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

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.