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Medical Devices

Digital therapeutics startup Respiree™ receives FDA clearance for RS001 cardio-respiratory wearable."

Illustrative Image of Respiree™’s RS001 Cardio-respiratory Wearable The RS001 is a chest wearable that measures respiration directly and c...

March 09, 2023 | News

First Integrated Table Motion for the da Vinci Xi Surgical System appears at Device Technologies Asia Training Center

Developed jointly by Baxter and Intuitive, the TS7000dV Surgical Table, an integrated table motion (ITM) for the Da Vinci Xi Surgical System, is currently ...

February 13, 2023 | News

Olympus Awarded Vizient Contract for Smoke Evacuation Portfolio

Surgical smoke can contain bioaerosols, viruses and chemicals, some of which are known carcinogens, and is potentially dangerous to operating room (OR) sta...

February 03, 2023 | News

Vision Research Supplies Embedded Phantom High-Speed Camera for Use With FDA-Cleared Sepsis Test

The device, Cytovale®’s IntelliSep® test, is a new diagnostic tool that provides clinicians with early indication of sepsis probability to su...

January 31, 2023 | News

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

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