Regulatory

INVO Receives 510(k) FDA Clearance for Expanded Use of the INVOcell Device

INVO Bioscience, Inc. (Nasdaq: INVO) ("INVO" or the "Company"), a commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the intravaginal culture ("IVC") procedure it enables, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the labeling on the INVOcell device and its indication for use to provide for a 5-day incubation period. The data supporting the expanded 5-day inc...

ATCOR Medical Partners with Datacubed Health to Enhance Patient Engagement in Decentralized Clinical Trials

ATCOR and Datacubed Health partner on a novel remote trial solution to integrate digital vascular biomarker patient monitoring within the Datacubed Health Patient Engagement Platform...

CXR-AID, Powered by Lunit, Approved for Reimbursement in Japan, Boosting Market Growth

Medical AI solutions, including CXR-AID, officially included in Japanese health insurance reimbursement as a management service fee of imaging diagnosis...

Blood safety and availability

Blood transfusion saves lives and improves health, but many patients requiring transfusion do not have timely access to safe blood. Providing safe and adequate blood should be an integral part of every country’s national health care policy and infrastructure....

FDA Approves ImageBiopsy Labs' AI Software for Comprehensive Long Leg Radiograph Measurements

- ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays. The company previously FDA-cleared its IB Lab KOALA Knee-Osteoarthritis Labeling Assistant and intends to expand to the US with further MSK-focused software solutions....

8th edition of International Conference on 'India Pharma & India Medical Device 2023' to open in Delhi

To promote India as a Manufacturing hub of quality medical products in the Pharmaceutical and Medical Devices Sector...

Medtech firm Translumina bolsters German presence with acquisition of Lamed GmbH

To excel in interventional cardiology, peripheral vascular, and structural heart disease segments...

Elekta Unity MR Linac to revolutionize cancer care in India

Merger of the power of MRI with the precise linear accelerator in a single unit...

Fujifilm India redefines healthcare with new service and support app

One of the revolutionary innovations introduced as a mobile service and support application...