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Home » Topics » Devices » Submissions and Approvals

Submissions and Approvals
Submissions and Approvals RSS Feed RSS

Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

December 1, 2023
The warning comes after the FDA says it received more than 270 medical device reports. Read More

FDA Gives Green Light to Medtronic’s Symplicity Renal Denervation System

November 30, 2023
The thumbs-up for Medtronic comes only days after FDA approval of Recor’s Paradise ultrasound RDN. Read More

Vivos Gets FDA Nod for Sleep Apnea Oral Device, While Philips Wrestles With Yet Another CPAP Safety Issue

November 29, 2023
Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical implants — while Philips Respironics deals with potential overheating issues in its DreamStation 2 CPAP devices. Read More

Positive Findings Generated by Element Science’s Jewel Wearable Cardiac Defibrillator

November 29, 2023
The device provides added patient comfort and convenience due to its lightweight design. Read More

Data ‘Incident’ Is Now a Breach, Henry Schein Told Customers

November 28, 2023
The incident was discovered by the company on Oct. 14. Read More

Quick Notes — Nov. 22, 2023

November 22, 2023
This edition of Quick Notes highlights a major supplier’s data breach, good news for wearable defibrillator and renal denervation devices, and labeling to remind surgeons about nonapproved mesh products. Read More

FDA Authorization of At-Home Sample Collection for STD Tests Opens 510(k) Pathway

November 20, 2023
The FDA reviewed the Simple 2 Test under the De Novo premarket review pathway. Read More

Renal Denervation to Control Blood Pressure, Dream Sock Baby Monitor Get FDA Nods

November 13, 2023
The Dream Sock met independent lab safety standards following testing in both home and hospital settings. Read More

Quick Notes: European Edition — Nov. 10, 2023

November 10, 2023
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More

Dream Sock Baby Monitor, Renal Denervation to Control Blood Pressure Get FDA Nods

November 9, 2023
A sock that performs pulse oximetry measurement for infants will be available OTC for U.S. consumers by the end of this year, following the FDA’s Wednesday De Novo clearance of Owlet’s Dream Sock baby monitor. Read More

Recommendations on Blood Irradiators Classifications Coming From FDA Panel

November 8, 2023
The devices used to destroy tumor cells in surgical blood collection are currently in regulatory limbo. Read More

Expert Explains How Postpandemic Inspections Could Impact Approvals

November 7, 2023
Learn more at the FDA Inspections vSummit Nov. 8-9. Read More
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