The Latest Cardiac and Vascular News
AngelMed Guardian® System prompts high-risk ACS patients to seek medical care EATONTOWN, N.J., June 28, 2021 /PRNewswire/ — Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the FDA approval of the second-generation AngelMed Guardian® device. The AngelMed Guardian System […]
Now available in the U.S., RED™ 62 is engineered with optimized trackability to help navigate the complex distal vessel anatomy in the brain and deliver powerful aspiration for the removal of blood clots First catheter of new RED series expands the company’s extensive portfolio of innovative stroke products ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, […]
LOS ALTOS HILLS, Calif.–(BUSINESS WIRE)–Fist Assist Devices, LLC, has received FDA 510(k) clearance for use of the Fist Assist FA-1 device in the United States as an arm massage and increased vein circulation device and has commenced marketing the Fist Assist FA-1 device for that indication for use. “We are […]
Charlottesville, VA June 22, 2021 – Caretaker Medical, developer of the Caretaker™ Wireless Hemodynamic Patient Monitor has been selected for MedTech Innovator’s Annual Showcase and Accelerator for 2021. Caretaker Medical was selected from a field of over 1100 companies across 50 countries as one of the Top 50 MedTech firms […]
PARIS–(BUSINESS WIRE)–Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its Clotild® Smart Guidewire System designed […]
– First and Only Approval to Indicate Cryoablation as an Initial Rhythm Control Strategy – Offers Safe, Effective Alternative to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrythmia Recurrence DUBLIN, June 21, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it received U.S. Food and Drug […]
FDA action expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 16, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension […]
Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication COPENHAGEN, Denmark–(BUSINESS WIRE)–Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has […]
SILVER SPRING, Md., June 3, 2021 /PRNewswire/ — The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and […]
IRVINE, Calif., June 1, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance. This is the first noninvasive solution that unlocks Acumen HPI software and uses machine learning to alert clinicians of the […]
