KP Biomedical Engineering - Issue #12

-CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare ARLINGTON, Va. & REYKJAVIK, Iceland--(BUSINESS WIRE)

--Kerecis, the pioneer in the use of fish skin and fatty acids for tissue regeneration and protection, announced Medicare coverage approval of two of its products by the U.S. Centers for Medicare & Medicaid Services (CMS) in a new Local Coverage Determination (LCD). This LCD focuses on skin substitutes for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in the Medicare population.

-Yamaha Motor Launches CELL HANDLER(TM) 2: New Cell Picking and Imaging System IWATA, Japan--(BUSINESS WIRE)

--Yamaha Motor Co., Ltd. (Tokyo: 7272) announced the upcoming release of the new CELL HANDLER(TM) 2, a cell picking and imaging system set to launch in March 2025. This advanced system aims to enhance the efficiency and refinement of research and experiments focused on new drug development. CELL HANDLER(TM) 2 is the successor to the CELL HANDLER(TM), a cell picking and imaging system that handles cells (clusters)*1 and acquires data with high speed and accuracy.

-Adagio Medical Reports Third Quarter 2024 Results LAGUNA HILLS, Calif.--(BUSINESS WIRE)

--Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company” or “Adagio”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, provided business updates for third quarter ended September 30, 2024. Recent Business Highlights: Reported total company revenue of $185 thousand in the third quarter of 2024, compared to $41 thousand in the third quarter of 2023.

-CalmiGo Named as CES Innovation Awards® 2025 Honoree NEW YORK--(BUSINESS WIRE)

--CalmiGo, developer of the first and only mental health platform that provides immediate relief and long-term care to users suffering from anxiety, PTSD, and panic attacks, announces it has been named a CES Innovation Awards® 2025 Honoree in the digital health category for CalmiGo Plus. The CES Innovation Awards® 2025 program received a record number of submissions – over 3400.

-Precision BioSciences Highlights Preclinical Data and Outlines Design of First-in-Human Clinical Trial for PBGENE-HBV for Treatment of Chronic Hepatitis B DURHAM, N.C.--(BUSINESS WIRE)

--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today will present preclinical data supporting the advancement of PBGENE-HBV into clinical development. The Company will also outline the design of its first-in-human study, ELIMINATE-B, in patients with chronic hepatitis B.

-Thermo Fisher Scientific Authorizes $4 Billion of Share Repurchases WALTHAM, Mass.--(BUSINESS WIRE)

--Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that its Board of Directors has authorized the repurchase of $4 billion of shares of its common stock in the open market or in negotiated transactions. The authorization has no expiration date. This replaces the company’s existing repurchase authorization, of which $1 billion was remaining.

-PCE Automation Acquires Olmec-UK BECCLES, England--(BUSINESS WIRE)

--Automation solutions provider, PCE Automation Ltd completes its second acquisition in just two years, with north Lincolnshire-based vision inspection and web conversion provider, Olmec-UK being the latest addition to its expanding portfolio. The acquisition was a strategic choice, allowing PCE Automation to strengthen its existing presence within the Life Science sector by bringing vision inspection and web conversion capabilities into its offering.

-DistillerSR Launches Industry’s First Purpose-built GenAI Solution for Literature Reviews BARCELONA, Spain--(BUSINESS WIRE)

--DistillerSR Inc., the market leader in AI-enabled literature review software and creator of DistillerSR®, announced the availability of Smart Evidence Extraction (SEE)™, the industry’s first purpose-built GenAI solution for literature reviews.

-BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations PARIS--(BUSINESS WIRE)

--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA 510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the fetal heart. This milestone marks a significant breakthrough in one of the most challenging and critical areas of prenatal care.

-Deep learning AI model outperforms humans in identifying pathologies

--A "deep learning" artificial intelligence model developed at Washington State University can identify pathology, or signs of disease, in images of animal and human tissue much faster, and often more accurately, than people.

-Teledermoscopy offers reliable skin cancer diagnosis

--Collecting images of suspicious-looking skin growths and sending them off-site for specialists to analyze is as accurate in identifying skin cancers as having a dermatologist examine them in person, a new study shows.

-New biosensor technology could revolutionize mpox diagnosis

--A new variant of human mpox has claimed the lives of approximately 5% of people with reported infections in the Democratic Republic of the Congo since 2023, many of them children. Since then, it has spread to several other countries.

-Futuristic AI-powered virtual lab designs potent SARS-CoV-2 nanobodies

AI-human collaboration in a "Virtual Lab" successfully designs and experimentally validates nanobodies with enhanced binding to SARS-CoV-2 variants, offering a novel approach to interdisciplinary research.

-Northern Ireland's laboratory services reach IT milestone

--Clinisys has announced the completion of phase three of the CoreLIMS program to deploy Clinisys WinPath to all five health and social care trusts and the blood transfusion service in Northern Ireland.

-SERI and Carl Zeiss Meditec collaborate to improve vision care in Singapore

--The Singapore Eye Research Institute (SERI) and Carl Zeiss Meditec AG, one of the world's leading medical technology companies, have entered into a strategic partnership to advance surgical outcomes in refractive and cataract surgeries.

-Boston Scientific closes acquisition of Axonics, Inc

--Boston Scientific Corporation has announced the close of its acquisition of Axonics, Inc., a medical technology company focused on the development and commercialisation of differentiated devices to treat urinary and bowel dysfunction.

-Pulses of light show promise in controlling seizures

--In what could one day become a new treatment for epilepsy, researchers at UC San Francisco, UC Santa Cruz and UC Berkeley have used pulses of light to prevent seizure-like activity in neurons.

-Chimeric tagging technique offers new hope in the fight against drug-resistant infections

--A new study has developed an innovative approach to combat antibiotic-resistant bacteria by tagging them with a chimeric agent that activates the immune system towards them.

-Evo model set to transform synthetic biology and disease diagnosis

--A new study presents "Evo" – a machine learning model capable of decoding and designing DNA, RNA, and protein sequences, from molecular to genome scale, with unparalleled accuracy. Evo's ability to predict, generate, and engineer entire genomic sequences could change the way synthetic biology is done.

-Computer-assisted CBT and mental health apps effective in reducing anxiety, depression symptoms

--Computer-assisted cognitive-behavior therapy (CCBT) and mobile mental health applications warrant continued development and ongoing efforts to increase acceptance among patients and clinicians, according to a review published in the Journal of Psychiatric Practice, part of the Lippincott portfolio from Wolters Kluwer.

-EASI algorithm set to transform forensic drug identification processes

--Relief is coming for crime scene investigators and toxicologists who have struggled to accurately and swiftly identify drugs that have been seized by law enforcement and may be relied on as evidence at trial, thanks to a research partnership between West Virginia University and the U.S. Drug Enforcement Administration.

-Blood-derived materials show promise in bone regeneration

--Scientists have created a new 'biocooperative' material based on blood, which has shown to successfully repair bones, paving the way for personalised regenerative blood products that could be used as effective therapies to treat injury and disease.

-MEMPHIS system sheds light on vaccine response differences across ages

--mRNA vaccines saved lives during the COVID-19 pandemic, but older people had less of an immune response to the vaccines than did younger adults. Why? Boston Children's researchers, led by Byron Brook, PhD, and Ofer Levy, MD, PhD, have found some answers, while providing proof-of-concept of a new system that can model vaccine responses in a dish.

-Engineered virus-like particles evolve for superior gene delivery efficiency

--Researchers developed a barcoded directed evolution system for engineered virus-like particles (eVLPs), creating a fifth-generation (v5) eVLP with enhanced production, transduction, and gene-editing efficiency. This system could pave the way for improved gene delivery vehicles in therapeutic applications.

-CARMAT's Aeson device gains momentum in Europe as a bridge-to-transplant solution

--CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “CARMAT”), provides an update on Aeson® artificial heart’s uptake as a bridge to transplant in Europe.

-AI algorithm accurately detects early-stage metabolic-associated steatotic liver disease

--Liver disease, which is treatable when discovered early, often goes undetected until late stages, but a new study revealed that an algorithm fueled by artificial intelligence can accurately detect early-stage metabolic-associated steatotic liver disease (MASLD) by using electronic health records.

-Paragon 28 to Present at the 36th Annual Piper Sandler Healthcare Conference ENGLEWOOD, Colo.--(BUSINESS WIRE)

--Paragon 28, Inc. (NYSE: FNA), a leading medical device company exclusively focused on the foot and ankle orthopedic market, announced that Albert DaCosta, Chairman and CEO, and Chadi Chahine, CFO, will participate in a fireside chat at the 36th Annual Piper Sandler Healthcare Conference on Tuesday, December 3, 2024, at 8:30 a.m. Eastern Time / 6:30 a.m. Mountain Time.