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 MSN1d
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 ...
FDA approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
GlobalData on MSN4d
EssilorLuxottica wins FDA clearance and EU approval for OTC audio glasses
According to a 3 February press release, EssilorLuxottica received simultaneous clearance from the US Food and Drug ...
stockhead on MSN3d
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.
The Pharma Letter13h
China deepens comprehensive reform to strengthen drug, medical device regulation
China has issued a guideline on comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry, the National ...
JD Supra6h
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, ...
TheCable17h
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 ...
PathMaker Neurosystems Announces IRB Approval for DoD-funded Clinical Trial of the MyoRegulator Device in ALS
Nader Yaghoubi, M.D., Ph.D., PathMaker’s Co-Founder and CEO, stated, “We are pleased to announce IRB approval for the CALM study, which allows us to commence enrollments shortly. Given the mechanisms ...
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 ...
Backdoor uncovered in China-made patient monitors — Contec CMS8000 raises questions about healthcare device security
The CISA and FDA have released security warnings about the Contec CMS8000, which is used for patient monitoring.