FDA Panel: Too early to pull textured breast implants over cancer risk, need more data
A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to. The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link to ...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Oncology Women's Health Source Type: news

Johnson & Johnson touts drug-releasing lens studies for itchy eyes
Contact lenses imbued with an antihistamine drug reduced itchy eyes in a pair of older studies funded by the vision business at Johnson & Johnson(NYSE:JNJ), the company said today. The Phase 3 studies, conducted in 2007, involved a total of 244 patients, divided into three cohorts. In the first patients wore a plain lens made of etafilcon a in one eye and the same lens treated with 0.019mg of the drug ketotifen in the other eye. In the second group, patients wore treated lenses in both eyes; the third group was the control, consisting of patients wearing placebo lenses in both eyes. There were about 40 subjects in ...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Optical/Ophthalmic johnsonandjohnson Source Type: news

Medtronic launches Shanghai-based medtech incubator
Medtronic (NYSE:MDT) said yesterday that it launched a new incubator and accelerator in Shanghai, China looking to support early-stage medtech companies both in the region and globally. The newly launched incubator, dubbed the Medtronic MedTech Innovation Accelerator, resides in the Pujiang International Science and TechnologyCity in Shanghai’s Minhang District, the Fridley, Minn.-based company said. “For nearly 70 years, Medtronic has been focusing on developing transformative medical technologies that improve lives. We promote meaningful innovation by continually investing in internal R&D, as well as exp...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Research & Development Medtronic Source Type: news

Ethicon seeks data on Neuwave liver ablations
  Ethicon’s Neuwave is a target ablation tool for small to large lesions, as well as a resection tool. (Image from Ethicon) Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it has launched a global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company’s Neuwave microwave ablation system. The multicenter, observational registry will follow approximately 1,500 patients worldwide for five years from the date of their first liver ablation procedure with the Neuwave system, a minimally invasive microwave ablation technology that uses heat tra...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog News Well Research & Development Surgical Ethicon johnson&johnson societyofinterventionalradiology Source Type: news

Medtronic responds to usability concerns for its MiniMed 670G insulin pump
Medtronic (NYSE:MDT) responded to a study presented this week which highlighted usability concerns with its MiniMed 670G automated insulin pump, writing that the company had “made many enhancements to the system since the study was done which would likely mitigate many of the issues experienced.” Earlier this week, physicians from Boston Children’s Hospital reported that nearly one-fifth of participants in a real-world study of the MiniMed 670G stopped using the system within months of it being prescribed, citing dissatisfaction with the technical demands of the system. Get the full story at our sister si...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Featured Pharmaceuticals Wall Street Beat Boston Children's Hospital Medtronic Source Type: news

FDA reviews requirements for nicotine replacement therapy product labels
By Stephanie Larson and Richard Featherstone, Emergo Group Nicotine replacement therapy (NRT) drug products, such as patches, gum and lozenges, have been around for more than 30 years. More novel products such as e-cigarettes provide additional choices for people using NRT for smoking cessation. But, like any other drug delivery mechanism, there are risks as well as benefits when using NRT drug products. While the technology has been marching ahead, regulators have been taking an increased interest in how to manage the risks of harm associated with using such products. Get the full story here at the Emergo Group’s blog. ...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

FDA clears Genetesis ’ CardioFlux biomagnetic cardiac imager
Genetesis said last Friday it won FDA 510(k) clearance for its CardioFlux biomagnetic cardiac imaging platform. The newly cleared platform combines the CardioFlux magnetocardiograph with an integrated Faraday Analytical Cloud, the Mason, Ohio-based company said. Genetesis said that the CardioFlux uses a next-gen version of magnetocardiography that eliminates the need for liquid helium cooling, which had previously served as an obstacle to the wide-scale commercial adoption of MCG. Data from the CardioFlux is sent securely to the Faraday Analytical Cloud where it can be reviewed by physicians. “This milestone provides...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Imaging Regulatory/Compliance Genetesis Source Type: news

Masimo wins FDA 510(k) for Rad-67 pulse co-oximeter
Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its Rad-67 pulse co-oximeter system. The Rad-67 offers both Rainbow non-invasive hemoglobin measurement and measure-through motion and low perfusion SET pulse oximetry, and can be used with the Irvine, Calif.-based company’s Rainbow DCI-mini sensor for spot-check monitoring. The system also features a rechargeable battery with a six-hour run time and a high-resolution color display with touchscreen navigation. Masimo said that the combination of spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin makes it viable as a s...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Masimo Source Type: news

Omron wins FDA nod for combined blood pressure monitor, EKG
Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release. The device, which was developed in collaboration with AliveCor, allows users to monitor both high blood pressure and atrial fibrillation, which the company said are critical risk factors for stroke. The newly cleared device is designed to sync with the Omron Connect mobile application to store, track and share heart health data with physicians to improve outcomes, the company said in its original product release. The combined product, under the moniker BP7900, was cle...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance AliveCor Omron Source Type: news

Elekta wins Health Canada approval for Elekta Unity MR radiation therapy system
Elekta (STO:EKTA B) said today that it won Health Canada approval for its Elekta Unity magnetic resonance radiation therapy system. The Elekta Unity system consists of a high-field 1.5 Tesla MRI scanner and a linear accelerator alongside integrated real-time dose planning software for target monitoring, the Stockholm-based company said. Elekta added that its Elekta Unity device has the ability to reshape doses based on daily changes in shape, size and the position of the tumor and surrounding healthy anatomy. “We are pleased to have achieved this important milestone toward making Elekta Unity available in Canada a...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: Oncology Radiosurgery/Radiation therapy Regulatory/Compliance Elekta Source Type: news

Thermo Fisher to drop $1.7B on gene therapy maker Brammer Bio
Thermo Fisher (NYSE:TMO) said today that it will acquire gene and cell therapy manufacturer Brammer Bio for $1.7 billion in cash. Brammer Bio is a viral vector contract developer and manufacturer of gene therapies and gene-modified cell therapies for biopharma customers. The Cambridge, Mass.-based business has nearly 600 employees at primary locations in Massachusetts and Alachua, Fla. Get the full story on our sister site, Medical Design & Outsourcing. The post Thermo Fisher to drop $1.7B on gene therapy maker Brammer Bio appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Biotech Blog Business/Financial News Featured Mergers & Acquisitions News Well Outsourcing Wall Street Beat brammerbio Thermo Fisher Scientific Source Type: news

FDA clears shorter protocol for Nexstim ’ s NBT TMS depression treatment
Nexstim said today that it won FDA 510(k) clearance for a new, shorter treatment protocol for its Navigated Brain Therapy transcranial magnetic stimulation system intended to treat major depressive disorder. The Helsinki-based company said that the FDA cleared the system for a Theta Burst Stimulation treatment protocol, which is much shorter than its previously cleared treatment protocol. The newly cleared protocol for the NBT system takes only 3 minutes per session, significantly shorter than the 37-minute standard treatment protocol the company won FDA clearance for in November 2017. Nexstim said that a large multi-cente...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Nexstim Source Type: news

CardioFocus wins CE Mark for HeartLight X3 endoscopic ablation system
CardioFocus said today that it won CE Mark approval in the European Union for its HeartLight X3 endoscopic ablation system. The Marlborough, Mass.-based company said that the HeartLight X3 is its third-generation endoscopic ablation system intended to perform pulmonary vein isolation procedures using laser energy to block the abnormal electrical pathways that cause atrial fibrillation. The newly cleared HeartLight X3 uses direct tissue visualization, titratable laser energy and compliant balloon technology alongside a motor control system to allow for high-speed, circumferential lesion creation, CardioFocus said. Approval...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Cardiofocus Source Type: news

Report: Outgoing FDA head Gottlieb calls for better regulation of EHRs
Outgoing FDA commissioner Dr. Scott Gottlieb is calling for stricter oversight of electronic health records systems, according to a report from Kaiser Health News. The call for heightened scrutiny comes in response to a investigative report, published by KHN and Fortune magazine, alleging a number of serious issues that have arisen over the past 10 years as the U.S. government has pushed to switch from paper to digital records systems. In the report, investigators shed light on thousands of reported deaths, injuries and near misses tied to EHR system, as well as other concerns raised as more systems move towards digital he...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: Electronic Medical Records Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Study examines usability of hybrid closed-loop insulin pump
Data from an 83-person study of Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop insulin pump showed that nearly one-fifth of participants stopped using the device after struggling with the technical demands of the system, researchers reported. Medtronic’s MiniMed 670G device is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every five minutes and automating the administration of insulin. Get the full story at our sister site, Drug Delivery Business News. The post Study examines usability of hybrid closed-loop insulin pump appeared first on Mass...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Featured Pharmaceuticals Boston Children's Hospital Medtronic Source Type: news