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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perimeter Medical Imaging AI.
The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS may reverse non-coverage for catheter pulmonary embolectomy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Oncosec Medical.
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