Pulse Biosciences Inc. received U.S. FDA breakthrough device designation for its Cellfx cardiac surgery system with surgical clamp for ablation of atrial fibrillation. The Cellfx system uses nanosecond pulsed field ablation technology to deliver durable, continuous transmural ablation. Read More
Endoron Medical Ltd. raised $10 million in its series A funding round to accelerate clinical validation work on its catheter-based endostapling system, Aortoseal, which repairs abdominal aortic aneurysms. The round was led by Sofinnova Partners, with participation from the European Innovation Council Fund. Read More
The U.S. Medicare draft prospective payment system for end-stage renal disease encodes a few changes that will cheer industry, including a provision that would increase patient access to pharmaceuticals that are available only in oral form. Read More
Soligenix Inc. investors were extremely enthusiastic about the positive interim update for the company’s cancer therapy and light device, Hybryte, for treating for treating early stage cutaneous T-cell lymphoma. The Princeton, N.J.-based company’s stock (NASDAQ:SNGX) soared a whopping 464% before closing at a more modest but still massive of 271% increase to $7.42 each on July 9. Read More
The U.S. FDA warning letter to AG Essence Inc., a maker of wound care products, raised the question of whether the the company’s Banda product line is a drug or a device, although the FDA’s device center was the issuer of the warning letter. However, the company told ioWorld that it sees its offerings as homeopathic products rather than as drugs or devices, suggesting that this product jurisdiction scrum is far from over. Read More
In the first six months of 2024, the med-tech industry raised $13.84 billion, a 29% increase from the $10.75 billion collected during the first half of 2023. While May saw a significant $5.05 billion raised, the monthly total decreased to $1.14 billion in June. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
New hires and promotions in the med-tech industry, including: Access Vascular, Boston Bioproducts, Genesis Innovation, Illuminoss, Lunit, Newcells, One2treat. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axena, Cresilon, Icecure, Microvention, Sera Prognostics, Sinaptica. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aktiia, Allucent, Biosecure ID, Lindus Health, Neurobrave, Neurox, Paragon Genomics, Recovery Force, Skylinedx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cordis, Curonix, Forma, Mainstay, Orthofix, Roche, Tactile Systems Technology. Read More
