FDA

DAIC's Top 10 for November
November was a busy month with many FDA approvals and breaking clinical trial results. Take a look at the news making top headlines that you might have missed during the month of November. 1. BLOG ...
Medtronic Announces FDA Approval of Minimally Invasive Device to Treat Hypertension
November 20, 2023 — Medtronic plc, a global leader in healthcare technology, announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral renal denervation ...
Renal Denervation Systems Receive FDA Approval, Revolutionizing Treatment for Uncontrolled Hypertension
November 20, 2023 — A groundbreaking advancement in the treatment of patients with uncontrolled hypertension (HTN) has been achieved with the recent U.S. Food & Drug Administration (FDA) approvals of ...
First FDA Approval of Renal Denervation System to Treat Hypertension Announced by Recor Medical and Otsuka Medical Devices
November 8, 2023 — Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise Ultrasound ...

Take a look at the news making top headlines during the month of November on dicardiology.com

Feature | Cardiovascular Business | By Melinda Taschetta-Millane

November was a busy month with many FDA approvals and breaking clinical trial results. Take a look at the news making ...

December 05, 2023

The device would be the first clinical-grade, diagnostic wrist-worn device for long term Afib monitoring

News | Wearables

Clinical Smartwatch Finds Success at Identifying Atrial Fibrillation

December 1, 2023 — As the use of wearable technology grows, smartwatches are marketed across the globe to consumers as a ...

December 01, 2023

First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study)

News | FDA

Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023

November 27, 2023 — Tenax Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and ...

November 27, 2023

News | Atrial Fibrillation

Positive Results from ReVeRA Phase 2 Study of Etripamil Nasal Spray in AFib-RVR Presented by Milestone Pharmaceuticals during AHA 2023

November 24, 2023 — During the American Heart Association Scientific Sessions 2023, held recently in Philadephia, PA, Mi ...

November 22, 2023

News | Pharmaceuticals

BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

November 21, 2023 — BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and ...

November 21, 2023

New partnership paves the way for early diagnosis and intervention to improve cardiovascular outcomes and quality of life for patients

News | ECG

AccurKardia Delivers its ECG Interpretation Software Within the Lucem Health Reveal Family of Clinical AI Solutions

November 21, 2023 — AccurKardia, an ECG-led diagnostics software company, announced a multi-year agreement with Lucem ...

November 21, 2023

Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology

News | Renal Denervation

Medtronic Announces FDA Approval of Minimally Invasive Device to Treat Hypertension

November 20, 2023 — Medtronic plc, a global leader in healthcare technology, announced that the United States Food and ...

November 20, 2023

A groundbreaking advancement in the treatment of patients with uncontrolled hypertension (HTN) has been achieved with the recent U.S. Food & Drug Administration (FDA) approvals of two renal denervation (RDN) systems

News | FDA

Renal Denervation Systems Receive FDA Approval, Revolutionizing Treatment for Uncontrolled Hypertension

November 20, 2023 — A groundbreaking advancement in the treatment of patients with uncontrolled hypertension (HTN) has ...

November 20, 2023

BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol

News | FDA

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

November 17, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiova ...

November 17, 2023

Real-world evidence from the AHA Scientific Sessions 2023 demonstrated that Eko's AI doubles valvular heart disease detection sensitivity over traditional methods

News | Wearables

Multicenter Validation of the Novel Vivio System for Non-Invasive Estimation of Elevated Left Ventricular End Diastolic Pressure

November 15, 2023 — Ventric Health, a healthcare technology company and medical device provider focused on ...

November 15, 2023

Getinge announced commercial availability of the iCast covered stent system in the United States

News | Peripheral Artery Disease (PAD)

Getinge Announces U.S. Commercial Availability of iCast Covered Stent System for Treatment of Iliac Arterial Occlusive Disease

November 10, 2023 —Getinge announced commercial availability of the iCast covered stent system in the United States for ...

November 10, 2023

Further enhancing comprehensive trauma care solution

News | Artificial Intelligence

RapidAI Receives FDA Clearance of AI Module for Detection of Hemispheric Subdural Hematomas

November 9, 2023 — RapidAI, a global leader in developing artificial intelligence (AI) and technology workflow solutions ...

November 09, 2023

Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

News | FDA

First FDA Approval of Renal Denervation System to Treat Hypertension Announced by Recor Medical and Otsuka Medical Devices

November 8, 2023 — Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. has announced that the U ...

November 08, 2023

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

News | FDA

Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling

November 7, 2023 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and its subsidiary Arrow ...

November 07, 2023

News | VIVA

VIVA23 Presents Outcomes of Late-breaking Science from Abbott’s LIFE-BTK, RESOLV FIH Study, and IN.PACT AV Access Trial

November 2, 2023 — The second round of late-breaking clinical trials results from the Vascular InterVentional Advances ...

November 01, 2023