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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Feb. 1, 2022

View Archived Issues
Kidneys

Applaud Medical wins FDA breakthrough device designation for urinary stone device

Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy. Read More
Packaging and kit components

Testing shortage persists in US despite billions spent by federal government

The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term. Read More
Glooko platform on desktop, smartphone

Glooko acquires Xbird to expand digital health support for diabetes

Glooko Inc. acquired Xbird GmbH to further build out its diabetes management platform by adding Xbird’s just-in-time artificial intelligence (JITAI) system to provide adaptive interventions that can enable better informed decision making in the moment. The company declined to provide details of the transaction. Read More

Will US FDA commissioner seat be filled any time soon?

More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air. Read More
Intra-op image of incision with the inserted Inspan ISP device

FDA-cleared spinal stenosis device aimed squarely at interventional pain physicians

Inspan LLC has won FDA 510(k) clearance for an interspinous fixation system that can now be used to treat lumbar spinal stenosis in non-cervical spine cases of spondylolisthesis, trauma, tumor and degenerative disc disease. According to Aditya Humad, co-founder and CFO of Kicventures Group which counts Inspan among its portfolio companies, FDA clearance represents an expansion in the use of Inspan’s interspinous system into the “highly competitive space” of interventional pain management. Read More

NICE offers selective laser therapy for glaucoma and ocular hypertension

The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of selective laser therapy treatment (SLT) instead of eyedrops as treatment of chronic open-angle glaucoma (COAG) and ocular hypertension. The shift would seem to drive spending in the U.K. away from drugs and toward devices for a condition afflicting nearly 10% of citizens over the age of 75. Read More

Appointments and advancements for Feb. 1, 2022

New hires and promotions in the med-tech industry, including: Implantica, Nanoscope Therapeutics, Resmed, Sema4, Sensus Healthcare. Read More

Financings for Feb. 1, 2022

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

In the clinic for Feb. 1, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytosorbents, Eko, Electrocore. Read More

Other news to note for Feb. 1, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Ambra Health, BD, Butterfly Network, Cognetivity, Conquer Scientific, Convatec, Cytognos, Genedit, Gentech, Ignite Data, Purity Scientific, Sarepta, Sera Prognostics, Triad Life Sciences, Twist Bioscience, ZS. Read More

Regulatory actions for Feb. 1, 2022

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

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