Medical Devices

IIT-H announces Chair Professorship in medical devices, diagnostics

The Institute considers stalwarts in academics and industry for this chair professorship...

Pharma & Medical Devices Conference 2022 to draft plan for next 25 years

Health Minister Dr Mansukh Mandaviya inaugurates the 7th International conference on Pharma and Medical Devices sector...

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....

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...

Eko Health Launches CORE 500™ Digital Stethoscope with Heart Disease Detection AI and Advanced Features

Next-generation FDA-cleared medical device brings non-invasive heart and lung disease detection to healthcare professionals at the point of care ...

Sybleu Inc. Secures Exclusive License for AI/ML Small Molecule Drug Design Engine

SYBLEU INC. (OTC PINK: SYBE), a biotechnology company focused on therapies for human and animal health, medical devices, and clinical diagnostics, is preparing to begin advancing small molecule drug therapies for animal and human health....

Techsomed to Field Evaluate Image-Guided Ablation Software with GE Healthcare's LOGIQ™ Ultrasound Systems at Leading US Clinical Sites"

Techsomed Ltd., the developer of BioTrace, an AI powered software platform for real time ablation zone imaging and treatment precision enhancement....

CereVasc and LianMedical Partner to Bring Innovative eShunt® System to Asian Markets

Collaboration Bolsters LianMedical's Mission to Bring Novel Technologies to the Asian Market and Supports Global Expansion of CereVasc's Technology...

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...

SV Health Investors Completes Partnership with Packaging Compliance Labs

Founded in 2014, Packaging Compliance Labs is a leading sterile packaging center of excellence, providing comprehensive healthcare packaging solutions aimed to accelerate medical device and pharmaceutical product launches. PCL's extensive capabilities support customers in each step of packaging from the design phase to full-scale production. ...