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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 30, 2021

View Archived Issues
Person using COVID-19 antigen test at home

FDA says antigen tests are less sensitive to Omicron

The run on at-home COVID-19 tests may be for naught. The FDA warned that the popular rapid antigen tests recommended to keep New Year’s Eve revelers, relatives visiting elderly grandparents and workers exposed to the coronavirus from spreading COVID-19 are less likely to detect the Omicron variant than earlier strains of the virus. “Early data suggest that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said in an update on Dec. 29. Despite the higher rate of false negatives, the FDA said individuals should continue to use the tests. Those experiencing symptoms or with a high likelihood of infection based on exposure should follow-up with a molecular test if their antigen test returns a negative result. Read More
regulatory-washington-us-flag.png

VALID Act enjoys good odds of passage, but regulatory enactment no mean feat

The Verifying Accurate Leading-edge IVCT Development (VALID) Act seems poised for passage in 2022, a bit of welcome relief for those stuck in the regulatory twilight world of the lab-developed test (LDT). However, Carly McWilliams, director of regulatory policy for North America for Roche Inc., said recently at the recent Food and Drug Law Institute enforcement meeting that the VALID Act is likely to leave the question of a user fee schedule for a future Congress, given that the associated rulemaking, guidance development and compliance activities are likely to consume the better part of, if not the entirety of, the next five years. Read More
Rocket launch illustration

The Israeli incubator nurturing the next generation of med-tech innovation

The need to develop advanced medical technologies is ever increasing, and one incubator is on a mission to identify the world’s most promising opportunities. In cooperation with partners including Israel Innovation Authority, Israeli incubator Medx Xelerator LP is expanding a portfolio of startups that are attacking some of health care’s biggest challenges. Read More
Australia-flag-health-tech.png

Australia is falling behind in accessing innovative drugs, devices

PERTH, Australia – Australia should be at the front of the line among developed nations when it comes to innovative drugs and devices, but health policies must evolve to respond to changes in technology and global trends, Johnson & Johnson (J&J) said. Although Australia’s health policy has served the country well, tensions in the system are becoming seismic shifts that mirror international trends, J&J said in a recent report on Australia’s health system. Read More
Person transitioning from wheelchair to walking

Onward nears commercialization of its electrical spinal cord stimulation system

PARIS – Two months after successfully listing on Euronext Brussels and Euronext Amsterdam stock exchanges, raising nearly $100 million, Onward Medical NV reported completion of enrollment in its Up-LIFT study on its noninvasive electrical spinal cord stimulation, called Arc therapy. Read More

Appointments and advancements for Dec. 30, 2021

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

Other news to note for Dec. 30, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Essity, Hydrofera, Milliporesigma, Pythagoras Medical, Symap Medical. Read More

Regulatory actions for Dec. 30, 2021

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

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