Blog Tag: Medical Devices

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

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.

According to Gene Saragnese,

FDA Announces Plans for Alternative Clearance Pathway

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system

Report Finds European Union’s Assessment of High-Risk Medical Devices of Low Quality

A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research) concluded that assessments of high-risk medical devices in the European Union were

Digital Currencies and Blockchain in the Medical Arena

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that blockchain

Medical Device Compared to ‘Star Trek Tricorder’ Presented at AACC

Medical Device Compared to ‘Star Trek Tricorder’ Presented at AACC

Basil Leaf Technologies recently presented their DxtER device at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo in San Diego.  The DxtER device has been compared to the Star Trek medical Tricorder, winning first place 

FDA to Create New Digital Health Unit

The FDA has announced that it will create a new unit responsible for overseeing digital health products.  According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define “what clinical

Philips Buys RespirTech for Undisclosed Amount

Philips Buys RespirTech for Undisclosed Amount

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests, which

Former Lutonix VP Pleads Guilty to Trade Secret Theft

On May 9, 2017, according to court records, Christopher Barry, former Vice President of R&D at Lutonix Inc., pled guilty to stealing Lutonix’s trade secrets in the form of several confidential electronic files.  According to the

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world.  According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access to their

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).

According to Novocure’s press release, the final results of the EF-14 clinical

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016.  According to the press release, the noddle gives patients who are unable to speak a way to communicate

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016,

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says 

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015.  CB Insights has released a report on the funding and deal activity within the medical device industry since

The Brexit Effect on Medical Devices

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU).  Until the breakup becomes official, British legislation should remain fully

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices.

The draft guidance

FDA Approves AspireAssist Obesity Device

FDA Approves AspireAssist Obesity Device

On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.  According to a press release

Cuba an Untapped Market for Medical Device Exports

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014.  This is not surprising since it also produced the largest share

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.

ESDs have been used to reduce or eliminate self-injurious