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Tag: Medical Device Supply Chain

eCential Robotics and ChoiceSpine Announce Long-Term Partnership to Enhance Robotic Spine Implant Surgery

GIÈRES, GRENOBLE, France & KNOXVILLE, Tenn.--(BUSINESS WIRE)-- eCential Robotics, a French growth company that designs, manufactures, and markets the first unified 2D/3D robotic imaging...

Envoy Medical Receives FDA IDE Approval to Begin Early Feasibility Study of Acclaim® Cochlear Implant

The First-of-Its-Kind Fully Implanted Acclaim Cochlear Implant Received Breakthrough Device Designation WHITE BEAR LAKE, Minn.--(BUSINESS WIRE)-- Envoy Medical® Corporation, a hearing health company focused on...

BrainsWay Announces Positive OCD Coverage Policy from Blue Cross Blue Shield® (BCBS) Licensee Highmark BCBS for Deep TMS™

Highmark BCBS Covers 6.8 Million Members in Four States BURLINGTON, Mass. and JERUSALEM, June 21, 2022 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY)...

Petvivo Holdings, Inc. To Announce Results for the Year 2022 Ended March 31, 2022

MINNEAPOLIS, MN, US, June 21, 2022 (GLOBE NEWSWIRE) -- PetVivo Holdings, Inc. (NASDAQ: PETV and PETVW), an emerging biomedical device company focused on the...

SoniVie receives IDE approval from FDA for its Pilot study to treat Hypertension with its Renal Artery Denervation TIVUS™ technology

TEL AVIV, Israel, June 20, 2022 /PRNewswire/ -- SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS™) to treat a...

These Class III Devices Exempted for Clinical Trial: Cardio/Neurosurgery, Radiation, Imaging, Ophthalmology and More

NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical...

China NMPA Regulatory Submission Case Study: PET/CT System

We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical...

Conformal Medical Announces Launch of CONFORM Pivotal Trial

Study to support U.S. FDA approval of the novel CLAAS® implant forleft atrial appendage occlusion (LAAO) and stroke prevention NASHUA, N.H., June 17, 2022...

Automated Wearable Breast Ultrasound System: Interview with Maryam Ziaei, CEO of iSono Health

Automated Wearable Breast Ultrasound System: Interview with Maryam Ziaei, CEO of iSono Health | Medgadget Posting....

Self-Regulating Footwear for Diabetic Foot Issues

Self-Regulating Footwear for Diabetic Foot Issues | Medgadget Posting....

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