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FDA grants pre-market approval to HLB Life Science’s disposable syringe
The US Food and Drug Administration (FDA) has granted pre-market approval (510K) to HLB Life Science ... the company is aiming to secure the Medical Device Single Audit Program (MDSAP ...
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Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
JD Supra4d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Mena FN1mon
Komodosec Streamlines FDA Approval For Medical Devices With Advanced Cybersecurity
Boaz Shunami, Co-CEO, KomodoSecNEW CASTLE, DE, UNITED STATES, December 12, 2024 /EINPresswire / -- KomodoSec Elevates Medical Device Cybersecurity, Facilitating Swift FDA 510(k) Approval KomodoSec ...
MedCity News4d
Supernus Wearable Device for Dosing Parkinson’s Drug Lands Long-Awaited FDA Approval
A new Supernus Pharmaceuticals medical ... regulatory approval were turned back by the FDA in 2022 and again last April, as the agency asked for more information about various aspects of the drug ...
Morningstar24d
Silver Bullet Therapeutics Announces FDA Approval of Pre-Market Study
Jan. 15, 2025 /PRNewswire/ -- Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that the Company now has approval to start a pre-market 510k study from the ...