Forgot password?
Sign up today and your first download is free.

Medical Devices

April 29, 2019 | Daily News

The American Society for Radiation Oncology is urging Congress to revamp the prior authorization process, which oncologists surveyed by the group say delays cancer treatments.

April 25, 2019 | Daily News

Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

April 25, 2019 | Daily News

A leading pediatric neurologist said he welcomed FDA’s approval of the first-ever device for treating attention-deficit/hyperactivity disorder (ADHD).

April 25, 2019 | Daily News

FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.

April 23, 2019 | Daily News

CMS proposes raising the add-on pay for new technology and providing a path for breakthrough devices approved by the FDA to access add-on payments as part of the proposed fiscal 2020 hospital inpatient pay rule released Tuesday (April 23) -- a move the medical device lobby praised for including several of the industry’s suggestions.

April 23, 2019 | Daily News

FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).

April 23, 2019 | Daily News

A month after reporting it received tens of thousands of adverse events associated with surgical staplers and staples, FDA is stepping up its regulation of the devices by: issuing a proposed order to upclassify the Class I devices as Class II; issuing draft guidance on labeling recommendations to ensure adequate use; and scheduling a public meeting on May 30 to gather input on the first two efforts.

April 22, 2019 | Daily News

In the wake of a 35-day partial government shutdown that furloughed 41 percent of the agency’s staff earlier this year, a group of FDA policy experts sent a letter to the agency asking for more details on how much funding FDA had and from what sources; exactly how many personnel were exempted, excepted and furloughed throughout the shutdown; and how FDA is preparing for future shutdowns.

April 19, 2019 | Daily News

As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.

April 18, 2019 | Daily News

FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16).

April 12, 2019 | Daily News

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

April 12, 2019 | Daily News

New findings from duodenoscope sampling studies show the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what FDA originally reported back in 2018, the agency’s device center director announced Friday (April 12).

April 11, 2019 | Daily News

Device stakeholders have another 30 days to comment on FDA’s proposal to post on its website cleared devices that demonstrated substantial equivalence to older predicate devices as part of its bid to encourage device makers to use new predicates.

April 09, 2019 | Daily News

The new chairman of the Advanced Medical Technology Association’s (AdvaMed’s) board of directors, Kevin Lobo, says the most pressing issue facing the industry is the Affordable Care Act’s 2.3 percent excise tax on medical devices, the latest moratorium on which ends next year.

April 08, 2019 | Daily News

Since his early March announcement that he would be leaving FDA, former agency commissioner Scott Gottlieb ramped up work to wrap up, or initiate, myriad goals he wanted to accomplish during his time with the agency.

April 02, 2019 | Daily News

In a white paper released Tuesday (April 2), FDA details an oversight process that outgoing agency commissioner Scott Gottlieb said could allow artificial intelligence-based medical devices to iterate autonomously while still letting FDA provide a reasonable assurance of safety and effectiveness.

March 28, 2019 | Daily News

American Clinical Laboratory Association (ACLA) president and CEO Julie Khani said she looks forward to starting a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics.

March 28, 2019 | Daily News

FDA is proposing to amend its regulatory framework for mammograms and mammography facilities, which would include for the first time a federal requirement that breast density information be included in communications to patients and health care providers, the agency announced Wednesday (March 27).

March 28, 2019 | Daily News

FDA Commissioner Scott Gottlieb says his agency is looking into less environmentally hazardous methods of medical device sterilization after the Illinois Environmental Protection Agency ordered a large sterilization facility to close in February due to ethylene oxide emissions.

March 21, 2019 | Daily News

Durable medical equipment lobbyists took their fight against adding ventilators to the competitive bidding program to the White House Domestic Policy Council after vowing to pressure the administration and Congress to change the policy.