 3M in Q2
The unit posted 5.8% sales growth, providing some relief for the beleaguered conglomerate, which expects its $6.7 billion buyout of wound care company Acelity to close in the fourth quarter.
By Nick Paul Taylor • July 26, 2019 -
Baxter predicts pouring $500M into US renal care expansion
Potential increased demand for peritoneal dialysis technologies amid a federal push for at-home kidney care drove optimism, as did rising revenues in the medication delivery business after several quarters of disappointing growth.
By Maria Rachal • July 25, 2019 -
Verb Surgical names CEO to shepherd J&J, Verily digital surgery partnership
The startup tapped medtech vet Kurt Azarbarzin as president and CEO Wednesday. He'll be tasked with leading Verb's digital surgery platform toward commercialization.
By David Lim • July 25, 2019 -
Recalled heart balloon pumps linked to 5 patient deaths
Problems have dogged the products, which shut down while running on battery and had design flaws that allowed fluid to seep into the devices.
By Dana Elfin • July 25, 2019 -
DOJ alleges spine maker paid $7M to surgeons in kickbacks
According to the lawsuit, privately held Life Spine failed to report some of the $7 million it paid to surgeons from 2012 to 2018.
By Nick Paul Taylor • July 25, 2019 -
Varian raises sales outlook after oncology devices fuel growth
Although the company raised its full-year sales outlook, there were financial weak spots, including a slowdown in oncology orders and a big drop in sales in its proton business.
By Nick Paul Taylor • July 25, 2019 -
Edwards discontinues Centera valve, goes all in on Sapien 3 TAVR line
Executives said the company anticipates FDA will approve the transcatheter aortic valve replacement product for patients with low surgical risk during the third quarter.
By David Lim • July 24, 2019 -
Asia, structural heart central to Boston Scientific's second half strategy
Japan is slated to be a key market in the back half of 2019, with orders for drug-eluting stents appearing unaffected by FDA's paclitaxel doubts, and Watchman set to launch in September.
By Maria Rachal • July 24, 2019 -
FDA directly links Allergan Biocell breast implants with cancer risk, prompting recall
"FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women's health," Principal Deputy Commissioner Amy Abernethy wrote Wednesday regarding Allergan's Biocell textured devices.
By Nick Paul Taylor • July 24, 2019 -
Titan Medical warns robotic surgery filing target may slip
The Canadian medtech called the regulatory filing schedule "very tight" and "not completely within [its] control."
By Nick Paul Taylor • July 24, 2019 -
FDA grants first cochlear implant indication for asymmetric hearing loss
Austrian company MED-EL said its Synchrony implants won new indications for both asymmetric hearing loss and single-sided deafness in patients age 5 and older without any required changes to the approved devices.
By Susan Kelly • July 23, 2019 -
Jacob Bell/MedTech Dive
FDA sets final guidance on combo product safety reporting
The agency aims to provide clarity on new recordkeeping rules as more medical products combining devices and drugs are hitting the market.
By Susan Kelly • July 23, 2019 -
HHS-backed treatment for mustard gas injuries gains clearance
The new indication for Argentum Medical's burn and wound dressing came with help from the Biomedical Advanced Research and Development Authority.
By Nick Paul Taylor • July 23, 2019 -
Burst balloons prompt safety alert on Edwards Sapien 3 Ultra valve system
The problem is linked to issues with inflation of the valve-delivery system and follows the company's recent recall of its IntraClude intra-aortic occlusion device due to balloon ruptures.
By Susan Kelly • July 22, 2019 -
Intuitive sees bump to Q2 leasing revenues
Rising da Vinci revenues helped drive the robotic surgery technologies maker to a $1.1 billion quarter, surpassing Wall Street expectations.
By Maria Rachal • July 19, 2019
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