International -
How to Succeed in the Diabetes Device Space

Diabetes presents a huge market for medical device makers, but challenges such as a tough competitive landscape and relatively low profit margins make it anything but a sure bet.

Last month, private equity firm Platinum Equity offered Johnson & Johnson $2.1 billion for J&J's LifeScan Inc. blood glucose monitoring unit. This comes after plans to shutter its Animas insulin pump subsidiary.

Although J&J plans to close the doors on its diabetes business, other companies thrive…or at least break even. Success in this competitive space takes flexibility, a commitment to the long game and a deeper commitment to the patients themselves.

Unfortunately, diabetes devices have plenty of potential customers. More than 100 million Americans now live with diabetes or prediabetes, and more than six million use insulin...

 

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Europe -
Harmonizing ISO 11607 with the EU's Medical Device Regulations

Revision of EN ISO 11607, the guiding standard for medical device packaging, is progressing toward completion later this year. With many of the changes prompted by EU’s new Medical Device Regulations (MDRs), could harmonization with the EU’s new law be next? ISO Technical Committee 198 Working Group 7 met earlier this year in Copenhagen to resolve comments received after ISO 11607’s Draft International Standard (DIS) document was balloted last year. The next step will be to finalize a Final Draft Standard (FDIS) for ISO Central Secretariat to review and then send out to ISO members for final...

USA -
FDA clears first contact lens with light-adaptive technology

The U.S. Food and Drug Administration today cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia). They can be used by people with certain degrees of astigmatism, an abnormal curvature of the eye. The National Eye Institute at the National Institutes of Health estimates that 42 percent of...

USA -
FDA Invokes Authority to Issue ‘Unique Type of Restriction’ on Essure Contraceptive Device

In a “unique type of restriction,” the US Food and Drug Administration (FDA) issued an order Monday to limit sales and distribution of Bayer’s permanent contraception device, Essure, over the numerous health risks that have been associated with its use. The decision is based on a “review of a growing body of evidence” that led FDA to conclude “previous efforts to alert women to the potential complication of Essure” have not been enough to ensure they receive “this important information,” FDA Commissioner Scott Gottlieb said in a statement. The birth control product, thus, “requires additional...

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