BioWorld - Monday, June 17, 2024
Breaking News: Merck’s pneumococcal vaccine, Capvaxive, wins U.S. FDA approvalBreaking News: Try BioWorld for free for two weeksBreaking News: Try BioWorld for free for two weeks-
Siemens Healthineers AG has received CE mark for a neurofilament light chain assay to help with the early diagnosis of multiple sclerosis and aid in predicting the risk of relapse in patients suffering from the disease. The test developed in collaboration with Novartis Pharma AG will be launched in Europe later this year.
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Siemens Healthineers AG has received CE mark for a neurofilament light chain assay to help with the early diagnosis of multiple sclerosis and aid in predicting the risk of relapse in patients suffering from the disease. The test developed in collaboration with Novartis Pharma AG will be launched in Europe later this year.
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For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.
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The top 10 med-tech stock gainers and losers for the week.
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BioWorld MedTech briefs for June 17, 2024.
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With all the criticism the U.S. NIH has been getting of late, it’s not surprising that yet another reform proposal for the research agency is brewing in Congress. In unveiling a proposed framework to reform the NIH, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) recognized the critical role the agency plays in life-saving medical research and innovation.
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Elutia Inc. received U.S. FDA clearance for its antibiotic-eluting bioenvelope. Designed to prevent post-operative complications from the implantation of cardiac devices such as pacemakers and defibrillators, Elupro (formerly Cangaroo RM) combines slow release of the antibiotics rifampin and minocycline with a biomatrix that stimulates regeneration of a tissue pocket to surround and protect the device.
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Criticisms over the U.S. FDA’s use of advisory committees led the agency to hold a June 13 public hearing during which FDA commissioner Bob Califf said the agency is working to improve the experience of special government employees who take part in these hearings.
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Regulatory
Aktiia SA recently received a CE mark for Calfree, its optical blood pressure monitoring technology that does not require calibration with a traditional cuff. The Calfree system can be integrated into a wide range of third-party devices, significantly improving hypertension management and as a...
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Regulatory
The U.S. National Institutes of Health has jumped into the artificial intelligence pool with a prognostic that predicts a patient’s response to immune checkpoint inhibitors as cancer therapies.
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Financings
South Korean digital health care firm Seers Technology Co. Ltd. is targeting a ₩22.1 billion (US$16.2 million) IPO on the Korea Exchange, after upping the offering price of its 1.3 million shares to ₩17,000 per share on June 4.
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Respiratory
London, Ontario-based Deep Breathe Inc. filed for protection of a wearable ultrasound sensor that is used to obtain ultrasound data, and digital ultrasound images are processed using a machine learning model to predict the probability of lung sliding and detection of pneumothorax (collapsed lung)...
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IPO
A week after generating buzz with its proposed Nasdaq listing and plans to raise about $200 million, Telix Pharmaceuticals Ltd. withdrew its U.S. IPO filing, citing market conditions. The Australian radiopharma firm’s shares continue trading on the Australian Securities Exchange (TLX), where they...
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Artificial intelligence
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Gastrointestinal
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Urology
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Analysis and data insight
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Cancer
The first patenting from San Francisco-based Ananya Health Inc. describes its development of a closed-loop cryoablation platform to freeze abnormal cells before they become cervical cancer. The company’s device achieves ablative temperatures without consumable gas, making the procedure portable,...
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Diabetes
Focused on oral therapies for obesity, diabetes and rare diseases, Boston-based Syntis Bio Inc., which raised $15.5 million through seed funding last year, emerged from stealth to advance its synthetic tissue-lining technology and a pipeline of candidates.
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Regulatory
Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.
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Cancer
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Regulatory
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Aging
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Financings
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Analysis and data insight
In 2023, med-tech deals culminated in the highest total deal value ever recorded by BioWorld MedTech, totaling $10.63 billion, a 33% increase from the $7.99 billion recorded in 2022.
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Cardiovascular
Edwards Lifesciences Corp. is selling its critical care product group to Becton Dickison and Co. (BD) for $4.2 billion in cash, forgoing its previously announced plans to spin off the unit into a separate business. The transaction is expected to close before the end of the calendar year.
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Cardiovascular
Surmodics Inc. reported plans to be acquired by private equity firm Golder, Thoma, Cressey, Rauner Inc. for $43 a share for a total equity valuation of approximately $627 million. The per-share acquisition price represents a 41.1% premium to Surmodics’ 30-trading day volume-weighted average closing...
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Cardiovascular
Nordson Corp. said it will buy Atrion Corp. for $460 per share in cash, representing a total equity value of approximately $815 million. The transaction enterprise value reflects a multiple of 20.2 times Atrion's 2023 EBITDA, and the $460 per share price represents a 15% premium to Atrion's 90-day...
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Regulatory
Despite the ongoing war, speakers at Biomed Israel this week reported that business and investment in Israel’s med-tech industry continues largely unchanged.
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Drug design, drug delivery and technologies
In what represents its first patenting Demon Curonix BV is seeking protection for a system for providing microvesicles to be used in combination with focused ultrasound for drug delivery to the brain.
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Financings
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Dialysis
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Financings
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Regulatory
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Regulatory
As renal denervation (RDN) makes a comeback for treatment-resistant hypertension, Deepqure Inc. is advancing its RDN medical device dubbed Hyperqure with the U.S. FDA granting clearance for a U.S.-based study.
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Regulatory
Molecular diagnostics company Genetic Signatures Ltd. is gearing up to launch its Easyscreen gastrointestinal parasite detection kit in the U.S. following its first FDA 510(k) clearance.
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Artificial intelligence
Dornier Medtech launched a first-of-its-kind artificial intelligence tool called Urogpt to support patients with kidney stones. Developed in collaboration with leading urologists, Urogpt marks a milestone in the company's commitment to leveraging digital innovation to empower kidney stone sufferers...
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Regulatory
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Clinical
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Regulatory
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Conferences
Astrazeneca plc’s blockbuster Enhertu continued to garner attention as new data released at the American Society of Clinical Oncology (ASCO) annual meeting show the antibody-drug conjugate demonstrated strong progression-free survival in...
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Gastrointestinal
Researchers affiliated with the U.K.’s University Hospitals Birmingham NHS Foundation Trust filed for protection of a device for treating simple or complex anal or rectovagin*l fistulas which is less invasive and more effective than existing...
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Cardiovascular
Volta Medical SAS reported positive results from the Tailored-AF study which compared its artificial intelligence software-guided ablation procedure in combination with pulmonary vein isolation to a conventional anatomical ablation targeting PVI...
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EuroPCR
Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional...
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EuroPCR
Elixir Medical Corp. reported positive 12-month clinical data from the Desyne BDS Plus randomized controlled trial which evaluated its Desyne BDS plus system, a triple drug-eluting coronary implant with site-specific antithrombotic therapeutic...
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Cancer
Liquid biopsy typically means blood testing, but several companies presenting at Biomed Israel May 21-23 have developed diagnostics that look to other, even less invasive options, and ever broader applications. Nevia Bio Ltd. is using vagin*l...
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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.The news source of record covering the development of innovative human therapies for 25+ years
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