Jordan Gottdank on Medical Devices

BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment

Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD)....more

10/11/2018 / FDA De Novo Clearance , Israel , Medical Devices

FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse. With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA...more

7/25/2018 / Drug & Alcohol Abuse , Food and Drug Administration (FDA) , Innovative Technology , Medical Devices , Opioid

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device....more

2/22/2018 / 21st Century Cures Act , Expedited FDA Approval , FDA Approval , Medical Devices

Speedboat RS2 Endoscopic Device Receives FDA Clearance

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel....more

9/13/2017 / Cancer , Expedited FDA Approval , Food and Drug Administration (FDA) , Medical Devices

Novocure Announces Optune™ Wearable Device Improves Glioblastoma Survival Rates

Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM)....more

4/10/2017 / Cancer , Clinical Trials , Medical Devices , Wearable Technology

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

11/15/2016 / Clinical Evaluations , Draft Guidance , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Proposed Guidance , Public Comment , Software

Second Sight Announces Positive Five-Year Data from Argus II Retinal Prosthesis System

Second Sight announced in a press release the publication of positive results from a long-term clinical trial of the Argus II Retinal Prosthesis System. According to the press release, the five-year trial included 30...more

8/2/2016 / Clinical Trials , Medical Devices

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

4/29/2016 / FDA Device Bans , Food and Drug Administration (FDA) , Medical Devices , Proposed Regulation , Public Comment , Public Health , Public Safety

Stryker to Acquire Sage Products

According to its recent press release, Stryker Corporation has reached an agreement to acquire Sage Products, LLC from Chicago private equity firm Madison Dearborn Partners in a $2.775 billion cash transaction. Stryker...more

3/15/2016 / Acquisitions , Medical Devices , Pharmaceutical Industry , Stryker

Jordan Gottdank

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