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Medical Devices

February 13, 2018 | Daily News

The head of the Blue Cross Blue Shield Association questions whether FDA's proposed software precertification program -- which would allow certain companies to take new medical software to market more easily -- will offer adequate clinical evaluations of safety and effectiveness.

February 12, 2018 | Daily News

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

February 08, 2018 | Daily News

FDA, working with the Nuclear Regulatory Commission, approved NorthStar Medical Radioisotopes' RadioGenix System, a “novel manufacturing system” to produce a non-uranium version of radioisotope technetium-99m (Tc-99m), a diagnostic agent used in nuclear imaging studies to detect cancer and coronary artery disease, FDA and Commissioner Scott Gottlieb announced in simultaneous press statements on Thursday (Feb. 8).

February 02, 2018 | Daily News

The nine major medical device and technology companies selected by FDA last fall to be a part of the agency's digital health pre-cert pilot program praised the agency and the program at a two-day public workshop held this week at the National Institutes of Health.

January 29, 2018 | Daily News

An FDA expert panel rejected Philip Morris International’s claim that its smokeless tobacco product, IQOS, could reduce users’ risk of tobacco-related disease, but the experts did approve of the company's claim that the product would reduce a user's exposure to harmful chemicals.

January 26, 2018 | Daily News

CMS tells Inside Health Policy it is exploring new ways to provide patients timely access to emerging technologies after axing a proposed rule that had been sitting at the White House budget office since April.

January 12, 2018 | Daily News

FDA announced on Friday (Jan. 12) that it will continue to delay until further notice a controversial regulatory measure that would factor “the totality of the evidence” into agency decisions regarding a drug or device manufacturer's intended use of a product and communications about such uses.

January 12, 2018 | Daily News

FDA Friday (Jan. 12) significantly delayed the date by which class I and unclassified devices must bear a unique device identifier (UDI).

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 04, 2018 | Daily News

The National Health Information Sharing and Analysis Center's Threat Intelligence Committee has alerted the healthcare sector to two new cybersecurity threats, the NH-ISAC TIC announced Thursday.

December 29, 2017 | Daily News

Legal experts representing the clinical decision support (CDS) software industry take strong issue with FDA's draft guidance on CDS software, published Dec. 7.

December 28, 2017 | Daily News

FDA from 2008 to 2014 saw a roughly 500 percent increase in the number of premarket submissions that include patient-reported outcome (PRO) measures, but there are still challenges the agency needs to tackle when it comes to incorporating PROs into device approvals, including enhancing training, transparency and expertise, and reducing sponsor uncertainty, according to the agency's first PRO report released Dec. 12.

December 21, 2017 | Daily News

FDA is seeking nominations for patient advocates to participate in a Patient Engagement Collaborative (PEC), which will bring FDA and the patient community together to discuss patient engagement in medical product development and other regulatory issues, the agency announced in the Federal Register on Wednesday (Dec. 20).

December 14, 2017 | Daily News

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

December 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices.

December 07, 2017 | Daily News

FDA and CMS will increasingly work together on simultaneous diagnostic test reviews, a move that FDA Commissioner Scott Gottlieb told lawmakers Thursday (Dec. 7) could serve as “a powerful incentive” for more sponsors of diagnostic tests to voluntarily go through the FDA approval process.

December 07, 2017 | Daily News

FDA on Thursday (Dec. 7) took steps to fulfill the digital health provisions in the 21st Century Cures Act by issuing a suite of guidances that reveal which clinical decision support (CDS) tools won't be considered devices.

December 07, 2017 | Daily News

FDA last week approved the first medical device cleared for use with the Apple Watch following a 19-month review process largely due to the complexity and potential risk of the product's software, which can interpret diagnostic tests without any physician involvement.

December 05, 2017 | Daily News

FDA published final guidance Monday (Dec. 4) aimed at helping CMS determine which investigational devices to cover by streamlining the categorization of investigational device exemption (IDE) products -- completing a process launched in 2015 through a Memorandum of Understanding (MOU) between FDA's device center and CMS' Coverage and Analysis group (CAG).

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