Device, drug makers seek tariff exemptions
Makers of drugs and medical devices say the tariffs on goods from Canada, Mexico and China could have an outsized impact on ...
GlobalData on MSN2d
Femasys gains approvals for infertility and diagnostic products in Israel
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Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.
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State Licensing Requirements: Are You Prepared?
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...
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Merit Medical Celebrates FDA Approval of WRAPSODY™
An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
JD Supra3h
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Alpha Tau announces FDA approval of IDE supplement
Medical announced an approval from the U.S. Food and Drug Administration, FDA, of an Investigational Device Exemption IDE, ...
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NAFDAC, African regulatory agencies sign MoU to speed up medicine approval
African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...
GlobalData on MSN9h
Senseonics files for Eversense 365 CE Mark registration
Senseonics has filed to obtain CE Mark registration for its one-year continuous glucose monitoring (CGM) system, Eversense 365. The CE Mark submission aligns with the EU Medical Device Regulation (MDR ...
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Avita Gets FDA Nod For Device
On Dec. 23, Avita received FDA approval for a version of the Recell device that treats small-scale wounds. According to the ...
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Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
The trial’s lead investigator, professor Daniel Claassen from Vanderbilt University Medical Centre ... EBR), which is ...
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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 ...