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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

June 16, 2021

View Archived Issues
dollar-idea-lightbulb.png

Fractyl nabs $100M to advance device for reducing insulin dependence

Fractyl Health Inc. closed $100 million in new financing Wednesday to expand and accelerate clinical development efforts to reduce dependence on insulin among type 2 diabetes patients. The startup, which changed its name from Fractyl Laboratories Inc., will use the financing to support additional late-stage clinical studies for determining the potential of its Revita DMR. Read More
Escherichia-Coli-bacteria.png

Phenofast clears up one mystery for UTIs and gains support from an incubator

Mindup, an Israeli digital health incubator, added Phenofast Ltd. to its portfolio this week, banking on the startup’s ability to resolve a critical, ongoing problem for hospitals and community physicians treating patients with urinary tract infections (UTIs). Phenofast hopes to bring clarity to antimicrobial susceptibility testing (AST) and relief to patients in record time. Read More
Aura6000 device, illustration showing placement

Livanova gets FDA nod for pivotal sleep apnea trial

Livanova plc has launched an IDE trial of its Aura6000 sleep apnea device, following approval by the FDA to proceed with the study. The implantable pulse generator (IPG) is designed to treat patients with moderate to severe obstructive sleep apnea (OSA) who do not get relief from a traditional continuous positive airway pressure (CPAP) machine or refuse to use one. Read More
Central nervous system

FDA deems brain-computer interface guidance a leapfrog document

With paralysis affecting more than 5 million Americans, devices that serve as brain-computer interfaces (BCIs) are increasingly important, even if few are commercially available. The FDA has responded to the predicament with a leapfrog guidance, a preliminary form of guidance designed to foster more interaction with industry and encourage developers to move along on development programs for devices that will aid patients in restoring lost motor and/or sensory capabilities. Read More
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PMDA moves to speed up approvals of innovative devices, improve predictability

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has been stepping up efforts to bring innovative medical devices to market faster and make the regulatory approval process more predictable and further speed up approval processes that have been known for long delays. Read More
Stratagraft

Mallinckrodt wins FDA nod for regenerative skin therapy for burns

More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. Read More

In the clinic for June 16, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Natera, Novocure, Motus GI, Relievant Medsystems. Read More

Other news to note for June 16, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alydia Health, Behold.ai, Electrocore, Intermountain Healthcare, Medx Health, Myriad Genetics, Organon & Co., Pieriandx, Si-Bone, Vidaceuticals Health Products. Read More

Regulatory actions for June 16, 2021

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

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