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BioWorld - Sunday, July 3, 2022
Home » Topics » Regulatory

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FDA gives green light to Minnetronix Medical’s neurosurgical access platform

Sep. 9, 2020
By Meg Bryant
No Comments
Minnetronix Medical Inc. has won the U.S. FDA’s nod for its Mindseye Expandable Port for neurosurgical procedures. The company touts the device as the first minimally invasive, retractable deep brain access system for use in the treatment of stroke, cancer and other conditions.
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3D heart illustration showing tricuspid and bicuspid valves

Medtronic to kick off study for transcatheter valve system after gaining breakthrough status

Sep. 9, 2020
By Liz Hollis
No Comments
Medtronic plc is celebrating its latest win following the U.S. FDA’s approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement system in patients with severe, symptomatic tricuspid regurgitation. The action comes after the agency granted breakthrough device designation for the system.
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Regulatory front for Sept. 9, 2020

Sep. 9, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neuromatrix, Snyders Heart Valve, St. Jude Medical, Thermo Fisher Scientific.
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Regulatory actions for Sept. 9, 2020

Sep. 9, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alydia Health, Ka Imaging, Procisedx, Thermo Fisher Scientific.
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Regulatory actions for Sept. 9, 2020

Sep. 9, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Apros, Ascendis, Beigene, Biomarin, Canbridge, Moleculin, Nanomab, Peptilogics, Precision, Reneo, Sellas.
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Architectural pillars

Regulatory front for Sept. 8, 2020

Sep. 8, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma, including: Amarin, CDC, COVID-19 Treatment Guidelines Panel, Dr. Reddy’s, FDA, Hikma, NIH.
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Women scientists in lab

Novacyt launches respiratory virus test panel that differentiates COVID-19 from common winter diseases

Sep. 8, 2020
By Bernard Banga
No Comments
PARIS – Novacyt SA has obtained CE marking approval for its polymerase chain reaction (PCR) respiratory virus test panel, Winterplex.
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U.S. FDA headquarters

FDA panel votes to affirm agency proposal to down-classify bone growth stimulators

Sep. 8, 2020
By Mark McCarty
No Comments
The agenda for the U.S. FDA’s Sept. 8-9 advisory hearing includes a proposed down-classification of bone growth stimulator (BGS) devices to class II, but while the proposal met some resistance from an industry group, the panel sided with the FDA and declared BGS units ready for prime time as 510(k) devices.
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Regulatory front for Sept. 8, 2020

Sep. 8, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ocular Therapeutix.
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Regulatory actions for Sept. 8, 2020

Sep. 8, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inspiremd, Roche, Theranica.
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