The FDA reported that the recall of the Arrow-Trerotola percutaneous thrombolytic device is a class I recall due to the risk of tip damage during use. This hazard could result in detachment of the tip from the device basket, which could damage or block vessels, a potentially lethal hazard for the patient.
PERTH, Australia – Nearly three-fourths of medical device stakeholders supported introducing mandatory reporting of medical device-related adverse events by health care facilities in Australia, but many raised concerns about data duplication and integrity.
After a rejection by the FDA in June, it looks like Orphazyme A/S is headed for disappointment in Europe too with arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition in which fat builds in tissues and organs. The Copenhagen-based company said it was summoned before experts to give an “oral explanation” about the drug, something that only occurs if the European Medicines Agency’s CHMP has developed major doubts during its review.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Chiesi, Mannkind, Orphazyme, Pfizer, Protalix, Rhythm, VBI.
The European Union’s (EU) Medical Device Coordination Group (MDCG) posted a guidance addressing verification of manufactured, high-risk in vitro diagnostics (IVDs), which indicates that manufacturers should submit samples to a reference lab for batch testing. However, the requirement for batch testing may not apply if no European reference lab has been designated for a test type, suggesting that some high-risk tests may go to market without adequate testing.
Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).
Neurosigma Inc. has received FDA breakthrough device designation for its Monarch ETNS system to treat drug-resistant epilepsy (DRE). The neuromodulation therapy uses noninvasive external trigeminal nerve stimulation (ETNS) to treat neurological and neuropsychiatric indications. The technology is currently commercialized for pediatric ADHD treatment.
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