Zimmer Biomet Holdings Inc. fell in line with other orthopedic device companies that saw better than expected results for the 2020 third quarter. The company reported total revenue of $1.93 billion, up 1.1% from the same period in 2019. Read More
The controversy over the U.S. FDA’s authority to regulate lab-developed tests (LDTs) took on a new set of considerations due to the COVID-19 pandemic. However, a June 22 memo by HHS General Counsel Robert Charrow pokes holes in the FDA’s argument on several fronts. Among these is the question of whether an LDT can be regulated by the FDA, given that a test is not usually offered for sale across state lines. Read More
The use of liquid biopsies, tests that look for variants in cell-free DNA (cfDNA) shed by tumors into blood plasma, could lead to misdiagnosis and inappropriate treatment in many cancers, according to University of Washington researchers. The tests misidentified a noncancer mutation that is particularly common in older people as a mutation used as a biomarker for PARP inhibitors indicated for use in prostate cancer, a study published in JAMA Oncology found, but the problem likely extends to other malignancies. Read More
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation. Read More
PARIS – Med-El Elektromedizinische Geräte GmbH has reported the first successful procedure in Europe for a totally implantable cochlear implant (TICI). The surgery was performed at Liège University Hospital in Belgium. “This TICI is a major step in cochlear implant technology. It has been the aim since the beginning of cochlear implants to be able to integrate all the components into a single internal device,” Philippe Lefebvre, head of the otorhinolaryngology department at Liège University Hospital, told BioWorld. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA tweaks export final guidance per CARES Act; OIG: CMS should act to recover payments for device credits. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioelectronics, Careprotocol, Decision Diagnostics, Djo, Genassist, Hancock Jaffe, Mesa Biotech, Orthoalign, Progenity, Scott Specialties, Verida. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Genscript. Read More
Keeping you up to date on recent developments in neurology, including: AI helps detect brain aneurysms on CT angiography; BBB studies advancing focused ultrasound treatment for Parkinson’s; Study reveals unexpected protective role for brain swelling after injury. Read More
