MDIC Curates: Weekly Industry News Round-Up

Curated industry news detailing the latest within regulatory science and medical device innovation.

FDA takes N95 respirators off medical device shortage list

Supply Chain Dive | August 30, 2022

The Food and Drug Administration has taken N95 respirators off of the medical device shortage list as increased manufacturing has helped build a sufficient supply of the devices. In a Friday statement, the agency wrote that the “demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply.”

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Inari Medical Announces Three New Data Sets to be Presented During Late-Breaking Clinical Trial Sessions at the 2022 TCT and VEINS Conferences

Biospace | September 1, 2022

IRVINE, Calif., Sept. 01, 2022 (GLOBE NEWSWIRE) –Inari Medical Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced three new data sets will be presented during Late-Breaking Clinical Trial sessions at the 2022 TCT (Transcatheter Cardiovascular Therapeutics) and the 2022 VEINS (Venous Endovascular Interventional Strategies) conferences…

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Can AI Deliver a More Accurate Cancer Prognosis?

MedScape | September 1, 2022

It’s hard figuring out what the road ahead will look like for a cancer patient. A lot of evidence is considered, like the patient’s health and family history, grade and stage of the tumor, and traits of the cancer cells. But ultimately, the outlook comes down to health professionals who analyze the facts…

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eCential Robotics receives FDA clearance for its surgical robotic platform for spine surgery

Biospace | September 1, 2022

GIÈRES, France, Sept. 1, 2022 /PRNewswire/ — eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, today announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States

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U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants

Biospace | August 31, 2022

The US Food and Drug Administration (FDA) has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced today…

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BrainsWay Receives New FDA Clearance for Treating Depression and Anxious DepressionDepression Clearance for the Proprietary Deep TMS™ H7 Coil Represents the Company’s 9th FDA Clearance

BURLINGTON, Mass. and JERUSALEM, Aug. 29, 2022 (GLOBE NEWSWIRE) –Brainsway Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Deep TMS™ H7 Coil for its use in treating adults suffering from major depressive disorder and depression including those with comorbid anxiety symptoms commonly known as anxious depression…

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