News | 06.01.20
FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients With Right Heart Failure
June 1, 2020—Abiomed announced that the FDA has issued an emergency use authorization (EUA) for the company’s Impella RP to include patients with COVID-19–related right heart failure or decompensation, including pulmonary embolism (PE).
News | 04.03.20
European Commission Postpones Medical Devices Regulation by 1 Year to Prioritize COVID-19 Response
April 3, 2020—The European Commission (EC) announced the adoption of a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by 1 year to allow European Union (EU) member states, health institutions, and economic operators to prioritize the fight against the coronavirus pandemic.
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 | 01.16.20
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 | 10.31.19
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 | 10.22.19
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 | 02.06.19
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 | 11.25.18
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.
Article | September/October 2018
News | 07.25.18
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.