MassDevice

Medtronic wins expanded FDA approval for OmniaSecure for conduction pacing

Medtronic (NYSE: MDT) announced today that it received FDA approval for an expanded indication for its OmniaSecure defibrillation lead.

FDA approves new higher-dose version of Wegovy shots

Federal regulators on Thursday approved a new higher-dose version of the blockbuster obesity drug Wegovy that may help users ...
HME News

LivaNova receives FDA premarket approval for CPAP alternative

LivaNova has announced that the U.S. Food & Drug Administration (FDA) has granted premarket approval (PMA) for the aura6000 System for the treatment of adult patients with moderate to severe obstructi ...

Rhythm's therapy becomes first FDA-approved treatment for brain damage-related obesity

By Sneha S K and Sahil Pandey March 20 (Reuters) - The U.S. Food and Drug Administration expanded the use of Rhythm ...
NBC News

FDA approves new use of synthetic vitamin B9 — but not for autism symptoms

The Food and Drug Administration on Tuesday announced a new approved use for the drug leucovorin, a synthetic form of vitamin B9 that the Trump administration has touted as a treatment for autism ...
Healio

FDA expands approval for setmelanotide to patients with hypothalamic obesity

The FDA has approved an expanded indication for setmelanotide to treat children and adults with acquired hypothalamic obesity ...

LivaNova eyes 2027 launch of neural sleep apnoea therapy after FDA approval

LivaNova's aura6000 system delivers synchronised electrical pulses to the hypoglossal nerve to prevent airways collapse in ...
AOL

What is leucovorin? FDA expands drug’s approved use but walks back autism claims

The Food and Drug Administration has approved a generic medication for a rare brain disorder while walking back suggestions by President Donald Trump and other administration officials that the drug ...
UPI

FDA approves leucovorin to treat rare cerebral folate deficiency

March 10 (UPI) --The Food and Drug Administration has approved expanded use of leucovorin calcium tablets for treating cerebral folate deficiency, a rare disorder. The vitamin, a synthetic form of ...
The Hill

FDA proposes new treatment approval pathway for ultrarare diseases

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...
AOL

What are the best FDA-approved male enhancement pills & products?

Ads for male enhancement supplements are everywhere. If you turn off your pop-up blocker for even a second, you’ll be bombarded with spots for “the best pills for men,“ “the best enlargement pills,“ ...
CNN

FDA approves leucovorin for rare genetic condition, but not for autism

The prescription drug leucovorin is getting a label update, but it’s not what that the US Food and Drug Administration suggested during a White House briefing in September, when officials touted the ...