Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
Glucomodicum Oy reported positive results from a clinical study in which its needle-free continuous glucose monitor, Talisman, was tested in participants across both standard multi-hour glucose tolerance and ambulatory conditions involving exercise and meals.
The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
Robert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.
Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
Focused on promoting well-being amongst children with neurodivergence, Reset Moves Pty Ltd. created app-based games to help children not only focus with greater clarity, but also to better help them re-engage in certain settings.
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock...
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could...
The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating...
Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based
diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
Classically, the diagnosis of type 1 diabetes comes after a patient presents with unexplained weight loss, extreme thirst and frequent urination and a lab test reveals off-the-charts blood glucose levels. At the 85th Scientific Sessions of the American Diabetes Association in Chicago, researchers...
In a bid to boost its multiomics holdings, Illumina Inc. reported an agreement to buy proteomics technology company Somalogic Inc. from Standard Biotools Inc. for $350 million in cash, plus up to $75 million in near-term performance-based milestones and performance-based royalties.
Despite raising the price of its IPO twice, Caris Life Sciences Inc. left money on the table with a 33% increase in price as soon as trading commenced on the Nasdaq, though no one is squawking about raising nearly $500 million. The cancer diagnostics company initially priced its IPO at $16 to $18,...
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.
Abbott Laboratories grabbed attention in early June with its announcement of a partnership with Tandem Diabetes Care Inc. to develop a multianalyte sensor for people with diabetes that would measure ketones as well as glucose.
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
With a growing number of people wearing continuous glucose monitors and an ever-shrinking number of hospital-based nurses, bringing your own device or using personal CGMs to measure glucose levels during hospitalizations seems like a no-brainer.
The U.K. government will offer women home-testing kits for cervical screening as part of an effort to tackle barriers and get more of them taking this potentially life-saving test.
Pregnant women with type 1 diabetes who used a hybrid closed loop automated insulin delivery system averaged more than three additional hours per day in their recommended glucose range than those who managed their diabetes with insulin injections...
At the American Diabetes Association 85th Scientific Sessions in Chicago June 20-23, Fractyl Health Inc. presented results from two studies evaluating very different approaches to treating – and possibly curing – type 2 diabetes.
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to...
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical...
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.