Medical Devices: Page 162
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Hill-Rom to sell surgical consumables unit for $170M
The transaction will free Hill-Rom​ of a stagnant business and its 500 employees, while giving it more cash to spend on acquisitions.
By Nick Paul Taylor • July 11, 2019 -
Trump executive order seeks to overhaul US kidney care
The plan aims, in part, to increase the number of organs available for transplant by encouraging the development of artificial and wearable kidneys and modernizing the organ recovery and transplantation system.
By Rebecca Pifer Parduhn • Updated July 10, 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 -
USTR exempts some medical devices from 25% China tariffs
More decisions on pending requests for exemption will be made on a periodic basis, according to the U.S. Trade Representative.
By David Lim • July 10, 2019 -
Yujin Kim/MedTech Dive
Amazon's momentum in medical supply chain slowing, poll finds
A UBS survey of hospital purchasing managers found providers are allocating purchases of surgical tools, orthopaedic and cardiology implants, and other medical supplies to Amazon at a lower rate this year compared to 2018.
By Rebecca Pifer Parduhn • July 10, 2019 -
Edwards poised for a Q2 TAVR rebound, analysts predict
Jefferies tracked hospital purchasing data and found U.S. transcatheter aortic valve replacement procedures with Edwards' devices likely accelerated in the second quarter, despite Boston Scientific adding new competition to the mix.
By Susan Kelly • July 10, 2019 -
Hospital purchasers call 3D mammography, robots and TAVR investment priorities
UBS estimates stable growth of 3.6% in hospital capital budgets based on data collected from managers surveyed.
By David Lim • July 9, 2019 -
The 10 biggest medtech stories of Q2
Key storylines — like escalating tariffs between the U.S. and China, FDA's evolving position on paclitaxel devices, and the uncertain capacity of Europe's notified bodies — will unfold in the second half of the year.
By Maria Rachal • July 9, 2019 -
Medtronic HVAD shows low stroke risk in study of thoracotomy approach
The clinical data could help Medtronic reverse market share losses to Abbott, which makes a competing left ventricular assist device for patients suffering from advanced heart failure.
By Susan Kelly • July 9, 2019 -
Feds warn of cyber vulnerability in hospital anesthesia machines
The issue, found in GE's Aestiva and Aespire devices, could allow an attacker to impair respirator functionality by silencing alarms, altering time and date records, and changing the composition of aspirated gases.
By Susan Kelly • July 9, 2019 -
UnitedHealth backs Inspire Medical's sleep apnea implant
The massive private payer deemed the Minnesota medtech's neurostimulation system medically necessary in patients with obstructive sleep apnea who have already tried CPAP therapy.
By Maria Rachal • July 9, 2019 -
UL to close UK medical device notified body operation
The notified body is stepping back from the U.K. device sector altogether and will limit its in vitro diagnostic services in response to the risk of a no-deal Brexit.
By Nick Paul Taylor • July 9, 2019 -
Sens. Warren, Murray probe FDA's 'alarming' progressive device approval idea
The Democrats gave the agency until July 8 to respond to their questions on a recent budget proposal that seeks to grant FDA a two-step approval process for medical devices for life-threatening conditions.
By David Lim • July 8, 2019 -
Edwards issues safety notice for Centera valve after reports of injury, death
The company said difficulty manipulating the device around the aortic arch has resulted in reports of vascular injury, and recommended use of a stiffer guide wire or an alternate treatment for certain types of anatomies.
By Susan Kelly • July 8, 2019 -
Insulin pen smart cap maker in talks to supply Sanofi
French medical device maker Biocorp's Internet-connected cap is designed to work with a conventional insulin pen and can automatically transmit dosage data to a smartphone app.
By Susan Kelly • July 8, 2019 -
Spanish agency steps up to become an MDR notified body
The decision comes as some in the sector have expressed concerns about whether there will be enough notified bodies to adequately support the transition to the EU's new medical device rules.
By Susan Kelly • July 8, 2019 -
Invacare lays off 75 as turnaround effort drags on
The medical equipment manufacturer is making cuts in Europe and North America, adding to the steady flow in both regions in recent years.
By Nick Paul Taylor • July 4, 2019 -
Doctors significantly over-allocated times to perform joint replacements, study shows
Time periods estimated to perform medical procedures, known as relative value units, are crucial for determining how much surgeons and other doctors are paid for their work under the Medicare Physician Fee Schedule.
By Ron Shinkman • July 3, 2019 -
Wright Medical shares tumble amid report of Cartiva slowdown
Surgeons are implanting fewer of the devices to treat arthritis of the big toe as more patients report dissatisfaction with post-operative pain, degree of motion or device slippage, RBC Capital Markets analysts said in a research note.
By Susan Kelly • July 3, 2019 -
FDA patient advisory meeting set to tackle cybersecurity in devices
The September meeting will partly focus on how healthcare providers should best communicate cybersecurity risks to medical device users.
By Susan Kelly • July 3, 2019 -
CMS extends ambulatory blood pressure monitoring coverage
In a change, patients with masked hypertension will be eligible for testing.
By Nick Paul Taylor • July 3, 2019 -
International Trade Commission probes Intuitive imports following J&J complaint
The ITC began the investigation after J&J's Ethicon argued certain Intuitive stapler cartridges infringe its patents.
By Nick Paul Taylor • July 3, 2019 -
Varian, Boston Scientific seal the deal on beads business transfer
Varian Medical Systems said Wednesday it completed the $90 million purchase of Boston Scientific's drug-loadable microspheres and bland embolic beads, a transaction key to Boston Scientific's buyout of BTG finalized Monday.
By Maria Rachal • Updated Aug. 21, 2019 -
FDA finalizes rule on requesting review of CDRH decisions
The agency declined an AdvaMed request for additional time to seek supervisory review after a company receives details of a significant decision.
By David Lim • July 2, 2019 -
Ruptured Edwards balloons linked to 3 patient deaths
FDA revealed there have been 22 complaints related to rupture or puncture of an intra-aortic occlusion device, which can put patients at risk of complications like embolism, neurological damage and stroke.
By Nick Paul Taylor • July 2, 2019 -
Military-focused abdominal trauma foam earns FDA breakthrough status
The agency awarded the designation to Critical Innovations, a company developing technologies for individuals injured in combat.
By Susan Kelly • July 1, 2019
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