Stimlabs LLC has taken a new view of wound healing by developing a fenestrated dehydrated complete human placental membrane allograft for chronic and acute wounds. The fenestration in the Release product allows fluids to drain away from the wound, promoting faster healing, while the tissue provides protection.
The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation.
Medtronic plc presented 10-year results from its ongoing trial comparing transcatheter aortic valve implantation with surgical aortic valve replacement. The results support use of the Medtronic Corevalve platform for lower risk of severe valve deterioration compared to surgical replacement.
Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that occur after mild traumatic brain injury such as headaches, dizziness and problems with concentration and memory.
Aion Biosystems Inc. may be operating at a fever pitch right now, with FDA 510(k) clearance in hand for the company’s Itempshield device, which provides continuous measurement of body temperature. The company is targeting use of the quarter-sized device for patients with cancer and individuals in long-term care.
Babson Diagnostics Inc. has line of sight for the commercial launch of its Betterway blood testing ecosystem, which is a less invasive way of taking blood and requires only one-tenth of the sample volume of venipuncture without sacrificing quality or accuracy. The company said that once the collection device developed in partnership with Becton Dickinson & Co. (BD) is cleared by the U.S. FDA, Betterway will be launched in Texas, where it already has established partnerships with retailers and where its commercial lab is up and running. In addition, Babson has fully validated a broad set of miniaturized assays that are ready for commercial processing in its CLIA-certified, CAP accredited laboratory.
Theken Companies LLC reported the acquisition of Visionair Solutions Inc. from the Cleveland Clinic, a deal that adds pulmonary therapy to its broad portfolio with Visionair’s 3D platform for the creation of silicon stents for central airway obstructions (CAOs). Terms of the transaction, which has officially closed, were not disclosed.
Two papers published in Nature on Aug. 23, 2023, describe brain computer interfaces (BCI) with unprecedented capabilities for decoding brain activity into sentences, translating at speeds around half that of normal speech, and with vocabularies exceeding 1,000 words.
Abcam plc closed out a three-month whirlwind of activity on August 28 with an agreement to sell the medical consumables company to Danaher Corp. for a purchase price of $24 per share in cash, a 2.7% premium over the previous closing price, and assumption of approximately $200 million in debt. The deal, which has an enterprise value of $5.7 billion, is expected to close in mid-2024.
The U.S. FDA has given Aquedeon Medical Inc. the green light to conduct an IDE clinical trial of its Duett vascular graft system. The device is designed to improve outcomes in surgical thoracic aortic procedures by simplifying treatment of target vessels and reducing overall procedure time.
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