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Medtech in a Minute: A Not-So-Hip FDA Warning, and More

Get up to speed on everything you might have missed last week, in one minute or less.

Amanda Pedersen

January 8, 2024

1 Min Read
Medtech in a Minute graphic
Graphic designed by MD+DI

A Not-So-Hip FDA Notice

Citing significant unapproved modifications, FDA is advising healthcare providers not to use Synovo Production’s Total Hip System. The system includes three components: the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing.

Philips Comes Under Fire Again

Philips Respironics is once more under fire for the handling of its respiratory device recall, this time due to the silicone foam used as a replacement to previous polyester-based polyurethane foam in recalled breathing devices. A new investigative report suggests the silicone foam used in the company's replacement sleep apnea machines emit dangerous chemicals.

Glaukos Wins a Long-Awaited FDA Nod

Glaukos won a nod from FDA for its iDose travoprost intracameral implant, indicated for use in patients with primary open-angle glaucoma or ocular hypertension. The company told MD+DI the 15-year journey to market required a submission that totaled more than a hundred-thousand pages.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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