Thursday, November 21, 2019

Thursday, November 21, 2019

Latest News

SURGICAL INFORMATION SCIENCES: Announces FDA 510(k) Clearance for Additional Visualization Capabilities in its DBS Targeting Software

Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market new visualization capabilities.

VIVAQUANT: Receives FDA 510(k) Clearance for its RX-1 Rhythm ExpressTM Arrhythmia Device

VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device.

RENALYTIXAI: FDA Grants Breakthrough Device Designation to KidneyIntelX™

Provides Priority Regulatory Review of AI-Enabled Diagnostic for Fast-Progressing Kidney Disease

FDA to host hearing on cannabis products

The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.

Regulatory Education for Industry Annual Conference to be held in Boston

The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.

North Carolina House introduces stem cell therapy bill

A bill proposing the right to try adult stem cell treatments was introduced in the North Carolina House on April 22.

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

Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).

HI-TECH PHARMACEUTICALS, INC.: Sues The FDA For "Its Campaign of Intimidation"

Hi-Tech Pharmaceuticals sued the FDA May 2nd, 2019 in Federal Court- Case 1:19-cv-01268, claiming the agency bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

LENSAR, INC.: LENSAR® Laser System Receives FDA Clearance to Perform Micro Radial Incisions to Optimize Outcomes of Refractive Cataract Procedures

LENSAR® Laser System with Streamline® IV Capabilities Expands to Include Micro Radial Incisions, Allowing Surgeons to Treat Additional Corneal Conditions

ABIOMED, INC.: FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial

Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial.

ONKURE, INC.: Announces FDA IND Regulatory Clearance to Start Phase 1 Trials for OKI-179

OnKure, Inc., the epigenetics-focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, announced that its lead drug, OKI-179, has cleared the FDA IND regulatory hurdle to start Phase 1 trials.

North Carolina 'Right to Try' bill now in the state Senate after unanimously passing the House

Legislation that would allow terminally ill patients to access stem cell treatments not yet signed off by the U.S. Food and Drug Administration now is in the North Carolina state Senate after unanimously passing the House last week.

VIZIENT, INC.: Expresses Concern with FDA Policy on Naming of Biologic Medications

Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.

Reforms could tackle high prices imposed by pharmaceutical industry

Whistleblowers are claiming that pharmaceutical companies are bribing doctors to sell their drugs so they can raise the prices on them.

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women

REGIS TECHNOLOGIES: Regis Technologies' 2019 FDA Inspection Yields NAI Classification (Zero 483s)

Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection.

FDA Reporter