Saturday, August 24, 2019

Saturday, August 24, 2019

Latest News

New cloud-based vital signs measurement system approved by FDA

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

EDWARDS LIFE SCIENCES CORPORATION: Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients

Superior TAVR Valve Available for All Patients Diagnosed with Severe, Symptomatic Aortic Stenosis

NATIONAL KIDNEY FOUNDATION: IgA Nephropathy Patients Invited to Speak About their Disease to the FDA

National Kidney Foundation and IGAN Foundation of America organizing meeting to hear voices of patients with this chronic kidney disease

ABBVIE: Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).1 RINVOQ is expected to be available in the U.S. in late August 2019.

AESCULAP IMPLANT SYSTEMS, LLC: Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL® Artificial Disc Compared to Previous Generation Lumbar Discs

Aesculap Implant Systems, LLC, a leader in lumbar motion preservation technology, today announced the e-publication of the "Five-year results of a randomized controlled trial for lumbar artificial discs in single level degenerative disc disease" in Spine

EMPHYCORP INC.: FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis w/ No Known Side Effects

EmphyCorp Inc. www.EmphyCorp.com, a Private Corporation, is proud to announce the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its Orphan Drug Designations for the treatment of Interstitial Lung Diseases (ILD), which includes Pulmonary Fibrosis and Cystic Fibrosis.

CONCEPT MEDICAL INC.: Granted 2nd 'Breakthrough Device Designation' From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication

Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first 'Breakthrough Device Designation' received by Concept Medical Inc. was on 30th April 2019 for its MagicTouch SCB, for the treatment of Coronary Artery Disease (CAD) in patients with in-stent restenosis.

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

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.

NINEPOINT MEDICAL: Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System

NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE® Imaging System for use in the pancreas and bile duct.

GILEAD SCIENCES: Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration (FDA) recommended approval of Descovy®(emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men by a vote of 16 to 2.

NETFLEX: NextFlex’s Technology Hub Complies With FDA Standards for Manufacturing of Medical Devices

Adherence to FDA Quality Standards Will Boost Ability of Fabrication Facility to Produce Pilot-Scale Devices for NextFlex Members and Customers

NORD: Funded By FDA, C-Path And NORD To Launch Rare Disease Data Analytics Platform

The collaborative project between the organizations will kick off at a launch meeting in September and will aim to reduce barriers for the development of new treatments and cures for rare diseases

THERMO FISHER SCIENTIFIC: New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories

Thermo Scientific Medical Device portfolio provides an extensive range of chromatography and mass spectrometry instruments for performing laboratory developed tests

DALENT MEDICAL: Sinusleeve™ Balloon Device Completes FDA Listing, Dalent Medical Begins Sales In South Florida

Dalent Medical, a Miami-based company developing innovative devices for Ear, Nose & Throat Doctors is pleased to announce that the Sinusleeve™ Balloon Sinus Dilation Sleeve has completed the United States Food and Drug Administration's listing process.

INOTREM: Announces FDA Clearance of Investigational New Drug (IND) for the Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy

Inotrem S.A., a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for the ASTONISH trial (Phase IIb) where the safety, tolerance and efficacy of nangibotide (LR12), its lead compound for septic shock, will be studied.

FDA Reporter