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Medical Devices

August 01, 2019 | Daily News

A recently issued final FDA guidance clarifies key industry questions about how combination product makers should comply with postmarket safety reporting requirements (PMSR), but an industry lawyer said some of the finer points, such as details to be included in foreign event reports and the number of constituent parts in a safety report, will have to be hashed out in practice.

July 29, 2019 | Daily News

Hospitals would have to publicly post pay-specific negotiated prices of their “shoppable services,” including x-rays or caesarean deliveries, under CMS’ proposed 2020 outpatient rule, as the agency also doubles down on its site-neutral and 340B pay cut policies that hospitals have slammed.

July 29, 2019 | Daily News

CMS proposed a payment rule Monday (July 29) meant to encourage dialysis facilities to adopt new equipment and supplies while also increasing pay for those facilities and updating the pricing system for medical devices.

July 25, 2019 | Daily News

FDA last Thursday (July 18) touted positive results from its voluntary software precertification test program and laid out next steps.

July 24, 2019 | Daily News

Consumer advocacy group Public Citizen blasted FDA on Wednesday (July 24), saying the agency was too late in requesting breast implant manufacturer Allergan recall several of its textured breast implant models after new evidence emerged showing a direct link between the implants and a deadly form of lymphoma.

July 24, 2019 | Daily News

FDA on Monday (July 22) cleared a wound dressing used to treat first- and second-degree burns caused by exposure to sulfur mustard, also known as mustard gas.

July 15, 2019 | Daily News

CMS on Monday (July 15) proposed to cover acupuncture for Medicare beneficiaries with chronic low back pain who are enrolled in CMS-approved studies or clinic trials sponsored by the National Institutes of Health.

July 12, 2019 | Daily News

CMS is working on possible changes to the end stage renal disease pay system as part of a broader kidney care revamp unveiled by HHS Wednesday (July 10), as the agency says that “continual refinement of the ESRD PPS is necessary to benefit people living with ESRD.”

July 10, 2019 | Daily News

President Donald Trump calls for steps to encourage the development of wearable or implantable artificial kidneys as part of an executive order he unveiled Wednesday (July 10) to improve American kidney health.

July 10, 2019 | Daily News

Sen. Elizabeth Warren (D-MA) is still waiting for a response from FDA to a letter she and Sen. Patty Murray (D-WA) wrote last month raising concerns with a new device approval pathway proposed in the agency’s fiscal 2020 budget justification.

July 03, 2019 | Daily News

FDA on Tuesday (July 2) announced that it will meet with patients to come up ideas for how FDA, the medical device industry and health care providers should tell patients and the public about cybersecurity risks associated with devices.

June 21, 2019 | Daily News

FDA on Friday (June 21) formally scrapped its hidden database of safety incidents associated with certain medical devices and said it will beef up its public reporting program instead.

June 20, 2019 | Daily News

Sens. Bill Cassidy (R-LA) and Sherrod Brown (D-OH) are leading a Senate letter asking CMS to reconsider its plan to add non-invasive ventilators to the durable medical equipment competitive bidding program -- or at least include patient safeguards in the bidding process -- and lawmakers in the House have been collecting signatures for a similar letter, which the American Association for Homecare estimates has about 180 lawmakers on board.

June 14, 2019 | Daily News

Sen. Bill Cassidy (R-LA) is working on a bill to tighten privacy protections for health data integrated into third-party applications, including fertility or weight loss mobile apps, according to his office.

June 13, 2019 | Daily News

A device industry lawyer said FDA’s software precertification test plan could help FDA win the statutory authority it needs to implement the pre-cert program, as it could give lawmakers the evidence they need to conclude the program achieves the same level of safety validation as FDA’s traditional review pathways.

June 07, 2019 | Daily News

FDA for the first time has granted marketing authorization to a device intended to help relieve pain in adolescents with irritable bowel syndrome (IBS) through the use of electrical nerve stimulation, the agency announced Friday (June 7).

June 04, 2019 | Daily News

The House Appropriations Committee approved a 2020 funding bill on Tuesday (June 4) that would give FDA a $184 million boost over 2019 levels. During the markup, lawmakers voted to restore language featured in previous bills that would prevent the genetic modification of human embryos.

June 04, 2019 | Daily News

The United States and the United Kingdom will reach a “phenomenal trade deal” covering “everything” -- including the British National Health Service, President Trump said in London on Tuesday (June 4).

June 03, 2019 | Daily News

If a fiscal 2020 agriculture funding bill passes the House Appropriations Committee on Tuesday (June 4), FDA will be one step closer to receiving millions of dollars to support new oversight efforts in its cosmetics, supplements and food import spaces.

June 03, 2019 | Daily News

Days before the House Appropriations Committee is set to mark up an FDA funding bill, an expert on the agency’s budget process said there are plenty of challenges looming ahead that could sink the $184 million increase that House lawmakers propose in the bill.

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