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Home » FDA

Articles Tagged with ''FDA''

Green traffic light

Neuronetics wins FDA nod for Neurostar TMS for OCD

May 11, 2022
By Meg Bryant
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
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2022 MedCon

Cybersecurity expertise still in short supply, but solution nowhere in sight

May 9, 2022
By Mark McCarty
Cybersecurity remains a pressing issue for medical technology, in part because there are new, small companies jumping into this space seemingly every day. However, there is a shortage of talent in cybersecurity, something that Dan Lyon, director of cybersecurity at Boston Scientific Corp., of Marlborough, Mass., said will not ease soon due to a lack of interest among colleges and universities in providing curriculum and degrees in this area.
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FDA announces investigation into Fresenius hemodialysis units

May 9, 2022
By Mark McCarty
The U.S. FDA reported it is evaluating the potential for exposure to some chemicals associated with the use of several models of hemodialysis machines made by Fresenius Medical Care Inc., of Waltham, Mass., including units that are no longer in production.
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Lumipulse-G

FDA grants Fujirebio first marketing authorization for in vitro diagnostic for Alzheimer’s

May 5, 2022
By Annette Boyle
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
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U.S. Capitol building, Washington D.C.

House user fee bill omits action on lab-developed tests, SaMD

May 5, 2022
By Mark McCarty
The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency.
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FDA grants Fujirebio first marketing authorization for in vitro diagnostic for Alzheimer’s

May 5, 2022
By Annette Boyle
Mark it as a day to remember. Today the FDA authorized the first in vitro diagnostic test for Alzheimer’s disease, enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
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Mirvie wins breakthrough device designation for pre-eclampsia risk test

May 4, 2022
By Catherine Longworth
Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
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Orthofix AccelStim

Orthofix gets a break with FDA approval of new bone healing device

May 4, 2022
By Annette Boyle
Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks.
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U.S. FDA headquarters
2022 MedCon

FDA’s Shuren: Quality management harmonization final rule won’t arrive in 2022

May 4, 2022
By Mark McCarty
The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is flexible on the proposed one-year implementation deadline. However, Shuren also noted that the draft rule would not be converted into a final rule at any point during the current calendar year, leaving device makers with an extended term of uncertainty.
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Mesh litigation continues apace despite years of FDA scrutiny over safety

April 21, 2022
By Mark McCarty
The U.S. FDA has been scrutinizing surgical meshes for safety considerations for longer than a decade, but litigation continues to dot the legal landscape. An appeals court in the state of California decreed recently that Johnson & Johnson of Franklin Lakes, N.J. must pay more than $300 million over allegations that its Ethicon subsidiary had downplayed to patients the risks associated with its pelvic meshes, but J&J said its next step is to appeal the outcome in the state’s highest court.
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