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Home » Topics » Regulatory

Regulatory
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olympus-meditate-itind.png

FDA gives de novo nod to Itind for benign prostatic hyperplasia

April 6, 2020
By Meg Bryant
Olympus Medical Systems Group, of Center Valley, Pa., a division of Olympus Corp., is preparing the U.S. launch of the Itind device for the treatment of benign prostatic hyperplasia (BPH), following FDA de novo authorization earlier this year. The nonsurgical, minimally invasive treatment is made by Medi-Tate Ltd., of Or-Akiva, Israel.
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Axonics-r-snm-11-18.jpg

Axonics looks to expand reach with its r-SNM system

April 6, 2020
By Liz Hollis
Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.
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Regulatory front for April 6, 2020

April 6, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Mimedx.
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Regulatory actions for April 6, 2020

April 6, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medi-Tate, Merit Medical, Olympus.
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Regulatory actions for April 6, 2020

April 6, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, BMS, Daiichi, Eisai, GW, Histogen, Hope, Mallinckrodt, Mateon, Mesoblast, Novo Nordisk, Takeda, Tetra, Tracon.
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Regulatory front for April 6, 2020

April 6, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Gilead.
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FDA approves Reblozyl to treat anemia in MDS

April 6, 2020
Canadian flag

Ottawa recruits Canadian equipment makers in CA$2B COVID-19 battle

April 3, 2020
By David Godkin
TORONTO – Canadian Prime Minister Justin Trudeau has yet to rule out following U.S. President Donald Trump’s lead by invoking his nation's wartime Defense Procurement Act compelling manufacturers to begin making ventilators to combat COVID-19. For now, Ottawa has signed contracts or letters of intent with eight equipment makers.
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Telehealth illustration

FCC doubles down on existing telehealth pilot, draws raves from advocates

April 3, 2020
By Mark McCarty
The U.S. Federal Communications Commission (FCC) has received funds for another telehealth program in less than a year. An agency statement indicates that the program “would immediately support health care providers” working to thwart the COVID-19 outbreak. This would be achieved in part by supporting purchases of devices and other items needed to provide telehealth, which the Connected Health Initiative said will help drive an overdue overhaul of health care in the U.S.
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Regulatory front for April 3, 2020

April 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
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