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Medical Devices

June 11, 2018 | Daily News

House lawmakers introduced a draft hazard preparedness reauthorization bill that would enhance FDA’s emergency use authorities and direct the agency to work toward developing medical countermeasures with regard to cybersecurity threats.

June 07, 2018 | Daily News

Representatives of large medical device manufacturing companies discussed methods for reducing obstacles to financing and marketing new medical devices with HHS Secretary Alex Azar during a roundtable discussion Thursday (June 7), according to an HHS readout of the meeting.

June 05, 2018 | Daily News

In a move opposed by genetics professionals, FDA published a final order Friday (6/1) that put genetic health risk assessment systems on a list of Class II medical devices exempted from premarket notification 510(k) requirements, subject to certain limitations.

June 01, 2018 | Daily News

FDA's decision to take a hands-off approach toward medical device servicing has left servicers and device makers at odds: Servicers praise the move, but device manufacturers are upset and say Congress must now step in to require at least some minimal level of federal oversight.

May 30, 2018 | Daily News

FDA is offering special incentives in its quest for medical and digital health device developers to submit proposals for “novel solutions” for detecting, treating and preventing addiction and for addressing diversion and treating pain, the agency said in a press announcement Wednesday (May 30).

May 30, 2018 | Daily News

The American Hospital Association strongly supports FDA’s draft Medical Device Safety Action Plan, but says the agency needs to act swiftly and should take additional steps to ensure devices are protected from cyber attacks.

May 29, 2018 | Daily News

CMS plans to restart a tweaked version of a home health demonstration that it stopped just over a year ago following concerns from beneficiary advocates as well as home health providers that said the demo found more paperwork errors than fraud.

May 29, 2018 | Daily News

FDA on Tuesday (May 29) opened a public docket to gather input on the benefits and risks to health associated with medical software functions excluded from the definition of a medical device in the 21st Century Cures Act.

May 25, 2018 | Daily News

The Congressional Budget Office estimates that a proposal in the president's fiscal 2019 budget to expand and reform competitive bidding for durable medical equipment would cost $1.3 billion over 10 years, a stark contrast to HHS’ estimate the plan would save $6.5 billion over the same time period.

May 22, 2018 | Daily News

A Senate Appropriations subcommittee on Tuesday (May 22) voted unanimously to send to the full committee a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

May 22, 2018 | Daily News

Device industry lawyers say a rule proposed by FDA May 15 to revamp how the agency classifies combination products, while including some beneficial changes, doesn't fix fundamental problems that make the process frustrating for industry.

May 22, 2018 | Daily News

Device industry lawyers say FDA Commissioner Scott Gottlieb’s recent announcement of a data science incubator could lead to creation of large public databases of clinical evidence that genetic test developers could use to support clinical claims for their products.

May 21, 2018 | Daily News

The U.S. Supreme Court Monday (May 21) declined to take up a case brought by a coalition of drug makers challenging consumers' standing to sue over money lost due to a product design that allegedly wastes a portion of that product.

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.