Medical Devices

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.

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.

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.

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.

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.

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.

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.

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.

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.