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.

FDA to unveil new warning labels for cigarettes

The U.S. Food and Drug Administration is planning on unveiling a new rule where they will implement new health warnings in regard to cigarette packages.

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

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.

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.

Jeff Berg Assumes Top Leadership Role at AbelsonTaylor With Appointment to President

Founder Dale Taylor Will Remain CEO and Chairman of the Board

Some flavored e-liquid and hookah tobacco products to be removed

Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.

Dynacure receives orphan drug designation for drug to treat Centronuclear Myopathies

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

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.

FDA Update: electronic submissions statistics

Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.

Drug-patent reform seeks accessibility, less data

As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.

Republicans look to Fair Care Act of 2019 to improve health insurance system

Some in Congress are hoping the Republican sponsored Fair Care Act of 2019 will open the floodgates for Americans to buy health insurance.

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.

FDA Reporter