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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 6, 2020

View Archived Issues
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Zimmer Biomet beats consensus in Q3, withholds 2020 guidance

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
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HHS general counsel: FDA’s argument regarding LDT regulation falls short on several points

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
Lab equipment for cell-free DNA testing

Common mutations produce false positives in liquid biopsies used to guide cancer treatment

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

NICE reviews how it evaluates drugs, devices and diagnostics

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
Illustration of ear anatomy, traditional cochlear implant

Med-El sees first procedure with fully implantable hearing system

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

FDA authorizes serology test for neutralizing antibodies

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

Appointments and advancements for Nov. 6, 2020

New hires and promotions in the med-tech industry, including: Marizyme, Nephros. Read More

Financings for Nov. 6, 2020

Med-tech firms raising money in public or private financings, including: Novocure. Read More

In the clinic for Nov. 6, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Caredx, Limflow, Zimmer Biomet. Read More

Med-tech gainers and losers for Nov. 2-6, 2020

The top 10 med-tech stock gainers and losers for the week. Read More

Other news to note for Nov. 6, 2020

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 actions for Nov. 6, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Genscript. Read More

BioWorld MedTech’s Neurology Extra for Nov. 6, 2020

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

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