Medtech Medical Devices

4 Medical Device Quality Trends for 2023

New guidance documents from regulators, a new approach to inspections, and cybersecurity risks all pose a challenge. The good news is th...

 January 21, 2023 | News

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Mass...

 January 16, 2023 | News

Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

Under the FDA's Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective tre...

 January 04, 2023 | News

Sonorous NV Uses New Device to Treat Patients with Symptomatic Cerebral Venous Diseases

The initial cases in North America were performed by Dr. Vitor Mendes Pereira, Neurosurgeon and the Director of Endovascular Research and In...

 December 19, 2022 | News

Medeologix Acquires Three Silicon Valley Medical Device CDMO Companies

Medeologix, a Taiwan MedTech CDMO company announces its successful acquisition of three premier medical device manufacturing companies to form an integrate...

 November 29, 2022 | News

GE Healthcare Introduces SIGNA Experience

GE Healthcare  announced the launch of SIGNA Experience, a platform of four synergistic technologies that help users through the diagnostic journey. T...

 November 28, 2022 | News

United Imaging Drives Forward Several Major Innovations in Multiple Imaging Modalities

United Imaging, a global leader in producing advanced medical imaging and radiotherapy equipment, announced a series of commercially available and 510...

 November 23, 2022 | News

Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified

  Lunit becomes first software as a medical device (SaMD) company in APAC to become MDR CE and UKCA certified MDR and UKCA certifications are requ...

 November 22, 2022 | News

BD, Biocorp Sign Agreement to Bring Connectivity, Traceability to Self-Administered Injectable Drugs

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Biocorp, a medical device and delivery systems m...

 October 18, 2022 | News

Industry Brief on 6 Key Capabilities of an eDHR System

        How to Tell If Your eDHR System Is Complete ...

 October 17, 2022 | Product Spotlight

Ascend continues broad expansion into new markets, launches HiDura™ MED portfolio

HiDura™ MED products meet ISO 10993-5 and 10993-10 testing criteria and can be used in a variety of healthcare applications, including: Medical du...

 October 12, 2022 | News

Topcon Introduces NW500 Non-Mydriatic Retinal Camera

Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, is pleased to announce that it has launc...

 October 07, 2022 | News

Olive Diagnostics Receives European CE Mark for its Cutting Edge AI-based Urine Analysis

Olive KG performs high quality analysis of important parameters in the patients' urine in each urination without user intervention. The user does nothing m...

 October 06, 2022 | News

Biotium’s New Laser Diode Gel Illuminator Offers a Superior Alternative to LED and UV-based Illumination

Biotium, a leading supplier and inventor of fluorescent tools for life science research, announces the release of the next-gene...

 October 06, 2022 | News


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