Policy & Regulation
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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
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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
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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
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US agencies pitch efforts to spur gene therapy development
The chiefs of the FDA and NIH laid out proposals in a New England Journal of Medicine editorial aimed at pushing forward advances in the fast-expanding field.
By Suzanne Elvidge • Aug. 17, 2018
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FDA details export certificate appeal process in draft guidance
The document sets out why the agency may deny requests and how manufacturers can respond.
By Nick Paul Taylor • Aug. 17, 2018
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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
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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
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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
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Maryland failed to secure its Medicaid data: OIG
Exploitation could have resulted in unauthorized access to data and disruption of critical operations, but the inspector general did not identify evidence that the system was compromised.
By Susan Kelly • Aug. 15, 2018
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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
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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
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Verma touts interoperability, corporate partnerships at Blue Button 2.0 conference
Microsoft, Google and Amazon pledged at the event they are committed "to removing barriers for the adoption of technologies for healthcare interoperability, particularly those that are enabled through the cloud and AI."
By David Lim • Aug. 14, 2018
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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
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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
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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
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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
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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
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TGA seeks industry input on cybersecurity, medtech software guidance
The agency has commissioned reports to inform approaches that support companies and protect patients.
By Nick Paul Taylor • Aug. 10, 2018
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FDA warns manufacturing fault with membrane test creates fetal death risk
The rupture test results could be misinterpreted, leading to serious adverse events.
By Nick Paul Taylor • Aug. 09, 2018
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UnityPoint's second data breach this year could prompt expanded lawsuit
The Des Moines-based nonprofit notified 1.4 million people last week that a phishing attack may have compromised their information.
By Meg Bryant • Aug. 08, 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. 08, 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. 07, 2018
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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. 07, 2018
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FCC seeks comments on $100M telehealth pilot
The commission noted many low-income consumers, especially in rural areas, lack access to affordable or adequate broadband.
By Susan Kelly • Aug. 06, 2018
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NIST offers 'how to' for securing EHRs on mobile devices
Such devices are ubiquitous in healthcare, raising concerns about security and privacy of personal health information.
By Meg Bryant • Aug. 03, 2018