News | 03.30.20
CMS Adopts Temporary Regulatory Waivers and Rules to Manage COVID-19 Patient Surge
March 30, 2020—The Centers for Medicare & Medicaid Services (CMS) announced an array of temporary regulatory waivers and new rules to equip the American health care system with maximum flexibility to respond to the COVID-19 pandemic.
News | 02.26.20
FDA's eSTAR Program Seeks to Promote Greater Efficiency and Consistency in the 510(k) Process
February 26, 2020—The FDA announced the launch of eSTAR, a voluntary electronic submission template and resource pilot program as an alternate method available for selected industry participants in the pilot to prepare a 510(k) submission.
News | 01.17.20
Study Shows More Than Half of United States Clinical Trials Fail to Comply With Law on Reporting Results
January 17, 2020—The Lancet announced the publication of a study finding that only 41% of clinical trial results are reported promptly onto the United States trial registry, and one in three trials remain unreported.
News | 11.01.19
CMS 2020 Final Hospital Outpatient Rule Allows Reimbursement of PCI in Ambulatory Centers
November 1, 2019—The American College of Cardiology (ACC) announced that the Centers for Medicare and Medicaid Services (CMS) will release the 2020 Medicare Physician Fee Schedule final rule addressing Medicare payment and quality provisions for physicians in 2020, under which, physicians will see a virtually flat conversion factor on January 1, 2020, going from $36.04 to $36.09.
News | 10.23.19
CorFlow's Controlled Flow Infusion System Granted FDA Breakthrough Device Designation
October 23, 2019—CorFlow Therapeutics AG announced that the company has been granted FDA Breakthrough Device designation for its CorFlow controlled flow infusion (CoFI) system with an indication for diagnostic assessment of the coronary microcirculation immediately after percutaneous coronary interventions (stenting) and as a platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion.
News | 02.07.19
FDA Updates Process for Issuing Public Warnings and Notifications of Recalls
February 7, 2019—FDA Commissioner Scott Gottlieb, MD, announced new steps that the agency is taking to strengthen and modernize its process for issuing a public warning about a voluntary recall and for notification of recalls.
News | 11.26.18
FDA Announces Plans to Modernize 510(k) Program
November 26, 2018—FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH), announced proposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology.
News | 07.26.18
Edwards Responds to MEDCAC Panel Meeting on Procedural Volume Requirements for TAVR
July 26, 2018—Edwards Lifesciences commented on the US Centers for Medicare & Medicaid Services’ (CMS) advisory panel regarding evidence pertaining to procedural volume requirements for transcatheter aortic valve replacement (TAVR) programs.
News | 07.26.18
SCAI Comments on CMS MEDCAC Panel Regarding TAVR
July 26, 2018—The Society for Cardiovascular Angiography and Interventions (SCAI) released a statement commenting on the meeting of the Centers for Medicare & Medicaid Services (CMS) panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), which was convened on July 25 to provide recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs.
News | 07.02.18
CMS to Convene MEDCAC Panel to Consider Procedural Volume Requirements for TAVR
July 2, 2018—The Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on July 25, 2018 to seek MEDCAC's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain transcatheter aortic valve replacement (TAVR) programs.
News | 06.20.18
FDA Issues Draft Guidance on Performance Tests and Labeling for Guidewires
June 20, 2018—The US Food and Drug Administration (FDA) has issued a draft guidance document that provides draft recommendations for 510(k) submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature to facilitate the placement of therapeutic devices during percutaneous interventional procedures.
News | 01.22.18
FDA Seeks to Strengthen Public Warnings and Recall Notifications; CDRH Outlines Strategic Priorities
January 18, 2018—US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, issued a statement on the agency's new policy steps for strengthening public warnings and notifications of recalls.
News | 09.28.17
Magenta Medical Secures Funding for Development of Therapies for Acute Heart Failure
September 28, 2017—Magenta Medical, an Israel-based company developing therapeutic approaches to the management and treatment of acute heart failure, announced the closing of its $15 million Series B financing round.