FDA Approval News | FDA Reporter

Home
»
Stories
»
FDA Approval

FDA Approval

Taxpayer Protection Alliance: Get behind gene therapy revolution

By Zeta Cross | Aug 30, 2019

CONCEPT MEDICAL INC.: Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

By Press release submission | Aug 29, 2019

4WEB MEDICAL: Announces FDA 510(k) Clearance of its Cervical Stand-Alone Interbody Fusion Device

By Press release submission | Aug 28, 2019

Latest News

BIOBEAT: First-ever: FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure

By Press release submission | Aug 26, 2019

Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. Biobeat's products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

FDA reviews data manipulation in AveXis' new gene therapy drug for children

By Kayla Elder | Aug 25, 2019

One month after the approval of a new gene therapy drug for a rare disease in children, the Food and Drug Administration was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue.

FDA warning about the side effects of Miracle Mineral Solution

By Keri Carbaugh | Aug 24, 2019

The Miracle Mineral Solution has been a concern of the Food and Drug Administration since 2010. Once again, the FDA is warning people not to buy these products because, once the solution is mixed, it develops into a harmful bleach, causing a variety of serious and potentially life-threatening side effects.

New cloud-based vital signs measurement system approved by FDA

By Keri Carbaugh | Aug 24, 2019

The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.

SEELOS THERAPEUTICS: Announces FDA Acceptance of IND Application for SLS-005 for Mucopolysaccharidosis Type III (Sanfilippo Syndrome)

By Press release submission | Aug 23, 2019

Seelos to Proceed with Trial Enrollment and Dosing for Phase IIb/III Trial for Sanfilippo Syndrome Type A and B Patients

MIRACOR MEDICAL: Granted FDA Breakthrough Device Designation for the PiCSO Impulse System

By Press release submission | Aug 23, 2019

Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients.

FDA approvals of new drugs, biological products dip slightly in FY2019

By FDA Reporter Submission | Aug 22, 2019

New drug and biological product approvals were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

SURGENTEC: Announces FDA Clearance for Neurostimulation with ALARA™ Access Needle Kit

By Press release submission | Aug 22, 2019

Announces Participation in the 2019 North American Spine Society (NASS) Annual Meeting

VYAIRE MEDICAL: Receives FDA Clearance of New Pulmonary Function Testing Technology

By Press release submission | Aug 20, 2019

Vyntus™ ONE, Vyntus™ BODY and SentrySuite™ Software Available to U.S. Healthcare Market Immediately

BOSTON SCIENTIFIC CORPORATION: Announces FDA Approval Of ImageReady™ MRI For Vercise Gevia™ Deep Brain Stimulation System

By Press release submission | Aug 19, 2019

Boston Scientific Corporation (NYSE:BSX) announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™ Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment.

ADAGIO MEDICAL: Announces US FDA Investigational Device Exemption Approval With Conditions To Conduct A Clinical Study For Treatment Of Persistent Atrial Fibrillation Using The Ultra-Low Temperature Cryoablation System

By Press release submission | Aug 19, 2019

Adagio Medical, Inc. (Adagio), the developer of iCLAS™, the company's ultra-low temperature intelligent continuous lesion ablation system, announced that it has received an Investigational Device Exemption approval with conditions from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for persistent atrial fibrillation (AF).

PROFOUND MEDICAL: Receives U.S. FDA 510(k) Clearance for TULSA-PRO®

By Press release submission | Aug 17, 2019

U.S. Commercial Launch Expected in the 4th Quarter of 2019

Dynacure receives orphan drug designation for drug to treat Centronuclear Myopathies

By Keri Carbaugh | Aug 16, 2019

DYN101, an investigational antisense medication for Centronuclear Myopathies (CNM), has received Orphan Drug Designation, according to the drug development company Dynacure.

GENETECH: FDA Approves Genentech’s Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

By Press release submission | Aug 15, 2019

First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain

CONSOLIDATED CONTAINER COMPANY: Envision Plastics First to Be Granted NOL by the FDA to Create Food Packaging From Recycled OceanBound Plastic

By Press release submission | Aug 14, 2019

Many companies and brands have made significant, public commitments regarding sustainability.

SHIMADZU MEDICAL SYSTEMS: Receives FDA 510(k) for the FLUOROspeed X1 RF system

By Press release submission | Aug 12, 2019

Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, is proud to announce that they have received FDA 510(k) clearance for the FLUOROspeed X1, patient side conventional RF table system.

Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation

By Keri Carbaugh | Aug 9, 2019

The U.S. Food and Drug Administration has granted breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) based on clinical data from the 2019 American Society of Clinical Oncology (ASCO) annual meeting.

Trending

1 FUNCTIONAL NEUROMODULATION: Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer's Disease

FDA Reporter