The Latest
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FDA OKs quarterly reporting of device malfunction summaries
The change is intended to reduce regulatory burdens by lowering reporting requirements.
Medical Devices -
FDA details export certificate appeal process in draft guidance
The document sets out why the agency may deny requests and how manufacturers can respond.
Policy & Regulation -
Early A1C test may reduce gestational diabetes risk: NIH study
The NIH researchers analyzed records from the NICHD Fetal Growth Study of more than 2,000 low-risk pregnant women from 12 U.S. clinical sites between 2009 and 2013.
Clinical Trials -
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.
Policy & Regulation -
AngioDynamics buys biopsy sealant technology from Surgical Specialties
The acquisition will expand the company’s portfolio of oncology devices.
Medical Devices -
Medtronic starts selling drug-coated balloon in Japan
Studies have linked the device to lasting improvements in patients with peripheral artery disease.
Medical Devices -
Aetna International pitches vision for interoperable health platform
The overseas wing of the health insurer thinks more stakeholders need to tackle data challenges.
Digital Health -
Best Buy snaps up health services company GreatCall for $800M
The acquisition may seem far afield for the electronics retailer, but in many ways it was "probably inevitable."
Digital Health -
Trump signs NIST cybersecurity bill in bid to help small businesses
The law requires NIST to provide cybersecurity resources for small businesses within one year.
Legal -
Anthem to pay record $115M to settle data breach lawsuit
The payer agreed to set aside funding for cybersecurity improvements, as well as cover two years of credit protection and $15 million worth of out-of-pocket costs for those affected.
UPDATED: Aug. 16, 2018 at 3:41 p.m.
Policy & Regulation -
DeepMind's AI detects over 50 eye diseases with 94% accuracy, study shows
The work is a collaboration between Google's DeepMind subsidiary, Moorfields Eye Hospital and University College London to speed diagnosis and referrals for sight-threatening eye diseases.
Research -
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."
Policy & Regulation -
AdvaMed pushes back against FDA humanitarian device guidance
The trade group thinks the guidance will deter development of devices to treat rare conditions.
Medical Devices -
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.
UPDATED: Aug. 15, 2018 at 11:47 a.m.
Medical Devices -
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.
Medical Devices -
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.
Policy & Regulation -
Global EHR market on track to top $39B by 2022
Among the factors driving growth are system upgrades and vendor switches, according to a new Kalorama Research report.
Research -
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.
Medical Devices -
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.
Medical Devices -
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.
Medical Devices -
Vital signs can be tampered on hospital networks, McAfee cyber report suggests
Undetected changes in vital signs could cause patients to get the wrong medication or undergo additional tests, according to McAfee.
Research -
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.
Medical Devices -
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.
Medical Devices -
NuVasive, Siemens partner on spine surgery imaging
Makers of spinal fusion devices are looking to differentiate themselves in a crowded market.
Medical Devices -
FDA OKs marketing of contraceptive app
The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.
Medical Devices