The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers

AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
Medical Device and Diagnostic Industry (MD+DI)

CGM Manufacturer Views FDA’s New Rules on Wearables as “Catalyst” for Accelerated Commercialization

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.

FDA commissioner says non-medical-grade wearable data exempt from regulation

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health technology and AI policies.

FDA moves toward tougher gluten labeling rules

The FDA said that "serious data gaps" have hindered its ability to craft regulation, including a lack of information on ...
Targeted Oncology

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

US FDA to limit regulation of health and fitness wearables, commissioner says

By Puyaan Singh Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing ...
Healio

FDA grants breakthrough designation to ianalumab for Sjögren’s disease

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
PharmExec

FDA Limits Regulations on Non-Medical Grade Wearable Fitness Devices

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...
BioPharma Dive

FDA lays out new path to speed development of multiple myeloma drugs

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...
Becker's Hospital Review

FDA proposes new endpoints for multiple myeloma drug trials

The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...
MobiHealthNews

Should mHealth companies want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...