The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD Alaris pumps recalled over keypad problems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agnovos Healthcare, Canon Medical, Contego Medical, Deephealth.
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
The FDA has finalized a 2018 draft rule that excludes several digital products from the definition of a medical device, a list that includes medical device data systems (MDDS) used in hospitals. The rule responds to requirements spelled out in the 21st Century Cures Act, which was signed into law in late 2016, making this a project of nearly five years’ duration on the FDA’s part.
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qorvo, Seigla.
Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).
TORONTO – For Scott Kadwell, president of Markham, Ontario-based RSK Medical Inc., the distributor tagged to sell the Health Canada approved Gammacore Sapphire, the device represents “a shift from a business to business to a direct-to-consumer business model.” For Rockaway, N.J.’s Electrocore Inc. which developed the self-administered technology, it’s one more regulator to have greenlighted the FDA cleared, CE-marked device for treating intractable migraine and cluster headache.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reverses HHS premarket notification exemptions; ITC will check findings for Zimmer/Heraeus dispute.
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