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International -
Amazon Is Building an All-Star Health Tech Team

Amazon has reportedly hooked a former FDA officer for its new healthcare business, but we still don't know much about this secretive new venture. Details about Amazon's ambitions in healthcare are still sparse at this point, but the online retail giant appears to be building an all-star team to lead the new venture. Earlier this year Amazon announced a partnership with Berkshire Hathaway and JPMorgan Chase to create a new venture aimed at lowering healthcare costs and improving quality for employees. The company is also reportedly looking to give traditional medical suppliers a run for their...

How to Keep Up with FDA’s Expanding UDI Requirements

September 2018 brings a new deadline. Here’s what medical device manufacturers need to do. Patient safety doesn’t just lie in the hands of doctors and nurses. Medical devices and surgical instruments also have a huge impact on the accuracy of diagnostics and the proper execution of treatment plans. The reliability of devices used to treat or diagnose patients can be a matter of life or death, and flaws might not become apparent until it’s too late. Traceability systems using unique product identifiers have proven to be a highly effective means of helping protect the public from faulty devices...

International -
Johnson & Johnson Could Pull Plug on LifeScan

Johnson & Johnson continues its exodus from the diabetes market and has received a $2.1B offer from Platinum Equity to acquire LifeScan. Johnson & Johnson is getting closer to exiting the diabetes market, as Platinum Equity has made an offer to acquire the New Brunswick, NJ-based firm’s LifeScan unit for $2.1 billion. LifeScan develops blood glucose monitoring products and earned $1.5 billion in revenue in 2017. During J&J's most recent earnings call, company executives pointed to both diabetes and orthopedics as two units that had lagging sales. “Orthopedics performance was below...

India -
New medical devices procurement guidelines propose to make 20-50% of components

The Department of Pharmaceuticals has proposed that domestically sourced components have to contribute to 25-50% of the cost of medical devices procured by the government, depending on the category of the device. A draft of the proposed guidelines, created to give preference to products made in India, has sought comments from all stakeholders by April 5. At the same time, the proposed guidelines lack measures to help the local industry grow and imposes conditions that may hurt the quality of medical devices procured through these tenders, claimed a lobby group of domestic firms in the sector...

Europe -
Un livre blanc gratuit pour se préparer à l’IVDR

Afin d’aider les industriels du DM de diagnostic in vitro à comprendre les changements imminents et la manière de se mettre en conformité, Maetrics a publié un livre blanc gratuit détaillant les étapes à suivre. Le 5 avril 2017, le Parlement européen a approuvé la nouvelle Réglementation des dispositifs médicaux de diagnostic in vitro de l’Union européenne (IVDR ou RDIV). Cette dernière a été publiée dans le Journal officiel de l'UE. Le nouveau règlement (2017/746), qui abroge la Directive 98/79/CE et la Décision de la Commission 2010/227/UE, aura une force juridique contraignante à travers l...

Europe -
What is the future of harmonized standards?

For national standards bodies, 2018 brings a big challenge as we aim to generate appropriate revisions of key standards that manufacturers use to show compliance to essential requirements. These harmonized standards include an Annex ZA/ZZ which represents the correlation between the requirements in the EU Medical Devices Directives (MDD, AIMD, IVDD) and the standard in question. Now that we are moving towards the EU Medical Devices Regulations EU 2017/745 and the IN-Vitro Diagnostic Regulation EU 2017-746 (MDR & IVDR), the technical committees are reviewing their portfolio to establish...

India -
Proposes caps on use of imported medical devices

India has proposed regulating the proportion of locally made and imported medical devices procured by public programs. The draft guidelines (PDF) called for at least 50% of some types of devices to come from Indian companies. Local companies gained preference over foreign businesses under Indian public procurement rules last year. But those general, pan-industry rules stopped short of stipulating how the “Make in India” promotional agenda would apply to the procurement of medical devices. A draft document released by the Department of Pharmaceuticals (DoP) has now filled that gap...

Découverte -
Stentrode : un implant pour que les paralysés remarchent

Mis au point à l'université de Melbourne, le dispositif permet de piloter un exosquelette ou de mouvoir des membres robotiques par la pensée. Robotiser son corps pour le bouger à nouveau par la force de la pensée, rêve ou réalité ? Selon FuturaTech , un implant développé à l'Université de Melbourne pourrait changer la vie des personnes paralysées . « Stentrode » est un ressort, similaire aux extenseurs vasculaires métalliques qui maintiennent les artères ouvertes pour prévenir des AVC ou des infarctus. Mais ce dispositif – de la taille d'une allumette ou d'un petit trombone – est équipé d'...

Europe -
EU MedTech Groups Seek Digital Health Sector Boost in Upcoming Budget Deal

Negotiations on the EU’s upcoming Multiannual Financial Framework (MFF) are nearing an inflection point and industry groups are arguing for aligned regulations and better funding for European health and care systems, according to a new joint paper. The European Commission is set to formally propose the next multi-year budget by early May 2018, pending stakeholder consultations on priorities from earlier this year, and the trade associations MedTech Europe and COCIR are pinpointing elements critical to growing the field of digital health. The funding of research, development, and innovation...

Industry Raises Concerns with FDA Draft Guidance on Clinical Decision Support Software

A draft guidance from the US Food and Drug Administration (FDA) on clinical and patient decision support software received a deluge of industry comments highlighting key issues and concerns. The draft document – issued December 2017 as part of the agency’s recently launched action plan to shift its regulatory approach on digital health products – provided initial interpretations on the scope of FDA oversight by identifying the types of functionalities that fall outside of the definition of a medical device, as amended by the 21 st Century Cures Act , and are exempt from certain compliance...



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