Latest in Medical Devices

Medac and chiron develop organ-on chip tech for animal free drug testing

The companies aim to develop an animal-free pharmaceutical testing method that utilises organ-on chip technology, and will be used in rheumatoid arthritis drug testing

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Transmission Raman Spectroscopy - access the webinar series today

Offering significant advantages for bulk, quantitative and non-destructive analysis, Transmission Raman Spectroscopy is a preferred choice for applications where surface...
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Bespak and Orbia Fluor & Energy Materials partner to create climate-friendly inhalers

The two companies will create pMDIs with an optimised sustainability profile with Orbia's low global warming potential (GWP) propellant, Zephex 152a

BD and Ypsomed join forces to advance patient-centric, self-administering injectables

The companies will work together to create a subcutaneous autoinjector, which will be optimised to effectively deliver highly viscous biologic drugs

Johnson & Johnson completes V-Wave acquisition to support patients with heart failure

The strategic acquisition will bolster the pharma giant's MedTech offerings for patients with cardiovascular disease

Nipro begins $398m break into the US market with a new medical device production facility

The North Carolina facility will allow Nipro to better serve US customers, while also creating 232 jobs for the local area

The impact of ISO 13485 on medical battery manufacturing

ISO 13485 is an internationally recognised standard that sets out the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices. Daniel Gardiner, Quality Manager at Alexander Battery Technologies, reports

Carthera's carboplatin receives Orphan Drug Designation for use in malignant glioma

The combination of carboplatin with SonoCloud, an ultrasound technology designed to open the blood brain barrier, could show high potential for treating patients with malignant glioma

BioWin and MEDVIA sign first strategic collaboration between health clusters in Wallonia and Flanders

Agreement will leverage strengths of two powerhouses dedicated to health to foster cross-border collaboration, building critical mass and consolidating sector to maintain Belgium’s position as a leader in Europe’s healthcare industry

Novel innovation enhances productivity and output for Polish pharma company

A consultative approach to service, delivery and problem solving ensured that a Polish pharmaceutical company received the equipment and technology it needed to ramp up production and expand into new geographies

Latest posts in Medical Devices

FDA releases guidance to clarify guidelines for 'remanufacturing' devices that need maintenance or repair

The guidelines includes information on reusable product labelling, what it classifies as 'remanufacturing' and how companies can ensure products follow guidelines after multiple uses

Sharp announces Pennsylvania expansion to bolster growth in the sterile injectable market

The company will increase its capacity for secondary packaging activities, increasing its global footprint and US presence

Janssen to adopt Johnson & Johnson brand as the company celebrates 100 years of UK operation

The company's pharmaceutical and medical technology segments will combine under the Johnson & Johnson brand name in the UK

The key role of IVDs in healthcare: challenges to commercialisation and access

In simple terms, in vitro diagnostic (IVD) tests are done on samples such as blood or tissue that have been taken from the human body. IVDs can detect diseases, conditions and infections, provide patients with a better understanding of their ailment and how it might be managed and changed with treatment

Johnson Matthey agrees to sell Medical Device Components business

The business has been sold to Montagu Private Equity for USD $700m

Perimed AB collaborates with Serendipity Partners to accelerate growth

Serendipity Partners has acquired a 49% ownership stake in Perimed AB, signifying a strategic partnership encouraging expansion of the company and its products

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come

Refining test methods for a new generation of nasal drug products

The nasal drug product market is currently the focus of considerable research activity. Nasal sprays for local action, such as the treatment of illnesses including allergic rhinitis and hay fever, dominate in terms of market volume and are an important target for generic manufacturers, report Anna Sipitanou, Business Development Manager, and Mark Copley, CEO, Copley Scientific

On your UKCA mark, get set, go!

The world of medical device regulation has undergone unprecedented change in recent years. The impact of Brexit has added to this load, as manufacturers will need to allocate time and resources to negotiate this new compliance challenge, advises Ed Ball, Senior Associate, RQM+

Safety and sustainability in medical device manufacturing

Environmental sustainability is rapidly becoming a key item on the medical device manufacturer’s corporate agenda, reports George I’ons, Head of Product Strategy and Insights, Owen Mumford Pharmaceutical Services

The business and patient case for drug delivery device innovation in biosimilar products

Biosimilar development in the United States is at an important juncture, reports Darren Mansell, Regulatory Affairs Manager, Owen Mumford

ISO certifies Wasdell Ireland facility for medical device manufacturing

Wasdell Ireland facility has been certified ISO 13485 for medical devices

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IMed Consultancy shares IVD tips as the EU deadline for Class D devices draws closer

The whitepaper will analyse the role of in-vitro diagnostics (IVDs) in supporting healthcare systems with early disease diagnosis

Gerresheimer and Midas Pharma announce strategic partnership

The joint project comprises the development and marketing of the new generation autoinjector

Beckman Coulter launches its SARS-CoV-2 IgM antibody test

The test offers high accuracy crucial to reliably determine if a person has been exposed to the virus and if the patient has developed antibodies

NSF launches new IVD app

This free app is full of useful resources, perfect for any IVD professional on the go

FPS develops safety box for swabbing

The cabins are easily transportable and, once positioned in strategic points, will allow doctors to perform between 12 and 15 swabs in one hour

Safe’n’Sound Hulio pre-filled syringe launches in Europe

Safe’n’Sound, the passive safety device platform, is on the market in Europe with a newly registered injectable medication

Schott introduces COC polymer syringe designed for cosmetic and medical applications

The syringes are equipped with ergonomic container components to simplify and relieve the injection process

Pharmaseal launches new Clinical Trial Management System

Engility clinical trial management system has been launched and is the first product to be released from the Engility B2B platform

Consort Medical backs Mylan in FDA approval for generic version of Advair

British CDMO has built a 5,500 sqm dedicated cleanroom at its King’s Lynn site to support production of the dry powder inhaler

PHARMINTECH 2019: Pharmintech Monitor offers an outlook on the future of Life Sciences

Pharmintech Monitor has been developed to provide a broad and documented overview and to offer interesting insights and forecasts for the world of Life Sciences

FDA milestone for Biom’up

The surgical hemostasis specialist company announces the submission of an application to the FDA and the renewal of supply agreement

Wickham Labs to exhibit at Medical Technology Ireland 2018

The pharmaceutical and medical device contract tester will be located on the Millennium Stand 301 at the conference