MedTech Spectrum

Article Name Regulatory

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Patients implanted with the Evoke® System now eligible for full-body MRI scans

27th September, 2023

Qure.ai receives 510(k) FDA clearance for chest X-ray solution for Pneumothorax and Pleural Effusion

A monumental step towards getting healthcare AI to augment critical care and emergency care

18th September, 2023

Genesis MedTech Introduces China's First NPMA-Approved Antibacterial Sutures

Genesis MedTech, a leading medical device company, announced that its absorbable sutures with antibacterial protection have successfully obtained approval from the China's National Medical Products Administration (NMPA) for market release.

12th September, 2023

Alveofit receives US FDA clearance for alveoair spirometer

Marking a significant advancement in respiratory care

11th September, 2023

"We are coming up with CoEs for health science & medical devices": Priyank Kharge

Priyank Kharge, Minster for IT BT, Government of Karnataka speaking at the Global Innovation Alliance (GIA) Partners Meet held on August 28, 2023 in Bangalore

07th September, 2023

Bio-Gate AG signs LOI with North American medical device manufacturer for trauma implants

Bio-Gate AG (ISIN DE000BGAG981), a leading provider of innovative technologies and individual solutions for health and hygiene, has concluded a preliminary agreement (LOI, Letter-of-Intent) with a North American medical device manufacturer focusing on the trauma sector. The medical device manufacturer intends to use Bio-Gate's "HyProtectTM " coating process for its own implants in human medicine following the FDA approval process.

22nd August, 2023

CathVision's AI EP Recording System Gains FDA Clearance for Cardiac Ablation Success Measurement

ECGenius System with CARDIALYTICS Algorithms Provides Unprecedented Levels of Automated Analyses Derived from High-Fidelity, Low-Noise Cardiac Signals

16th August, 2023

CareBand Obtains US Patent for IoT Wearable System Safeguarding Vulnerable Individual

CareBand, a pioneer in low-powered location-based health and safety wearable solutions, celebrates the granting of US Patent No 11,714,197. This milestone further strengthens CareBand's position as a leading innovator in the rapidly growing LPWAN market.

16th August, 2023

Mirxes receives US FDA’s breakthrough device designation for blood-based cancer detection test

GASTROClear is the first miRNA blood test and the first gastric cancer molecular test globally to receive FDA Breakthrough Device Designation

14th August, 2023

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems

10th August, 2023

Medcrypt Unveils FDA Cybersecurity Readiness Services for Med Device Firms

With Medcrypt's FDA Cybersecurity Readiness Services, MDMs can confidently navigate mandatory eSTAR for 510(k) submissions and the FDA's upcoming Cybersecurity Refuse To Accept Policy for other submission types, benefiting from a mock submission process with expert feedback and review.

10th August, 2023

Ten stakeholders jointly seek recall of India's New Drugs, Cosmetics & Medical Devices Bill 2023

Indian medical device manufacturers, patient interest groups, users and hospitals write to Union Health Minister Dr Mansukh L Mandaviya

07th August, 2023

India launches first indigenously developed Magnetic Resonance Imaging (MRI) Scanner

Voxelgrids Innovations has developed the MRI Scanner under the National Biopharma Mission of Department of Biotechnology

07th August, 2023

Singapore unveils Industry Transformation Map 2025 for healthcare

Renewing focus on primary and preventive health in medical training

04th August, 2023

A dispute between industry & government's opinion on medtech sector?

Unfortunate to see PM’s ‘Make in India’ dream being bulldozed: AiMeD

01st August, 2023

icotec ag's VADER® Pedicle System Navigated Instruments Gain FDA 510(k) Clearance for Safer Spinal Implantation

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants.

28th July, 2023

RIVANNA Secures $30.5M from BARDA to Advance Accuro XV Musculoskeletal Imaging

Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software.

28th July, 2023

Beckman Coulter's DxC 500 AU Chemistry Analyzer Receives FDA Clearance

Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to optimize laboratory workflows and support critical clinical decisions.

26th July, 2023