Medical Devices
-
FDA finds higher death, stroke rates for latest SynCardia artificial heart driver
The agency said it will work with SynCardia to ensure product labeling addresses the post-approval findings.
By Susan Kelly • Aug. 20, 2018
-
Noninvasive magnetic stimulation for OCD wins FDA nod
The agency's clearance for OCD is an extension of a 2008 approval of transcranial magnetic stimulation to treat major depression.
By Susan Kelly • Aug. 20, 2018
-
Doctors often fail to list conflicts in device studies: JAMA report
Doctors got the highest payouts from Medtronic, which accounted for more than $187.4 million, followed by Stryker and Intuitive Surgical, according to a JAMA analysis.
By Susan Kelly • Aug. 20, 2018
-
In pursuit of new insulins, Novo may drop more than $800M on Ziylo
Pricing pressures and competition have pushed diabetes drugmakers to innovate. Novo's looking to do just that in buying the University of Bristol spinout and its glucose-binding molecules.
By Jacob Bell • Aug. 17, 2018
-
FDA OKs quarterly reporting of device malfunction summaries
The change is intended to reduce regulatory burdens by lowering reporting requirements.
By Nick Paul Taylor • Aug. 17, 2018
-
Teva granted FDA approval for first EpiPen generic
It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.
By David Lim • Aug. 16, 2018
-
AngioDynamics buys biopsy sealant technology from Surgical Specialties
The acquisition will expand the company’s portfolio of oncology devices.
By Nick Paul Taylor • Aug. 16, 2018
-
Medtronic starts selling drug-coated balloon in Japan
Studies have linked the device to lasting improvements in patients with peripheral artery disease.
By Nick Paul Taylor • Aug. 16, 2018
-
Healthix switching software vendors for patient matching
The nation's largest public health information exchange will switch to software vendor Verato in a bid to improve its patient-matching capabilities.
By Susan Kelly • Aug. 15, 2018
-
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 at 11:47 a.m.
-
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 DiveMedical 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. 09, 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. 08, 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. 08, 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. 07, 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. 07, 2018