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Medical Devices

March 16, 2018 | Daily News

CMS granted broader coverage than it originally proposed for diagnostic laboratory tests using next generation sequencing, a breakthrough technology considered key to advancing personalized medicine that was approved following an unusual parallel review by CMS and FDA. CMS will not make labs study the diagnostics in return for covering them.

March 15, 2018 | Daily News

FDA released Thursday (March 15) its much-anticipated advance notice of proposed rulemaking seeking public input on a standard level of nicotine for combustible cigarettes.

March 14, 2018 | Daily News

Several dozen protesters with the disability advocacy group ADAPT have camped outside of the condominium of FDA commissioner Scott Gottlieb since Friday, March 9, demanding the commissioner finalize a regulation, proposed in 2016, that would ban the use of electric shock devices to modify behavior in people with disabilities.

March 13, 2018 | Daily News

A device maker, clinical endocrinologists and advocates for diabetics are asking CMS to reverse a policy that a consultant says sets a bad precedent for Medicare coverage of remote patient-monitoring technologies such as telehealth.

March 09, 2018 | Daily News

FDA issued warning letters to duodenoscope manufacturers Olympus, Fujifilm and Pentax for failing to comply with postmarket surveillance requirements that would help determine whether health care facilities were able to properly clean and disinfect the companies' devices, the agency announced on Friday (March 9).

March 07, 2018 | Daily News

LAS VEGAS -- The National Institute of Standards and Technology within the next few weeks will request industry participation in a proposed project for improved security of patient imaging, archiving and communications systems, as part of a broader NIST effort to assist healthcare providers and device manufactures address the growing threat of cyber attacks.

March 06, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Tuesday (March 6) spotlighted the agency’s efforts to reform the premarket review process for diagnostic tests, and he previewed next steps, which include qualifying third-party reviewers and third-party databases to help with reviews and approvals, reducing regulatory burden on next generation sequencing (NGS) developers, and providing flexibility in clinical analysis and validation.

March 06, 2018 | Daily News

FDA on Tuesday (March 6) granted marketing authorization -- with special controls -- for the first time for a direct-to-consumer (DTC) genetic health report detecting whether users are at risk of developing breast and ovarian cancer.

February 22, 2018 | Daily News

Presented with compelling evidence, FDA will allow device sponsors to sidestep a requirement that companies demonstrate their clinical investigations -- conducted both inside and outside the United States -- followed good clinical practices (GCPs), including human subjects protections, the agency announced in a final rule released Tuesday (Feb. 20).

February 13, 2018 | Daily News

The head of Blue Cross Blue Shield Association's clinical evaluation, innovation and policy shop 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 13, 2018 | Daily News

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

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).