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Total 23 results found since Jan 2013.

Consider the Promises and Challenges of Medical Image Analyses Using Machine Learning
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Artifical intelligence (AI) has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly and offering providers and patients with life-changing insights into a variety of diseases, injuries, and conditions that may be hard to detect without the supplemental technology. Images are the largest source...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Partha S. Anbil and Michael T. Ricci Tags: Imaging Source Type: news

Facebook Makes Its Healthcare Debut
Cristin Moran, CEO of Growth Science, said it best last week at MD&M Minneapolis when she said almost every industry is interested in healthcare. We've already seen Apple, Amazon, Microsoft, and Google make power moves in healthcare, so it should come as no surprise that Facebook has now made its healthcare debut. The social media giant announced this week that it is developing products and partnerships aimed at connecting people with healthcare resources, starting with a new Preventive Health tool for U.S. consumers. Facebook said it is working with U.S. health organizations to offer the new tool, which is...
Source: MDDI - October 30, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

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

FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency. In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job. On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news

The World & #039;s Most Innovative Medtech Companies
Innovation is medtech's middle name, so it's always a nice surprise to see companies in the industry honored for being innovative. Fast Company released a list Wednesday recognizing 10 such companies in the biotech sector. Below, we highlight the companies on the list that are developing medical devices or diagnostics (excluding companies that are more on the pharma and biotech side of the life sciences industry). Foundation Medicine Foundation Medicine develops genomic profiling assays to pair cancer patients with relevant treatments and clinical trials. The company was ranked first among the Top 1...
Source: MDDI - February 20, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices. “This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news

Korean JLK Inspection launches AI-powered imaging diag system
Korean JLK Inspection said yesterday that it launched its AIHub artificial intelligence-powered medical image diagnostics platform. The newly launched AIHub system is designed to analyze images from a number of different imaging modalities, including magnetic resonance imaging, computed tomography, X-ray and mammography, the Seoul-based company said. JLK Inspection claims the system can detect and monitor for more than 30 medical conditions in 14 regions of the body. The company added that the system is focused on brain diseases and conditions including ischemic stroke, hemorrhagic stroke, brain aneurysm and Alzheimer̵...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Imaging Software / IT jlkinspection Source Type: news

J & J ’ s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device. The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications. Approval of the device came based on data from the Arise II study, in which investigators reported being able to restore blood flow in 80% of patients treated within three passes, and in approximately 50% within a single pass. More than 66% of patients ...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular cerenovus johnsonandjohnson Source Type: news

FDA Lays the Smackdown on Illegal Stem Cell Clinics
FDA is cracking down on stem cell clinics that market unapproved products and don't meet good manufacturing practice requirements. On behalf of the agency, the Department of Justice filed two complaints in federal court this week seeking permanent injunctions against a Florida-based clinic and a California-based clinic.  “Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after re...
Source: MDDI - May 10, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

5 Trends Medtech Should Be Talking About
Recently I chatted with Candace Roulo, managing editor of Advanced Manufacturing Now, about some of the most important trends in medtech and the technologies that are taking the industry to the next level. Click below to listen to the podcast, or read on for select highlights of the conversation – what I consider to be five trends medtech professionals should be talking about. 128-Advanced_Manufacturing_Now-UBM.mp3 Explore all of these trends in depth at the BIOMEDevice Boston Conference and Expo, April 18-19, 2018. Use promo code "SAVE100" for $100 off conference registration and free expo access.   1. Muc...
Source: MDDI - April 6, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: BIOMEDevice Boston Business Digital Health Source Type: news

Medtronic Finds Another Value-Based Care Partner
Dublin, Ireland-based Medtronic continues to lead the charge toward value-based care with a new five-year strategic partnership with Lehigh Valley Health Network (LVHN), an eight-hospital network in Northeastern Pennsylvania. The partnership is aimed at developing innovative, sustainable, and integrated value-based solutions to improve healthcare outcomes for LVHN's patients. The partnership will create programs that span more than 70 major medical conditions, with the goal of positively impacting as many as 500,000 patients and reducing their cost of care by $100 million.  The organizations said the partnership will leve...
Source: MDDI - February 28, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Medtronic inks 5-year partnership with Lehigh Valley Health Network
Medtronic (NYSE:MDT) today announced a five-year strategic partnership with Lehigh Valley Health Network looking to develop value-based solutions for patients within the network. The LVHN serves a total of eight hospitals across seven counties in Northeastern Pennsylvania, Fridley, Minn.-based Medtronic said. The healthcare network’s partnership with Medtronic will aim to create programs for more than 70 major medical conditions with goals of reducing cost by $100 million and improving outcomes for as many as 500,000 patients. “This agreement is exciting not only for Medtronic and LVHN, but also for the health...
Source: Mass Device - February 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Hospital Care Medtronic Source Type: news

SQI Test Detects Heart Attack Before It Happens
There isn't a  shortage in the number of companies developing tests for cancer detection. However, it’s a far different story when it comes to diagnostics for cardiovascular diseases. Two companies are bringing a huge spotlight to the space and have created a test that can predict a cardiac event. SQI Diagnostics and Predictive Health Diagnostics (PHD) announced the validation, commercial transition, and development of the PULS Cardiac Test. "This is a serum blood test for all those people who look healthy and have normal lipids, yet still go on to have a heart attack," Douglas Harrington, CEO of PHD, told MD+DI.  "...
Source: MDDI - February 28, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular IVD Source Type: news

The Biomarker Disruptor
Would you rather get a biopsy or a blood test to check for prostate cancer? Quanterix chairman/CEO Kevin Hrusovsky said with the help of his company's latest product, the SR-X Ultra-Sensitive Biomarker Detection System, a simple blood test could replace, or complement, invasive diagnostic procedures. Using digital technology, the SR-X can detect cancer, neurological disorders, inflammatory and infectious diseases, and heart events months or even years earlier, and less invasively, than existing technology.   Using Quanterix's single molecule array (Simoa) science, which is similar to a digital enzyme-linked immunosorbent ...
Source: MDDI - January 16, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: IVD Source Type: news

3 Reasons TAVR Will Continue to Prosper
The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space. Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic stenosi...
Source: MDDI - January 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news