Medical Devices: Page 175
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Medtronic begins study of ICD with leads outside the heart
The device, called the Extravascular Implantable Cardioverter Defibrillator, will provide the same therapies as traditional transvenous ICDs.
By Susan Kelly • Aug. 10, 2018 -
Boston Scientific inks Veniti takeover to access untapped stent market
The $160 million buy moves the company into the nascent venous stent sector.
By Nick Paul Taylor • Aug. 9, 2018 -
Explore the Trendline➔
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TrendlineMedical 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 -
Senseonics rolls out 90-day continuous glucose monitoring
The Eversense system will compete with Abbott's FreeStyle Libre monitor, which last month cleared FDA approval.
By Susan Kelly • Aug. 8, 2018 -
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Regs, patient perceptions threaten to throttle neuromodulation growth
Analysts think electrical stimulation devices may struggle to fulfill their commercial potential, challenging the perception that they will soon address a range of unmet neurological medical needs.
By Nick Paul Taylor • Aug. 8, 2018 -
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Varian acquires maker of patient monitoring system
The radiation therapy company said the buy expands its motion-management portfolio, part of its cancer care strategy.
By Susan Kelly • Aug. 7, 2018 -
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CMS' Verma stands firm on 2015 EHR deadline, move to open APIs
Meanwhile, the coalition Health IT Now sent a letter to ONC chiding the government for failing to implement information blocking provisions of the 21st Century Cures Act.
By Meg Bryant • Aug. 7, 2018 -
UK regulators reassure medtech sector about Brexit impact
The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.
By Nick Paul Taylor • Aug. 7, 2018 -
Cardinal Health posts Q4 loss as Cordis struggles
The drug and medical product distribution giant said it is working to turn around the Cordis business under a new management team.
By Susan Kelly • Aug. 6, 2018 -
Abbott device to treat Parkinson's now MRI-compatible
Medtronic's deep brain stimulation system was approved in 2002 to treat advanced Parkinson's disease. Abbott acquired its system through its purchase of St. Jude.
By Susan Kelly • Aug. 3, 2018 -
CMS clears payment for Boston Scientific's newly bought Sentinel
The ruling by the agency was a reversal from an earlier draft and came the day BSX closed its buy of Claret Medical, which makes the device.
By Kerry Dooley Young • Aug. 3, 2018 -
BD raises 2018 targets after broad-based Q3 growth
The company has maintained momentum as it spends the year integrating the buys of CareFusion and C. R. Bard.
By Nick Paul Taylor • Aug. 3, 2018 -
Baxter gets CE mark for Evo IQ smart infusion pump
The clearance marks the start of a series of planned regulatory submissions for the device, which will potentially compete with those made by rivals B. Braun and BD.
By Nick Paul Taylor • Aug. 2, 2018 -
FDA approves Medtronic implant for rare form of hypertension
United Therapeutics will lead commercial promotion of the system, which delivers the drug Remodulin.
By Susan Kelly • Aug. 1, 2018 -
CSI, Aerolase partner on laser atherectomy device
St. Paul, Minnesota-based CSI competes in the market against much bigger players including Medtronic, Boston Scientific and Phillips.
By Susan Kelly • Aug. 1, 2018 -
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Deep DiveIndustry balks at FDA's cybersecurity plans
"We already know that FDA will reject premarket submissions if they do not follow the cybersecurity guidance," AdvaMed's Zach Rothstein said.
By Meg Bryant • Aug. 1, 2018 -
Currency hit wipes out growth at Fresenius' dialysis device unit
The renal disease specialist reaffirmed its 2018 guidance but needs a strong second half of the year to meet its goals.
By Nick Paul Taylor • Aug. 1, 2018 -
Microsoft files patent for eyeglasses-based blood pressure monitor
The device could free patients from the need to use oscillometric cuffs to track their health.
By Nick Paul Taylor • Aug. 1, 2018 -
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FDA warns about vaginal 'rejuvenation' device claims
The seven device makers notified by FDA are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
By Susan Kelly • July 31, 2018 -
Conservative think tank praises CMS proposal on DME bidding
The industry-funded Pacific Research Institute contends that the current bidding system is driving suppliers out of the market and creating supply shortages. The proposal could increase costs to Medicare.
By David Lim • July 31, 2018 -
MedTech Europe seeks 'urgent' changes to EU regs deadlines
The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products.
By Nick Paul Taylor • July 31, 2018 -
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Sienna's acne medical device flops in pivotal trials
The California-based company isn't giving up on the product, however. Its CEO said Sienna remains optimistic in its use for hair treatment.
By Andrew Dunn • July 30, 2018 -
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FDA approves Abbott's blood sugar sensor for 14-day use
The system was the first continuous glucose monitor to eliminate the need for routine finger prick tests.
By Susan Kelly • July 30, 2018 -
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FDA sets 2019 medical device user fee rates
The agency said the base fee for a premarket application received during FY 2019 is $300,000 with the base fee for an establishment registration at $4,548.
By Susan Kelly • July 30, 2018 -
CMS advisers split on procedure volume rules for TAVR
Edwards LifeSciences and Medtronic offered different takes on the current coverage policy.
By Susan Kelly • July 30, 2018 -
CMS pitches covering cardiac catheterization at surgical centers
Jefferies analysts expect the agency will eventually add coverage for knee replacements at ambulatory surgical centers.
By Susan Kelly • July 30, 2018
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