Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

U.S. FDA: Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas, on measuring the progress being made through implementing the FDA Food Safety Modernization Act

FDA working to increase availability of Naloxone

The opioid crisis has become such a public health crisis that there is now a Prescription Opioid and Heroin Epidemic Awareness Week to focus on the dangers of opioid addiction as well as treatment options treatment – which includes access to Naloxone.

Vaping illnesses caused by illegal substances, AVA says

As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.

SIEMENS HEALTHINEERS: FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers

AI-based software enables automated enhanced visualization of CT images of the lungs, heart, and aorta

Critics say the latest attempt by Congress to reign in prescription drug prices may not work

The Prescription Drug Pricing Reduction Act (PDPRA) is expected to work its way through Congress this fall.

U.S. FDA: Continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program

FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway

Trump administration's flavored vaping ban doesn't go far enough, bipartisan group says

The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.

AVITA MEDICAL: Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction

First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction; study expected to commence within next 6 months

AETION: Former FDA Commissioner Scott Gottlieb Joins Aetion's Board of Directors

Gottlieb joins as Aetion advances real-world evidence for making drug development and commercialization more efficient

ZIMMER BIOMET: Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, has announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the JuggerStitch™ meniscal repair device.

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.

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.

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.

AVRA MEDICAL ROBOTICS: Initiates Food and Drug Administration Approval Process

AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an emerging growth company that is in the process of building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software; announced that its regulatory and management teams met with the Food and Drug Administration (FDA) on August 12th.

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

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.

FDA Reporter