Article Name Regulatory
IMed Consultancy Launches New UKRP-Focused Website for Medical Device Launches in the UK
IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services
05th July, 2023
SimonMed Imaging Implements 3rd Generation iCAD Breast AI 3.0
At no additional cost to patients
03rd July, 2023
Will Indian National Medical Policy Unleash Sector's Full Potential?
The National Medical Devices Policy, 2023 that got the approval of the government on April 26 seems to have made the medical devices sector happy. The slew of strategies mentioned in the policy assures a win–win outcome for the manufacturers as well as patients. Experts are upbeat about the projected growth of the sector in the near future. The policy aims to bring a range of interventions in a coherent manner that would facilitate focussed and efficient support and facilitation for the sector by the respective agencies. Let's explore further.
29th June, 2023
Indian Cabinet approves introduction of National Research Foundation Bill 2023 in Parliament
To strengthen the research ecosystem in the country
29th June, 2023
Roche Gets FDA Clearance for Additional Alzheimer's CSF Assays, Enhancing Diagnosis and Treatment Decisions
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Total-Tau CSF assays (tTau) have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42 ratio) measure two biomarkers of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.
28th June, 2023
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 incubation clearance demonstrated improved patient outcomes.
28th June, 2023
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
27th June, 2023
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
27th June, 2023
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.
26th June, 2023
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.
26th June, 2023
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
26th June, 2023
Medtech firm Translumina bolsters German presence with acquisition of Lamed GmbH
To excel in interventional cardiology, peripheral vascular, and structural heart disease segments
26th June, 2023
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
26th June, 2023
Fujifilm India redefines healthcare with new service and support app
One of the revolutionary innovations introduced as a mobile service and support application
19th June, 2023
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