Federal Food, Drug, and Cosmetic Act

MedReg 2023: Annual Medical Device Regulatory Confex - Navigating Regulatory Horizons

Retrieved on: 
Tuesday, August 15, 2023

DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that promises to revolutionize attendees' understanding of medical device regulations.
  • A compelling picture is painted by envisioning a world where medical device regulations are overlooked - a world that compromises patient safety.
  • MedReg 2023 transcends traditional learning, offering an experience designed to excite, inspire, and invigorate attendees' regulatory spirit.

MedReg 2023: Annual Medical Device Regulatory Confex - Where Regulatory Excellence Meets Virtual Engagement - ResearchAndMarkets.com

Retrieved on: 
Friday, August 11, 2023

The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that will revolutionize your understanding of medical device regulations.
  • Why should you make MedReg 2023 a priority on your virtual event calendar?
  • Imagine a world where medical device regulations are disregarded-a world where patient safety is compromised.

Sientra Reports Record Second Quarter Financial and Operational Results

Retrieved on: 
Thursday, August 10, 2023

IRVINE, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a surgical aesthetics company developing the safest and most innovative solutions for the best aesthetic outcomes, today announced its financial results for the second quarter that ended June 30, 2023.

Key Points: 
  • IRVINE, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a surgical aesthetics company developing the safest and most innovative solutions for the best aesthetic outcomes, today announced its financial results for the second quarter that ended June 30, 2023.
  • Twelfth consecutive quarter of year-over-year growth, with net sales of $23.1 million representing growth of 7.5% over the second quarter of 2022.
  • Sientra will hold a conference call today, August 10, 2023, at 4:30 pm ET to discuss second quarter 2023 results.
  • These non-GAAP financial measures should not be considered in isolation or as a substitute for U.S. GAAP financial measures.

Medcrypt launches new FDA Cybersecurity Readiness Services to prepare medical device manufacturers for upcoming changes to regulations

Retrieved on: 
Wednesday, August 9, 2023

SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness Services" empowering medical device manufacturers (MDMs) to confidently navigate the U.S. Food and Drug Administration's (FDA) Refuse to Accept (RTA) policy as well as the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023.

Key Points: 
  • SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Medcrypt, Inc. , the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness Services" empowering medical device manufacturers (MDMs) to confidently navigate the U.S. Food and Drug Administration's (FDA) Refuse to Accept (RTA) policy as well as the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023 .
  • "We developed the FDA Cybersecurity Readiness Services to address the growing demand from medical device manufacturers seeking guidance through the complex and evolving submission process.
  • Interested in ensuring your medical devices comply with FDA cybersecurity expectations (both requirements per the Act and recommendations per cybersecurity guidance)?
  • Inquire with Medcrypt to learn more about our FDA Cybersecurity Readiness Services, designed to guide medical device manufacturers through the new 510(k) eSTAR submission requirement and the cybersecurity Refuse to Accept (RTA) policy and streamline the path to regulatory approval.

GENIXUS Announces Launch of KinetiXTM Rocuronium Bromide Injection 5mL & 10mL Ready-to-Administer Syringes

Retrieved on: 
Thursday, August 3, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230803139911/en/
    KinetiX Propofol & Rocuronium Bromide Injection RTA Syringes.
  • KinetiX Rocuronium Bromide Injection possesses several key attributes inherent in the KinetiX platform:
    GENIXUS' Chief Commercial Officer (CCO), Seth Coombs , emphasized the company's determination to accelerate the launch of Rocuronium Bromide Injection to address the ongoing, and expected worsening, of shortages in the US market.
  • If rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide injection and drugs for which incompatibility with rocuronium bromide injection has been demonstrated or for which compatibility with rocuronium bromide injection has not been established.
  • Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.

Four Renowned Spine Surgeons Perform 3D Navigated Surgery with the PathKeeper System

Retrieved on: 
Thursday, August 3, 2023

KFAR SABA, Israel, Aug. 3, 2023 /PRNewswire/ -- PathKeeper Surgical, a privately-held, Israel-based medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to any patient in all operating rooms, reports that four renowned spine surgeons utilized the PathKeeper 3D optical navigation system during spinal fusion surgery at St. Vincent's Medical Center in Bridgeport, CT.

Key Points: 
  • "We are proud to deliver the PathKeeper 3D optical navigation system to the United States surgical community.
  • The PathKeeper system provides spine surgeons with a comprehensive 3D plan prior to the surgery, and a seamless execution of the surgical plan in the operating room," said Ryan LeBlanc, Chief Commercial Officer, PathKeeper Surgical.
  • PathKeeper Surgical received its FDA 510k clearance earlier this year for the PathKeeper system.
  • The name PathKeeper effectively describes the essence of the system — a 3D optical navigation system that 'keeps' the surgical 'path' on course throughout the surgery.

EOSOLUTIONS CORP. UNVEILS THE THINLINE SHEATH 510k SUBMISSION: A GROUNDBREAKING ADVANCEMENT IN VASCULAR ACCESS, COMBINED WITH DR. BANNER FOR UNMATCHED 8F ACCESS

Retrieved on: 
Wednesday, August 2, 2023

The Thinline Sheath redefines vascular access by offering a slim, low-profile design that facilitates smooth percutaneous introduction of compatible devices.

Key Points: 
  • The Thinline Sheath redefines vascular access by offering a slim, low-profile design that facilitates smooth percutaneous introduction of compatible devices.
  • Banner BGC with the ThinLine Sheath, we have created an exceptional 8 Fr system, making the best-in-class .091 in ID Dr.
  • Banner, the Thinline Sheath empowers physicians to perform complex endovascular procedures with unmatched confidence and precision.
  • This integrated solution further solidifies EOSolutions Corp.'s dedication to delivering high-quality complex catheter solutions that push the boundaries of medical innovation.

Nexus Pharmaceuticals Receives FDA Approval for Sterile Water for Injection, USP

Retrieved on: 
Monday, July 24, 2023

Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials.

Key Points: 
  • Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials.
  • According to the FDA and the FD&C (Federal Food, Drug, and Cosmetic) Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sterile Water for Injection USP, of Hospira, Inc.
  • Furthermore, the FDA has granted CGT (competitive generic therapy) designation for the 20mL presentation of sterile water for injection.
  • “The approval of this product is an important step in continuing our efforts to alleviate drug shortages and bring pharmaceutical manufacturing back to the U.S.”
    Nexus Pharmaceuticals’ Sterile Water for Injection will be available in cartons of 25 vials.

PaxMedica Announces Positive Top Line Results from the PAX-101 (intravenous suramin) Phase 3 African Sleeping Sickness Study, PAX-HAT-301

Retrieved on: 
Monday, July 24, 2023

These records included data from a few weeks of hospitalization while they were being evaluated and the diagnosis of TBR HAT confirmed.

Key Points: 
  • These records included data from a few weeks of hospitalization while they were being evaluated and the diagnosis of TBR HAT confirmed.
  • As their conditions began to deteriorate, patients were often treated with arsenic or related compounds, sent to a Sleeping Sickness Hospital, or sent home to die with their families.
  • The natural history records do not include long term outcomes data for many of the patients.
  • One suramin-treated patient tested positive for HIV (only 23% tested) and 16/76 (21%) of patients tested were positive for malaria.

Positron Corporation Enters New Manufacturing & Components Supplier Cooperative with Neusoft Medical Systems Subsidiary for New PET-CT Device

Retrieved on: 
Friday, July 21, 2023

Niagara Falls, NY, July 21, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company has entered an Novation Agreement with Shenyang Intelligent Neuclear Medical Technology Co, LTD (Intelligent Neuclear Medical), a wholly owned subsidiary of Neusoft Medical Systems (Neusoft), that transfers the original Business Cooperation Agreement between Positron and Neusoft Medical Systems (“Neusoft”) to now include Neusoft’s subsidiary, Intelligent Neuclear Medical.

Key Points: 
  • Niagara Falls, NY, July 21, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company has entered an Novation Agreement with Shenyang Intelligent Neuclear Medical Technology Co, LTD (Intelligent Neuclear Medical), a wholly owned subsidiary of Neusoft Medical Systems (Neusoft), that transfers the original Business Cooperation Agreement between Positron and Neusoft Medical Systems (“Neusoft”) to now include Neusoft’s subsidiary, Intelligent Neuclear Medical.
  • Positron has expanded its role as manufacturer with Intelligent Neuclear Medical designated as the Company’s contracted components supplier.
  • Positron’s classification as the device manufacturer is significant as it will register with the FDA as the applicant  of its FDA 510k submission for Medical Device Clearance for its Affinity PET-CT imaging device.
  • Neusoft formed Intelligent Neuclear Medical as a wholly owned subsidiary to segregate all Neusoft’s current nuclear projects and products, which also includes all nuclear R&D technology initiatives.