Thursday, September 19, 2019

Thursday, September 19, 2019

Latest News

LifeKit Prevent Test earns Breakthrough Device designation from FDA

The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.

FDA creating new labeling guidelines for opioid medications

The FDA has issued new draft guidance for labeling of prescription medications that could be abused, with the goal of making the risks of dependence clearer for health care providers and for patients.

New legislation proposed to regulate Pennsylvania CBD and kratom sales

Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.

EBR SYSTEMS, INC.: FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure.

FDA held 10 drug application meetings in first 9 months of FY 2019

The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.

CHECKPOINT SURGICAL: Receives FDA Breakthrough Designation for Nerve Regeneration Device

Checkpoint Surgical, Inc., a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system.

UNITED THERAPEUTICS CORPORATION: Announces FDA Acceptance Of Trevyent New Drug Application For Review

United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH).

NETECH CORPORATION: Netech Obtains FDA 510(k) Clearance for Delta 3300 - Defibrillator/Pacemaker Analyzer

Delta 3300 Is A Compact and Light Weight Precision Instrument Ideal for Testing all Defibrillators and Pacemakers

CLUEPOINTS: FDA Extends CRADA with CluePoints to Further Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.

VANTAGE SOLUTIONS: Supports FDA Pilot for Verification Router Service

Vantage Solutions, the manufacturing efficiency experts, today announced it is supporting the Food and Drug Administration (FDA) Pilot for Verification Router Service (VRS) testing sponsored by rfxcel.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality.

ANSI: National Accreditation Board (ANAB) Accredits Global Standards S.C. (GSSC) to Certify Foreign Food Supplies under U.S. FDA-FSMA Program

The ANSI National Accreditation Board (ANAB), a wholly-owned subsidiary of the American National Standards Institute, has accredited Global Standards S.C. (GSSC) in accordance with the international standard, ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services, and pertinent certification scheme requirements and regulations under the U.S. Food and Drug Administration (FDA)'s Food Safety Modernization Act, or FSMA.

BIOGENNIX: Launches Agilon Bone Grafting Solution

Company’s New Collagen-Enhanced Bone Graft Material Receives US FDA 510(k) Clearance and Enters Domestic Market

WONTECH: Holmium laser 'Holinwon Prima' Received FDA approval

WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, received U.S. Food and Drug Administration approval.

BARDY DIAGNOSTICS: Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) Patch

Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

ENDO: Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite

Endo International plc (NASDAQ: ENDP) announced today that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.

RIDGEBACK BIOTHERAPEUTICS LP: Announces receipt of Breakthrough Therapy designation from FDA for mAb114

Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.

ICUS: Simple CEUS Scan Helps Diagnose Liver Cancer When MRI is Uncertain

A new study shows that a simple, non-invasive “contrast enhanced ultrasound” (CEUS) scan can be more accurate and reliable than a more expensive MRI procedure for diagnosis of liver tumors and determining whether they are cancerous.

FDA Reporter