Diabetes is the first med-tech sphere that is coalescing for Verily Life Sciences LLC, but cardiology could be next. The South San Francisco-based business that’s part of Google parent Alphabet Inc. has received a second FDA clearance for its Verily Study Watch as an irregular pulse monitor. After a 2017 debut, it was first cleared by the agency about a year ago for use to take an on-demand electrocardiogram (ECG).
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.
Biointellisense Inc. received good news from the U.S. FDA, which gave its nod to the company’s Biosticker on-body sensor for scalable remote care. The Biosticker allows for continuous monitoring of vital signs and actionable insights, delivered to clinicians from patients in the home setting. The goal is to help in the early detection of potentially avoidable complications.
With four gene therapies already approved and more than 900 in development, the FDA has finalized six guidances and issued a draft guidance to clarify the rules of the road for developing and manufacturing the treatments.
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