Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.
Proteomics International Pty Ltd has developed a new blood-based diagnostic test called the Promarkereso that identifies patients with esophageal adenocarcinoma as well as patients with a pre-malignant condition called Barrett’s esophagus that can arise from chronic acid reflux.
Artificial intelligence (AI) is an increasingly common matter of medical practice and thus not just another buzzword, and the U.K. National Institute for Health and Care Excellence (NICE) has opened a program for evidence generation for the use of AI to contour external beam radiotherapy to the tumor of treatment.
The co-founder and CEO of Total Flow Medical Ltd, Hilary Pierce, reported the filing of a patent for bidirectional flow cannulas configured and designed to replace conventional femoral arterial cannulas for extracorporeal circulation during cardiopulmonary bypass procedures and that provide an optional dedicated blood flow to the ipsilateral limb.
Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future.
Proteome analysis with artificial intelligence has made it possible to create a catalog of all possible missense mutations in the human genome to predict diseases.
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of...
The French National Insurance Fund, known as La Caisse Nationale d’Assurance Maladie, a division reporting to the Ministry of Health and the Ministry of Economics and Finance in France, has released its annual report containing proposals aimed at achieving financial balance in the nation’s health...
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the...
CMR Surgical Ltd. raised $165 million in financing from its existing investors that will allow the company to continue to innovate its portable robotic surgery system, Versius, and grow its position in existing and new markets. The latest financing takes CMR’s total capital raised since its...
Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive...
The identification of new targets in diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s – conditions which continue to have significant unmet needs – has taken a small step forward as one company, Violet Therapeutics Inc., plans to put $10.6 million in seed funding...
University of Chicago spinoff Flow Medical Inc. is finalizing its design of a multi-function catheter to diagnose and treat venous thromboembolic disease – boosted by a $1 million private investment to commercialize the device.
SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in...
The U.S. Federal Trade Commission has picked Henry Liu of the law firm of Covington & Burling to run the agency’s Bureau of Competition, a seat that was vacated earlier this year when Holly Vedova retired.
Tandem Diabetes Care Inc. obtained reimbursement in France for its Control-IQ technology, an advanced hybrid closed loop system for patients with type 1 diabetes that uses an algorithm to automatically adjust insulin in response to predicted glucose levels.
Med-tech deal values the first seven months of the year are up more than 50% from last year. Meanwhile, M&As decreased almost 70% from the same time period in 2022.
With a waiting list of some 90,000 people, startup company Charco Neurotech Ltd. is seeing growing demand for its Cue1 device which has shown to reduce the symptoms of Parkinson’s disease in patients suffering from the condition. The Cue1 is a non-invasive device that can literally change the...
An artificial intelligence (AI) tool developed by Annalise.ai Pty Ltd. was able to improve radiologists’ accuracy in detecting abnormalities on non-contrast computed tomography brain (CTB) scans. According to a study published in European Radiology, the Annalise Enterprise CTB module improved...
Researchers at Singapore’s Agency for Science Technology & Research Bioprocessing Technology Institute (also known as A*STAR BTI) saw publication of their patent application for a wearable electronic system for solid-state epidermal biomarkers (SEB) that enables in situ, continuous, multiplexed,...
A fluorescent imaging agent developed by Vergent Bioscience Inc. enables visualization of elusive and previously undetected tumors, a phase II study presented last week at the 2023 World Conference on Lung Cancer (WCL23) demonstrated. The ability of the tumor-targeting agent, Vgt-309, to illuminate...
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The...
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...
A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities...
For many sports injuries, return-to-play decisions are pretty straightforward: pain and swelling have dissipated, or an X-ray confirms that a bone has healed. For concussion, it’s not so clear. Though symptoms may resolve after a few days, the...
Personadx Inc. and researchers from the University of Chicago Medicine Comprehensive Cancer Center have developed a method to accurately predict which patients with metastatic colorectal cancer will have a favorable treatment outcome following...
In game-changing news for parents of children with cerebral palsy, researchers demonstrated significant clinical improvement in the sensorimotor function of children who underwent sessions using Spinex Inc.’s Spinal Cord Innovation in Pediatrics...
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.