Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airamed, Inbrain Neuroelectronics, Natural Cycles, Spectrawave, T2 Biosystems, Tasso.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B.Braun, Cerevasc, Vonco, Ossdsign.
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
Insightec Ltd. broadened its CE mark approval for the Exablate Neuro, a focused ultrasound platform which treats essential tremors, to allow patients to have their second side treated. With some 60 million people estimated to be affected by essential tremor globally, Insightec hopes that with both sides treated, patients will have full body relief from tremor and therefore be able to resume everyday activities.
The U.S. FDA has broken out of the summer guidance doldrums in fine form, inking a series of nine draft and final guidances in the first half of September alone. The latest bolus includes a revised version of a guidance for the breakthrough devices program and two draft guidances for devices for weight loss, giving industry plenty to mull over as the final days of fiscal year 2023 trickle away.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Smartcardia.
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Attune Medical, Beacon Biosignals, Venus Concept.
China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annalise.ai, Corvista.
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