Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Imperative, Philips, Roche.
Following up on the $175 million it raised in September 2023, Avalyn Pharma Inc. secured an additional $100 million in an oversubscribed series D financing round to support development of its inhaled treatments for pulmonary fibrosis.
Five years after the COVID-19 pandemic virtually locked down the U.S. government and society in general, the Patent Trial and Appeal Board (PTAB) is shedding the last vestiges of those days.
Cooler Heads Care Inc. closed an oversubscribed series A, raising a cool $11 million for Amma, its portable scalp cooling system that reduces hair loss during chemotherapy. The new funds will facilitate expanded access to Amma, which is available to patients through infusion centers.
The U.S. organ donation system is once again under pressure from both the executive and legislative branches thanks to media reports detailing an instance in which a surgeon refused to harvest organs from a potential donor who had not expired.
Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.
The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.
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