National Medical Products Administration

Garmin introduces the GPSMAP 9000 series, the recreational marine market's largest chartplotters with 4K resolution

Retrieved on: 
Tuesday, September 12, 2023
Music, GPS, GRMN, Transducer, Life, Wrist, Electronics, Smartphone, Home, 9000, Temperature, National Medical Products Administration, MFD, HDCP, Radar, Control, Auto, IPS, Glass, NYSE, Social media, Satellite navigation device, Garmin, Newsroom

OLATHE, Kan., Sept. 12, 2023 /PRNewswire/ -- Garmin (NYSE: GRMN), the world's most innovative and recognized marine electronics manufacturer, today unveiled its flagship GPSMAP® 9000 chartplotter series designed for captains who demand the best. Available with 19", 22", 24" or 27" touchscreen displays, these all-in-one chartplotters offer stunning 4K resolution with edge-to-edge clarity, powered by a processor that's seven-times faster than previous generations. Thanks to the new Garmin BlueNet™ gigabit network, these premium multi-function displays (MFDs) provide comprehensive connectivity throughout the vessel with faster networking speeds than ever before.  

Key Points: 
  • Available with 19", 22", 24" or 27" touchscreen displays, these all-in-one chartplotters offer stunning 4K resolution with edge-to-edge clarity, powered by a processor that's seven-times faster than previous generations.
  • –Dan Bartel, Garmin Vice President of Global Consumer Sales
    The 4K resolution GPSMAP 9000 series delivers a seamless and luxurious modern look with a maximized glass design.
  • Utilizing Garmin's new BlueNet gigabit network, mariners can link the GPSMAP 9000 series with multiple chartplotters, cameras, radars, sonars and more at 10 times faster networking speeds.
  • Powered by BlueNet, the GPSMAP 9000 series offers enhanced multimedia streaming and seamless video integration, so onboard entertainment has never looked better.

Genesis MedTech introduces China's first domestic brand of NPMA-approved antibacterial sutures

Retrieved on: 
Tuesday, September 12, 2023
Triclosan, Suture, Staphylococcus, Staphylococcus epidermidis, Infection, MRSA, Gram-negative bacteria, Hospital-acquired infection, Staphylococcus aureus, CDC, MRSE, Patient, Risk, Korea Disease Control and Prevention Agency, Perioperative, National Medical Products Administration, Growth, Methicillin-resistant Staphylococcus aureus, WHO, JAMA Surgery, Lancet, NMPA, Genesis, Dis, World Health Organization, Pharmaceutical industry, Vaccine

The newly developed antibacterial sutures are coated with triclosan, a broad-spectrum antimicrobial agent with activity against gram-positive and gram-negative bacteria.

Key Points: 
  • The newly developed antibacterial sutures are coated with triclosan, a broad-spectrum antimicrobial agent with activity against gram-positive and gram-negative bacteria.
  • Alongside the highly anticipated absorbable antibacterial sutures, Genesis MedTech continues to expand its suture product lines with comprehensive offerings.
  • Furthermore, its barbed absorbable sutures with black needle, non-absorbable surgical polypropylene sutures, and controlled-release needle sutures have been widely used in thousands of hospitals nationwide.
  • Warren Wang, Chairman and CEO of Genesis MedTech Group, expressed his excitement stating, "We are thrilled to achieve this significant milestone as the first domestic brand in China to develop antibacterial sutures.

JL Audio Releases HTML Interface For Its MediaMaster® Source Units, Providing Complete Audio System Control From Popular MFDs

Retrieved on: 
Thursday, September 7, 2023
MFD, HTML, Electronic engineering, JL Audio, National Medical Products Administration, NMEA, Cassette tape, Online shopping

MIRAMAR, Fla., Sept. 7, 2023 /PRNewswire/ -- JL Audio, the leader in premium, high-performance marine audio systems, announced the release of its NMEA 2000 connected MediaMaster® HTML interface (MMA1-HTML). Compatible with the latest JL Audio MediaMaster® marine audio source units, including the MM105 and MM105-HR and all their compatible network controllers, the MMA1-HTML gives boaters full control of their JL Audio system, including all system features and settings, from onboard Simrad®, Lowrance® or Garmin® multifunction display (MFD).

Key Points: 
  • MIRAMAR, Fla., Sept. 7, 2023 /PRNewswire/ -- JL Audio , the leader in premium, high-performance marine audio systems, announced the release of its NMEA 2000 connected MediaMaster® HTML interface (MMA1-HTML).
  • Compatible with the latest JL Audio MediaMaster® marine audio source units, including the MM105 and MM105-HR and all their compatible network controllers, the MMA1-HTML gives boaters full control of their JL Audio system, including all system features and settings, from onboard Simrad®, Lowrance® or Garmin® multifunction display (MFD).
  • "Historically, MFDs provided limited compatibility and control for sound systems, which made having an audio system control head necessary.
  • The JL Audio MMA1-HTML is available immediately to boat manufacturers and will be featured in many 2023 model year vessels.

Anova Partners with Dizal (Jiangsu) Pharmaceuticals to Accelerate Development of DZD9008 for Patients with Advanced or Metastatic NSCLC with EGFR Exon20 insertion Mutation

Retrieved on: 
Wednesday, September 6, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Partnership, Therapy, Clinical trial, NDA, Cancer, Hope, Research, NSCLC, Patient, Physician, EGFR, National Medical Products Administration, Medicine, Enterprise, NMPA, Analysis of variance, Pharmaceutical industry

Dizal is a commercial-stage biopharmaceutical company focused on the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases.

Key Points: 
  • Dizal is a commercial-stage biopharmaceutical company focused on the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases.
  • Dizal are evaluating DZD9008 in a Phase III study in a first-line setting and a Phase II study in a recurrent setting.
  • EGFR Exon20ins occur in about 2% patients with NSCLC.
  • NSCLC patients with EGFR Exon20ins mutations can e-mail [email protected] to find out more about the study and consider participation.

Rapid Medical™ Gains Approval in China for the World’s Only Adjustable Thrombectomy Device

Retrieved on: 
Thursday, August 31, 2023
Research, Surgery, Medical Devices, Neurology, Biotechnology, Health, General Health, Other Science, Science, TIGER, Comparable, Stroke, Brain, Grand Rapids Medical Mile, MicroPort, Patient, Physician, Risk, National Medical Products Administration, Embolism, NMPA, Medical imaging

Rapid Medical™, a leading developer of advanced neurovascular devices, announced Chinese approval for its TIGERTRIEVER revascularization device.

Key Points: 
  • Rapid Medical™, a leading developer of advanced neurovascular devices, announced Chinese approval for its TIGERTRIEVER revascularization device.
  • With this milestone of National Medical Product Administration (NMPA) approval, TIGERTRIEVER becomes the first device to offer patient-specific solutions for removing blood clots from the brain to advance the treatment of ischemic stroke.
  • “This new approval for TIGERTRIEVER propels treatment for ischemic stroke patients in China,” says Ronen Eckhouse , co-founder and CEO at Rapid Medical.
  • Comparable, leading stent retrievers are self-expanding and static, which can lead to suboptimal clot removal and minimal vessel protection.

Peijia Medical Announces 2023 Interim Results

Retrieved on: 
Thursday, August 31, 2023
Technology transfer, Marketing, PRC, Stroke, Research, TVT, Hospital, Patient, Physician, TAVR, National Medical Products Administration, Growth, Aortic regurgitation, Bleeding, AR, NMPA, Aortic stenosis, Rare-earth element, Medical device, Pharmaceutical industry

HONG KONG, Aug 31, 2023 - (ACN Newswire) - Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, today announced financial results for the six months ended June 30, 2023 ("the period").

Key Points: 
  • HONG KONG, Aug 31, 2023 - (ACN Newswire) - Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, today announced financial results for the six months ended June 30, 2023 ("the period").
  • "In the first half of the year, the Company seized the opportunity to achieve significant growth through efficient product research and development and strong team execution," said Dr. Yi Zhang, Chairman and CEO of Peijia Medical.
  • Financial and Business Results by Segment:
    Transcatheter Valve Therapeutic ("TVT") Business:
    During the period, the TVT Business recorded revenue of RMB107.7 million, representing an increase of 106.8% period-over-period.
  • As of June 30, 2023, Peijia's distributor network covered approximately 2,100 hospitals in 31 provinces and municipalities in China.

Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China

Retrieved on: 
Wednesday, August 30, 2023
TKI, Policy, New Drug Application, NDA, Quality of life, Medicine, NSCLC, HKEX, Patient, NTRK, National Medical Products Administration, Breakthrough, CDE, Center for Drug Evaluation and Research, NMPA, TRK, Pharmaceutical industry

The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.

Key Points: 
  • The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.
  • “We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China.
  • Today’s recognition further supports repotrectinib as a potential first-in-class treatment for patients with NTRK-positive, TKI-pretreated solid tumors in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • Drugs granted Breakthrough Therapy Designations receive priority communications and guidance from the CDE to promote and expedite the drug development process.

HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer

Retrieved on: 
Tuesday, August 29, 2023
Adenocarcinoma, Independent Review Committee, AE, RECIST, Breakthrough therapy, PFS, Incidence, HKEX, Patient, GEJ, National Medical Products Administration, MET, Stomach, Safety, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.
  • The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer or GEJ adenocarcinoma patients with MET amplification.
  • Primary endpoint is objective response rate (“ORR”) evaluated by the Independent Review Committee (“IRC”) (RECIST 1.1).
  • Secondary endpoints include progression free survival (PFS) and incidence of various adverse events (AE), among others.

Bionano Announces Second OEM Partner has Received China NMPA Approval for DNA Extraction and Labeling Products for IVD Use of OGM in Reproductive Health

Retrieved on: 
Monday, August 28, 2023
DNA, Reproductive medicine, Pregnancy, Genomics, BMA, DLS, Doctor of Philosophy, Fertilisation, SAN, National Medical Products Administration, NPMA, IVD, OEM, OGM, NMPA, Medtech, Dietary supplement

A-smart is Bionano’s second Chinese OEM partner to obtain approval from NMPA for the Company’s optical genome mapping (OGM) solutions.

Key Points: 
  • A-smart is Bionano’s second Chinese OEM partner to obtain approval from NMPA for the Company’s optical genome mapping (OGM) solutions.
  • NMPA issued two approvals to A-smart: one for Bionano’s G2 direct label and stain (DLS) DNA labeling kit and one for Bionano’s G2 SP bone marrow aspirate (BMA) DNA isolation kit.
  • A-smart received IVD Class I labels, enabling these reagents to be used for in vitro diagnostics in China.
  • Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, “We want to congratulate A-smart, our second OEM partner to receive NPMA approval for our reagents.

Sisram Medical Announces First-Half 2023 Financial Results

Retrieved on: 
Wednesday, August 23, 2023
Opus, Alma, IBSA, Clinical trial, LMNT, Botulinum toxin, Pakistan Software Export Board, Dentist, Beauty, Acquisition, Patient, Physician, National Medical Products Administration, United Kingdom, Growth, Yoy, The Company, FDA, Health, Clothing, Pharmaceutical industry, Video game, Fine chemical, Retail, Medical device, Tourism

HONG KONG, Aug. 23, 2023 /PRNewswire/ -- Sisram Medical Ltd (the "Company" or "Sisram", 1696.HK; together with its subsidiaries collectively referred to as the "Group"), a global consumer wellness group, featuring a distinguished synergistic ecosystem of business building blocks and consumer-focused branding, including energy-based devices, injectables, aesthetics and digital dentistry, personal care, and more, today announced its unaudited consolidated interim results for the six months ended June 30, 2023 (the "Reporting Period").

Key Points: 
  • After consolidation, revenue from the Chinese energy-based device market is expected to grow significantly in H2 2023.
  • On a global scale, China serves as the pioneering market for Sisram Medical within the wellness ecosystem.
  • Mr. Liu Yi, Chairman and Executive Director of Sisram, commented: "Following the first half of 2023, we've achieved significant milestones in strategic deployment.
  • Mr. Lior Dayan, CEO of Sisram and Alma, said: "The first half of 2023 was pivotal for Sisram, as we continue our transition from a product-centered approach to a customer-centric approach and present significant achievements in building our unique wellness ecosystem.