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Updated: 11 min 54 sec ago

TRIMEDX to Buy Aramark’s Healthcare Technologies Business

Mon, 2018-09-17 23:00
Two major providers of healthcare technology management services are coming together. TRIMEDX, an Indianapolis-based company focused on clinical asset management and clinical engineering services, has announced a $300 million purchase of Philadelphia-based Aramark’s Healthcare Technologies (HCT) business.

FDA Updates Guidance on Voluntary Consensus Standards

Mon, 2018-09-17 23:00
The Food and Drug Administration (FDA) has issued two guidance documents updating how the agency approaches voluntary consensus standards, one on their use for premarket evaluation of medical devices and the second on how standards are recognized and withdrawn. The first document is final guidance from the FDA, and the second was issued in draft form.

FDA Plans to Streamline Third-Party 510(k) Reviews

Thu, 2018-09-13 23:00
The FDA has announced a framework to streamline third-party reviews of certain lower-risk medical devices.

FDA Issues Draft Guidance on Considering Uncertainty in Device Submissions

Wed, 2018-09-05 23:00
The Food and Drug Administration (FDA) has issued draft guidance intended to update how the agency approaches acceptable levels of uncertainty when determining the benefits and risks of medical devices during certain premarket submissions.

Facebook, NYU School of Medicine Collaborate to Improve MRIs

Mon, 2018-08-27 23:00
In an effort to improve healthcare technology, two very different organizations are teaming up—social media giant Facebook and the New York University (NYU) School of Medicine’s Department of Radiology. The two institutions have announced a collaborative research project to improve the speed of magnetic resonance imaging (MRI) scanning through the use of artificial intelligence (AI).

FDA Examines Barriers to Pediatric Technology Development

Mon, 2018-08-20 23:00
In many instances, the medical devices available in the pediatric field lag behind their adult counterparts or don’t exist at all, forcing clinicians to use adult devices off-label for children or rely on older technology. To address the issues forestalling pediatric medical device development, the Food and Drug Administration (FDA) convened a public meeting and workshop last month, delving into the financial, regulatory, and design constraints.

FDA Explains Process for Denial of Certificate to Foreign Government for Devices

Sun, 2018-08-19 23:00
The Food and Drug Administration (FDA) is accepting comments until Oct. 16 on draft guidance explaining why the agency may deny issuing a Certificate to Foreign Government (CFG) to medical device manufacturers.

Study Finds Most Wearable Devices Lack Independent Validation

Sun, 2018-08-12 23:00
Popular wearable devices, such as watches that track metabolism or sleep patterns, represent a booming, new frontier in health technology. But according to a recent article published in the open-access journal Frontiers in Physiology, there is little data that shows how—or how well—these devices provide useful health-related information to wearers.

FDA User Fees Set to Rise in 2019

Mon, 2018-08-06 23:00
The Food and Drug Administration (FDA) has announced its medical device user fees for fiscal year 2019.

FDA Issues Final Guidance on Use of EHR Data in Clinical Investigations

Wed, 2018-08-01 23:00
As part of the Food and Drug Administration’s (FDA’s) ongoing effort to streamline and modernize clinical investigations, the agency has issued final guidance that specifies when and how researchers can use data from electronic health records (EHRs) to assess the safety and efficacy of medical devices, combination products, and other healthcare products.

FDA Approves First Smartphone Camera-Based Device for Clinical Diagnostics

Thu, 2018-07-26 23:00
In a first for the U.S. healthcare technology industry, the Food and Drug Administration (FDA) has granted Class II approval to a device that uses a smartphone-based camera to provide clinical-grade diagnoses. The landmark approval comes as the increasing power of smartphone sensors, processing power, displays, and connectivity continues to push the boundaries of traditional medical devices and transform healthcare delivery.

Global Regulators Promote UDI Standardization with New Guide

Mon, 2018-07-23 23:00
With a goal of establishing a globally harmonized system for unique device identification (UDI), the International Medical Device Regulators Forum (IMDRF) has released a proposed UDI Application Guide for public comment.

VA, IBM Watson Extend ‘Cancer Moonshot’ AI Partnership

Sun, 2018-07-22 23:00
In a move that highlights the expanding role of artificial intelligence (AI) in guiding healthcare treatment decisions, the U.S. Department of Veterans Affairs (VA) and IBM Watson Health have announced the extension of a two-year public-private partnership to interpret cancer data for VA patients.

Industry Provides Mixed Reaction to ‘Modernized’ 510(k) Premarket Clearance Program

Tue, 2018-07-17 23:00
The Food and Drug Administration’s (FDA) proposal to "modernize" its approach to clearing moderate-risk devices by establishing an expanded version of the Abbreviated 510(k) program was met with a wide array of responses during its commenting period, which ended July 11. Some groups lauded the agency’s effort to streamline the clearance of some medical devices, while others expressed concerns over the plan’s implementation and potential effects on patient safety.

Google Team Predicts Readmissions, Deaths using EMR Data

Sun, 2018-07-15 23:00
Researchers for the Internet search provider Google have leveraged the company’s expertise in deep-learning to accurately analyze and predict medical events using raw data from electronic health records (EHRs), according to a study published in the open-access journal npj Digital Medicine.

Medical Device Industry Braces for Tariffs on Chinese Goods

Tue, 2018-07-10 23:00
The U.S. medical device industry is bracing for the effects of wide-ranging tariffs on Chinese goods announced by President Donald Trump’s administration, many of which went into effect last week. This first round of 25% tariffs covers 818 products imported from China, worth more than $34 billion, according to the Office of the U.S. Trade Representative (USTR). That list includes several products directly and indirectly related to the medical device industry, such as X-ray tubes, electromedical imaging components, and parts of certain medical and surgical sterilizers, among others.

ACI Board Seeks Feedback on Possible Retirement of Three Certifications

Mon, 2018-07-09 23:00
Following discussions during its meeting at the AAMI 2018 Conference & Expo in June, the AAMI Credentials Institute Board of Directors is considering retiring the Certified Laboratory Equipment Specialist (CLES), Certified Radiology Equipment Specialist (CRES), and Certified Quality System Manager (CQSM)exams but is seeking feedback from the community before taking action.

Vote on Medical Device Tax Repeal Expected this Month

Sun, 2018-07-08 23:00
Nearly six months after a funding bill was signed into law that temporary suspended the 2.3% excise tax on medical devices, a renewed effort is underway to eliminate the tax permanently before it is scheduled to come back into force in fewer than 18 months.

GE to Spin Off Healthcare Business

Mon, 2018-07-02 23:00
GE Healthcare, the $65-billion division of General Electric (GE) known for its expertise in medical imaging, monitoring, biomanufacturing, cell therapy, artificial intelligence, and data analytics, is spinning off from its 126-year-old parent company. The healthcare business unit generated more than $19 billion in revenue last year, but the separation will allow for a “simpler” and ”leaner” GE moving forward, according to the company.

Proposed CMS Interoperability Rule Draws Mixed Reactions

Thu, 2018-06-28 23:00
A proposed rule by the Centers for Medicare & Medicaid Services (CMS) that would tie interoperability—in terms of the electronic exchange of information—to funding for Medicare and Medicaid has received a mixed reaction from industry groups.

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