Medical Devices: Page 175
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AdvaMed pushes back against FDA humanitarian device guidance
The trade group thinks the guidance will deter development of devices to treat rare conditions.
By Nick Paul Taylor • Aug. 15, 2018 -
With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.
By Nick Paul Taylor • Updated Aug. 15, 2018 -
Explore the Trendlineâž”
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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 -
BARDA, J&J team to crowdsource respiratory device ideas
The HHS arm will work with the drugmaker's JLabs, which runs a program challenging scientists, companies and entrepreneurs to come up with bankable ideas.
By Susan Kelly • Aug. 14, 2018 -
FDA approves one-year contraceptive ring
The product, developed by the nonprofit Population Council, will be made available in the U.S. through a license agreement with women's health company TherapeuticsMD.
By Susan Kelly • Aug. 14, 2018 -
FDA sets out vision to use real-world data in product evaluations
The agency wants insights into safety and efficacy outside of controlled research environments.
By Nick Paul Taylor • Aug. 14, 2018 -
Deep Dive
Medical device industry caught in US-China trade war
"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.
By Meg Bryant • Aug. 13, 2018 -
NuVasive, Siemens partner on spine surgery imaging
Makers of spinal fusion devices are looking to differentiate themselves in a crowded market.
By Susan Kelly • Aug. 13, 2018 -
Most recalled foot, ankle devices are 501(k) approved, study finds
The less-demanding 510(k) process "may cause the devices to carry a greater risk to patients" due to a lack of clinical data, researchers said.
By Susan Kelly • Aug. 13, 2018 -
FDA OKs marketing of contraceptive app
The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.
By Susan Kelly • Aug. 13, 2018 -
Burn treatment earns expanded compassionate use approval
The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.
By Susan Kelly • Aug. 10, 2018 -
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 -
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 -
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 -
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 -
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 -
Deep Dive
Industry 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
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