With an oversubscribed $30 million series B in hand, Carlsmed Inc. is in a good posture to take the next steps in its plan to make its personalized spinal implants central to ending frequent revisions in spine surgery. The company’s Aprevo devices, which are 3D printed for each patient, received FDA breakthrough device designation and 510(k) clearance in late 2020. Read More
Carmat SA just completed a funding exercise, raising nearly $44 million to resume production and implantation of its Aeson total artificial heart, designed for patients suffering from end-stage bi-ventricular heart failure. The capital raise was achieved by issuing 4.05 million new shares on the Paris Euronext exchange, at a fixed price of $10.81 a share. Read More
The Medicare new technology add-on (NTAP) program is a vital source of reimbursement rates for novel technologies, and several NTAP applications were extended by a year in 2021 because of the COVID-19 pandemic. That extension is set to expire for several key products, including the Eluvia drug eluting stent by Boston Scientific Corp., of Marlborough, Mass., and the Spinejack system by Stryker Corp., of Kalamazoo, Mich., forcing these companies to amortize their R&D costs at a more conventional pace. Read More
The amount of money raised by med-tech companies in the early months of 2022 is the lowest amount recorded for a first quarter since 2017. Financings in 2021 were down by 17% over the prior year, which was marked by a flurry of activity and interest in digital technologies and diagnostics with the onset of the COVID-19 pandemic. Read More
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld. Read More
The FDA’s device center issued a safety communication advising that non-invasive genetic prenatal screening tests that are used to establish whether a fetus has a genetic abnormality can yield incorrect results. The problem stems in part from the fact that the agency has not yet reviewed any such tests, which are often administered as lab-developed tests (LDTs). Read More
New hires and promotions in the med-tech industry, including: Avellino Lab USA, Biomedical Bonding, Butterfly Network, Cloudcath, Saluda Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Achiko, Boehringer, Domus, Innit, Labcorp, Mivi, Roche, Stimwave, Vantai, Xcell Biosciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: The Orthopaedic Implant Company, Zeiss. Read More
