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Medical Devices

May 17, 2018 | Daily News

FDA, as it crafts a new framework to regulate artificial intelligence used in medical products, is simultaneously partnering with Harvard to look into how AI also could be used as a regulatory tool.

May 14, 2018 | Daily News

Some stakeholders are questioning the usefulness of the unified agenda in mapping out what regulatory actions FDA plans to take in the next 12 months, despite the White House’s claims that it has taken steps to make the semi-annual regulatory plan more useful to stakeholders.

May 10, 2018 | Daily News

A coalition of over 80 groups, including manufacturers, providers, laboratories and patient advocates, sent a letter Wednesday (May 9) to key members of Congress attempting to create momentum around passing legislation in 2018 revising government oversight of diagnostics, including laboratory developed tests (LDTs).

May 09, 2018 | Daily News

CMS on Wednesday (May 9) released an interim final rule that will increase pay for durable medical equipment provided in rural and other areas not covered by the competitive bidding program from June through the end of the year, and the agency says more rules are planned on rates for DME and enteral nutrition in 2019 and beyond.

May 07, 2018 | Daily News

FDA may soon release a guidance on combination product reviews and announce an initiative to offer new incentives for development of devices that manage or treat patient pain, FDA Commissioner Scott Gottlieb said at a medical device conference Thursday (May 3).

April 30, 2018 | Daily News

An industry attorney leveled a lengthy critique of FDA’s newly created Medical Device Safety Action Plan, calling different steps of the plan “extremely imperialistic,” “expansionist” and outside of FDA’s statutory authority as a regulatory agency.

April 26, 2018 | Daily News

In a speech at Datapalooza on Thursday (April 26), FDA commissioner Scott Gottlieb announced a slew of new agency initiatives aimed at spurring use of data analytics and digital health tools in regulatory decision making and drug development.

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.

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