Medical Devices: Page 141
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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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Jacob Bell/MedTech Dive
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 -
FDA warns dental X-ray supplier over radiation exposure reporting
The agency said Denterprise International didn't report complaints involving patients accidentally exposed to radiation and asked for a retrospective review of all such incidents.
By Susan Kelly • Oct. 16, 2019 -
CMR launches robot, CEO says European deals coming soon
On the back of a $240 million private financing round, the U.K. medtech is beginning commercial expansion of its modular robotic surgery system in Europe and Asia as it awaits FDA's go-ahead.
By Maria Rachal • Oct. 16, 2019 -
ViewRay bucks payment fears in field dubbed 'not dead' yet
The radiation oncology company received eight new orders for its MRI-guided Linac, easily beating Jefferies' forecast.
By Nick Paul Taylor • Oct. 16, 2019 -
Titan scraps filing plan for robotic surgical system amid cash crunch
The Canadian medtech is abandoning plans to seek FDA clearance to sell its single port system before 2021.
By Nick Paul Taylor • Oct. 16, 2019 -
J&J device business outperforms in China as US pricing pressures persist
Double-digit sales growth in China and a surge in contact lens purchases in Japan helped offset share declines in certain U.S. orthopaedics markets.
By Maria Rachal • Oct. 15, 2019 -
California bill to end excessive dialysis profits becomes law
Fresenius said it's concerned the new law will result in patients only being able to access care at hospitals due to lack of insurance coverage.
By Susan Kelly • Oct. 15, 2019 -
Two weeks from Brexit deadline, UK floats device contingency
A no-deal Brexit would not meet any of MedTech Europe's four priorities.
By Nick Paul Taylor • Oct. 15, 2019 -
Hospitals, manufacturers could donate cybersecurity software under proposed regs
With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.
By David Lim • Oct. 14, 2019 -
Medical software makers get new guidance on MDR, IVDR
The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.
By Dana Elfin • Oct. 14, 2019 -
Abbott deepens Type 2 diabetes play with Omada partnership
While CGMs have been most widely adopted among the Type 1 population, Abbott has worked to show the technology's benefit in the under-penetrated Type 2 market, which accounts for 95% of all Americans living with diabetes.
By Maria Rachal • Oct. 14, 2019 -
FDA pushes back against criticism of third party 510(k) review
The agency deflected suggestions that the plan puts the burden on patients and doctors to figure out which devices are safe.
By Susan Kelly • Oct. 14, 2019 -
GAO finds low uptake of disposable wound care devices
Advocates of the products, sold by companies including Acelity and Smith & Nephew, argue the size and cost make them preferable to durable devices when treating small wounds.
By Nick Paul Taylor • Oct. 11, 2019 -
CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities
The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.
By David Lim • Oct. 11, 2019 -
HHS hesitant to include implantable medical devices in Anti-Kickback safe harbor
The government appears to be considering various methods to exclude device manufacturers from its care coordination safe harbor while allowing digital health technologies used to remotely monitor patients to take advantage of it.
By David Lim • Oct. 10, 2019 -
Jacob Bell/MedTech Dive
Edwards-backed Corvia gets leg up with FDA breakthrough nod
The interatrial shunt device for heart failure patients with preserved or mid-range ejection fraction won benefits under the streamlined review. Edwards Lifesciences owns the exclusive right to acquire the company.
By Maria Rachal • Oct. 10, 2019
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