The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation. Read More
There is no doubt that the fundraising environment in Europe remains challenging for med-tech companies. Currently it seems like “the winner takes it all,” with companies that have de-risked their portfolio able to find investors to provide funds, while for those at the earlier stages, finding capital continues to be ‘tricky,’ Raphaël Wisniewski, partner at European private equity firm Andera Partners, told BioWorld in an interview. Read More
Researchers at Mount Sinai have identified a unique neuron type that could explain vulnerability in Parkinson’s disease and thus help unravel the neuronal complexity of this disorder – hopefully leading to more precise and effective therapies. The findings, published in Science Advances on Jan. 10, 2024, provide new insights into the genetic causes and changes occurring in substantia nigra during PD pathogenesis. Read More
Spyglass Ophthalmics Inc. is seeking patent protection for intraocular drug delivery devices and methods of delivering therapeutic agents to the eye. The methods include implanting an intraocular implant into the eye and adjacent to a fluid-permeable membrane of the patient’s eye. Read More
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Astrazeneca, Delve Health, Life Molecular Imaging, Navignostics, Neurosense, Oryx Isotopes Industrial, Perimed, Principal Technologies, Quantum-Si, Serendipity Partners, Shiratronics, Sophia Genetics, Standard Biotools, Vivostat. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Tyber Medical. Read More
