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Age Well with Smart HealthTech
America is going gray. According to U.S. Census data, in 2030 even the youngest Baby Boomers will have reached 65, and older Americans will make up 21 percent of the population. That’s up from 15 percent today. By 2060, nearly a quarter of Americans will be at least 65 and a half million will reach age 100. These changing demographics give urgency to the concept of “aging in place.” Nobody wants to lose their independence, but that’s the reality for many who are forced from their homes by cardiovascular disease, stroke, cancer, diabetes or other chron...
Source: MDDI - August 19, 2019 Category: Medical Devices Authors: Stephanie Van Ness Tags: Digital Health Source Type: news

Stroke Rehab Technology Aims To Speed Healing
Watching someone who has suffered a stroke try to perform everyday actions such as walking down the sidewalk or even bringing a cup to their lips can serve as a sobering reminder of how fragile full and robust health is, and also serves as an inspiration for those dedicated to improving the lives of those patients. Steven Plymale, recently named CEO of Toronto-based MyndTec, said his reaction to watching videos of patients using the company's MyndMove functional electrical stimulation (FES) rehabilitation system was one of the reasons he joined MyndTec. "They are very compelling," Plymale said of the demonstration videos,�...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Greg Goth Tags: Electronics Source Type: news

Silk Road Medical Announces FDA 510(k) Clearance And First Patients Treated In the US with the Next Generation ENROUTE® Transcarotid Neuroprotection System
Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the United States Food and Drug Administration (US FDA) has granted 510(k) clearance for its next generation ENROUTE Transcarotid Neuroprotection System (NPS).
Source: Medical Design Online News - April 18, 2016 Category: Medical Equipment Source Type: news

Stroke Prevention: BIOTRONIK Announces FDA Approval Of BioMonitor 2 Insertable Cardiac Monitor
BIOTRONIK, a leader in cardio- and endovascular medical technology, today announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.
Source: Medical Design Online News - April 13, 2016 Category: Medical Equipment Source Type: news

J&J’s Ethicon loses $9.8m stapler suit
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon lost a $9.8 million suit over injuries caused to a patient by a defective Ethicon PPH 03 hemorrhoid stapler. The case was decided in the Alameda County Superior Court, according to the plaintiff’s counsel, the Alexander Law Group, LLP. The plaintiff alleged that during surgery in January 2012, the defective staple misfired, sealing the patient’s anal canal shut and leading to 21 days of emergency hospitalization, massive infection and resulting abdominal surgeries including a full laparotomy and colostomy. “This is a victory for all those who have been harmed by...
Source: Mass Device - December 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Legal News Business/Financial News Ethicon Endo-Surgery Johnson & Johnson Source Type: news

PathMaker Neurosystems Inc. Receives Expedited Access Pathway Designation From FDA For MyoRegulator
PathMaker Neurosystems'MyoRegulatorPM-2200 system has received Expedited Access Pathway (EAP) designation and priority processing status from the U.S. Food and Drug Administration (FDA). MyoRegulator is PathMaker’s first product, and is being developed for the treatment of muscle spasticity found in patients with stroke, cerebral palsy (CP), multiple sclerosis (MS), spinal cord injury (SCI), traumatic brain injury (TBI) and numerous other neurological conditions.
Source: Medical Design Online News - November 3, 2015 Category: Medical Equipment Source Type: news

Public Workshop – Acute Ischemic Stroke Medical Devices Trials Workshop, October 6, 2015
The Food and Drug Administration (FDA) is announcing a public Workshop “Acute Ischemic Stroke Medical Devices Trials.” The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 8, 2015 Category: Medical Equipment Source Type: news

Public Workshop ? Acute Ischemic Stroke Medical Devices Trials Workshop, October 6, 2015
The Food and Drug Administration (FDA) is announcing a public Workshop ?Acute Ischemic Stroke Medical Devices Trials.? The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 8, 2015 Category: Medical Equipment Source Type: news

Medtronic Drug-Coated Balloon Receives FDA Approval For Treating Peripheral Artery Disease In Upper Leg
Medtronic, Inc. announced recently that the U.S. Food and Drug Administration (FDA) has approved the company's IN.PACT Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) in the upper leg, a serious and common cardiovascular condition that causes pain in the legs and is known to be associated with a four- to five-fold increase in risk for heart attack and stroke.
Source: Medical Design Online News - January 6, 2015 Category: Medical Equipment Source Type: news