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Medical Devices

April 26, 2018 | Daily News

Leading medical device industry groups suggested during a closed-door meeting on Capitol Hill this week that the industry's future depends on Congress overhauling CMS' coverage process to ensure breakthrough devices approved by FDA also are promptly reimbursed as additional data are collected.

April 20, 2018 | Daily News

Industry attorneys are skeptical that a new draft FDA guidance expanding the abbreviated 510(k) pathway will lead to a dramatic increase in submissions under the pathway, which has been dogged by slow review times and low industry interest.

April 19, 2018 | Daily News

FDA announced Tuesday (April 17) a five-pronged medical device safety plan that proposes sweeping changes to the way the device center functions, including reorganizing the center to be one large office made up of seven smaller offices that follow individual devices through their lifecycle.

April 17, 2018 | Daily News

FDA's device center may ask Congress for authority to require medical device makers build cybersecurity into their upfront product designs and, once a product is marketed, to disclose any vulnerabilities as they are identified.

April 12, 2018 | Daily News

FDA released two final and one draft guidance Thursday (April 12) aimed at streamlining the process by which in-vitro diagnostic manufacturers can come to market, and the newly unveiled policies may allow certain Next Generation Sequencing tests to be down classified from Class III and be exempted from premarket review.

April 12, 2018 | Daily News

FDA is seeking $70 million to create a Center of Excellence on Digital Health, which would be tasked with crafting a new regulatory approach toward these products, akin to what FDA is already piloting with its software pre-cert program, according to budget material sent to congressional appropriators.

April 09, 2018 | Daily News

FDA announced Monday (April 9) it is restricting the sale and distribution of Essure, a permanent contraceptive device, by limiting the device to prescription use and requiring labeling that specifies the training or experience practitioners must have to prescribe and implant the product.

April 03, 2018 | Daily News

An FDA-sponsored survey on enhanced cybersecurity for medical devices has found competing influences -- from regulatory requirements to purchasing demands -- that must be overcome to ensure device safety and improved medical treatments.

March 27, 2018 | Daily News

The medical device industry is excited about what one representative from a top company recently called a culture change at FDA, which has been buoyed by what one lawyer called a flurry of legislation affecting the space.

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.

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