Article Name Regulatory

National Health Authority and Maharashtra University of Health Sciences sign MoU to drive digital health education

Providing comprehensive understanding of Digital Health fundamentals to doctors and healthcare providers

13th August, 2024


A new medical device design CDMO to open in Ireland's Galway

Establishing a hub for cutting-edge medical technologies

13th August, 2024


SMT gains classification in the Italian National CONSIP tender

To supply TAVI devices in all Italian hospitals

08th August, 2024


Pneuma Systems’ infusion technology accepted by FDA's Safer Technologies Program (STeP)

Highly selective program by FDA for accelerated regulatory review process

12th August, 2024


CroíValve announces $16 million equity financing for developing novel transcatheter tricuspid device

To fund study evaluating performance of device in severe tricuspid regurgitation patients

07th August, 2024


US FDA clearance for PENTAX Medical’s DEC Duodenoscope

Compatibility with Advanced Sterilization Products’ STERRAD 100NX sterilizer

05th August, 2024


Battelle to guide medical device companies through regulations on ‘forever chemicals’

Battelle has been developing innovative solutions to advance the testing, analysis and destruction of PFAS

29th July, 2024


SpotSee’s HemoTemp II receives standards accreditation from AABB

A step further in ensuring supply chain integrity for blood during transit and storage outside blood banks

25th July, 2024


Edwards Lifesciences announced it has entered into an agreement to acquire JenaValve

Peijia to maintain exclusive rights in Greater China to commercialize JenaValve's Trilogy Transcatheter Heart Valve (THV) System

25th July, 2024


AtriCure receives regulatory approval to sell AtriClip devices in China

AtriCure also plans to partner with leading medical institutions in China

23rd July, 2024


AiMeD hails Union Budget-2024; will give a boost to overall economic growth: Rajiv Nath

Medical devices industry was expecting more for quality and affordable healthcare: AiMeD Forum Coordinator Rajiv Nath

23rd July, 2024


MediTech Stackathon 2024 to Drive Explosive Growth

India's MedTech industry holds immense potential, with projections estimating a growth rate of 28 per cent annually, and hitting $50 billion by 2030. India is the fourth largest market for medical devices in Asia and among the top 20 globally. Net imports for 2022-23 stands at $4.101 billion with an import coverage ratio of 0.45. The sector has witnessed a surge in imports, driven primarily by countries like the US, China, and Germany, however, India's robust policy ecosystem presents opportunities for exports and reducing import dependence through domestic manufacturing. Exports have overtaken imports in consumables and disposables during the last year. The industry now needs to continue with the momentum in other pillars of the medtech sector. Against this promising backdrop, the Department of Pharmaceuticals rolled out MediTech Stackathon 2024, in a bid to harness the collective expertise of stakeholders to ultimately propel the industry towards unparalleled heights of innovation and self-reliance. Let’s explore how the Indian medtech industry is prepping for the big leap.

01st July, 2024


InnoVoyce Secures FDA Clearance for VYLO™ Laser System

Innovative 455nm blue light laser offers unparalleled precision and versatility for a wide range of surgical procedures, marking a significant milestone in medical technology.

31st May, 2024


Thermo Fisher Gains EU IVDR Compliance for CytoScan Dx Assay and ChAS Dx Software

New compliance ensures enhanced safety and efficacy for cytogenetic testing in the EU, advancing diagnostic capabilities.

31st May, 2024


IOTA Diagnostic receives CDSCO approval for cervical cancer screening test

M-Strip is an indigenously built novel advancement for cervical cancer screening

28th May, 2024


WHO approves largest number of regulatory agencies for medical products

Decision is based on the recommendation by the WHO technical advisory group

22nd May, 2024


UK Govt unveils AI Airlock to address challenges for regulating medical devices using AI

AI Airlock can enhance the relationship between developers and manufacturers

21st May, 2024


Exploring Japan's Healthcare Landscape, Opportunities, and Challenges at MEDICAL JAPAN TOKYO

Tokyo, Japan - Connecting Healthcare Innovators: Exploring New Opportunities at the Premier Medical Trade Show by RX Japan Ltd.

20th May, 2024


Medtech Special

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