Prellis Biologics raises $9m
Prellis Biologics has raised $8.7 million in a new round of equity financing, according to a recently posed SEC filing.
The San Francisco-based company is developing ultra-fast high-resolution holographic laser printing technology intended for use in creating human organs and tissues, according to its website.
Prellis Biologics offers a number of products based around vascularized tissue structures and extracellular matrices intended to grow human tissues and cells, according to the site.
A total of 11 anonymous investors participated in the round, with the first date of sale noted as having occurred on March 12.
The compa...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Wall Street Beat prellisbiologics Source Type: news
Valeritas inks Israeli distro deal with Tritech Biomed
Valeritas (NSDQ:VLRX) said today that it inked an exclusive distribution deal with Tritech Biomed to commercialize its V-Go wearable insulin delivery device designed for patients with Type 2 diabetes in Israel.
Through the deal, the Bridgewater, N.J.-based company said that Tritech Biomed will have rights to promote, market and sell the V-Go system to diabetes clinics and patients in the region.
Read the whole story on our sister site, Drug Delivery Business News
The post Valeritas inks Israeli distro deal with Tritech Biomed appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Diabetes Distribution Drug-Device Combinations Featured Valeritas Source Type: news
BrainScope completes large-scale BrainScope One mTBI validation study
BrainScope said today that it completed a validation study of its BrainScope One device designed to assess head injuries, exploring its ability to assess mild traumatic brain injuries in adolescent and young adult populations.
The Bethesda, Md.-based company ‘s FDA-cleared BrainScope One device is a multi-modal device designed to aid in the objective and rapid assessment and triage of head injury patients, and can assess the “full spectrum of brain injury” including concussions and brain bleeds.
BrainScope said that the study included data from nearly 1,700 subjects and more than 4,000 evaluations perform...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Neurological BrainScope Source Type: news
Appeals court upholds BD win in Retractable Technologies case
A federal appeals court this week upheld a ruling that Becton Dickinson (NYSE:BDX) owes nothing more in a long-running false advertising claims case brought by Retractable Technologies (NYSE:RVP).
The dispute dates back to 2001, when Little Elm, Texas-based RTI sued BD for patent infringement; that case settled for $100 million in 2004. RTI sued again barely three years later, alleging further patent infringement and anti-trust violations. That case was split, with the anti-trust portion stayed while the patent infringement claims were litigated; in July 2011 a federal appeals court decided that case.
The anti-trust pha...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Wall Street Beat bectondickinson Retractable Technologies Inc. Source Type: news
FDA head Gottlieb pledges to release all adverse event reports
Outgoing FDA Commissioner Dr. Scott Gottlieb said in a tweet yesterday that the agency plans to release all medical device adverse event reports to the public.
The move comes only weeks after a Kaiser Health News investigation revealed that millions of adverse event reports have been hidden from the public through the agency’s “alternative summary reporting” repository.
“This is an old database where historical information wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public. We’re now priori...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Source Type: news
FDA targets safety of medical device materials
By Stewart Eisenhart, Emergo Group
US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post FDA targets safety of medical device materials appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
Outcome-based Pricing Initiatives in the Healthcare Industry
By Joe Miles – Global Vice President, Life Sciences (SAP Industries) and Bob Steller – Industry Principle, Life Sciences (Vistex)
A distorted reimbursement model has driven healthcare costs ever higher, and elevated healthcare spend to the top budget item for many governments across the globe. But several major industry players have begun to experiment with outcome-based pricing models as an innovative approach to align reimbursements more closely with positive outcomes, while simultaneously bringing greater stability and predictability to pricing in the life science industry.
Download this eBook to evaluate th...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: MassDevice Tags: Sponsored Content Vistex Source Type: news
Cook Regentec launches ProFusion therapeutic infusion needle
Cook Medical‘s Regentec division said today it launched the ProFusion therapeutic infusion needle designed for the intramuscular or subdermal infusion of therapeutic agents in the U.S. and Canada.
The Indianapolis-based business said that the ProFusion Therapeutic Infusion Needle features multiple sideports arranged in a spiral to aid in the uniform delivery and dispersement of therapeutic agents and a trocar tip to help with placement.
Read the whole story on our sister site, Drug Delivery Business News
The post Cook Regentec launches ProFusion therapeutic infusion needle appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cook Medical Source Type: news
Cook Regentic launches ProFusion therapeutic infusion needle
Cook Medical‘s Regentec division said today it launched the ProFusion therapeutic infusion needle designed for the intramuscular or subdermal infusion of therapeutic agents in the U.S. and Canada.
The Indianapolis-based business said that the ProFusion Therapeutic Infusion Needle features multiple sideports arranged in a spiral to aid in the uniform delivery and dispersement of therapeutic agents and a trocar tip to help with placement.
Read the whole story on our sister site, Drug Delivery Business News
The post Cook Regentic launches ProFusion therapeutic infusion needle appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cook Medical Source Type: news
FDA clears first molybdenum rhenium pedicle screw
The FDA today cleared Mirus‘s Europea pedicle screw system, which is composed of its MoRe proprietary molybdenum rhenium superalloy, making it the first such device approved with the new class of implant material.
The Atlanta-based medical device company said that the MoRe proprietary alloy is intended to provide improved strength, ductility, durability and biological safety.
“Spine deformity surgery in adults remains plagued by the poor performance of current implants with rod failure occurring in 18%-20% of patients. The MoRe alloy shows great promise in improving the durability of adult spine deformity const...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance mirus Source Type: news
Osiris shareholders sue to block $660m merger with Smith & Nephew
A group of Osiris Therapeutics (NSDQ:OSIR) shareholders is suing to block its $660 million acquisition by Smith & Nephew (NYSE:SNN) because the purchase price is too low.
Earlier this month the British orthopedics and wound care giant put $19 per share on the table to acquire Osiris and its regenerative medicine portfolio, representing a 37% premium on the 90-day volume-weighted average for OSIR shares.
The deal is structured as a two-step tender offer, with Osiris chairman & co-founder Peter Friedli agreeing to commit his 30% stake. The acquisition is slated to close during the second quarter, with the 360 peo...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Mergers & Acquisitions Regenerative Medicine Wall Street Beat Osiris Therapeutics Inc. Smith & Nephew Source Type: news
Volpara expands distro deal with GE Healthcare
Volpara Solutions said yesterday that it expanded its distribution agreement with GE Healthcare (NYSE:GE) to include the global distribution of its VolparaDensity software.
Wellington, New Zealand-based Volpara said that its VolparaDensity software is designed to analyze mammograms using machine learning to provide automated, objective and volumetric breast density assessments and a breast density category that correlates to BI-RADS 5th and 5th editions.
“There are still certain signs of breast cancer that are best seen on a mammogram, which is why the Invenia ABUS is used in addition to mammography. ABUS screening ...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Imaging Software / IT Women's Health GE Healthcare Volpara Solutions Source Type: news
Philips buys Direct Radiology
Royal Philips (NYSE:PHG) said this week that it acquired teleradiology platform developer Direct Radiology for an undisclosed amount.
The Amsterdam-based company said that with the acquisition it will be expanding into the teleradiology services field, looking to build on its cloud-based radiology informatics portfolio.
New features slated to be added include teleradiology viewing and reporting capabilities, on-call radiologist services and related exam workflow enhancement applications.
Philips said that currently, Direct Radiology services more than 300 hospitals, imaging centers, mobile imaging services and doctorsR...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Imaging Mergers & Acquisitions Royal Philips Source Type: news
Analogic escapes Labor Dept. suit over alleged pay discrimination
A U.S. Labor Dept. judge last week dismissed a suit the agency brought against Analogic over alleged pay discrimination.
The Labor Dept. sued Analogic in October 2016, alleging that it paid female assembly workers at its Peabody, Mass., headquarters less than their male counterparts after a compliance review by its Office of Federal Contract Compliance Programs.
In a March 22 decision, Administrative Law Judge Colleen Geraghty dismissed the case, ruling that the OFCCP failed to prove that the alleged discrimination took place.
The office “failed to identify the employment practice causing the alleged pay disparity a...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Imaging Legal News Analogic Dept. of Labor Source Type: news
LivaNova ’ s CMS vagus nerve depression device trial must include sham arm
A new U.S. Centers for Medicare & Medicaid Services trial of LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation Therapy system intended to treat treatment-resistant depression will require a sham-control arm, doubling the subject population LivaNova originally expected.
The trial, which the London-based company won clearance from CMS for last month, will allow coverage for the VNS devices through a Coverage with Evidence Development framework.
As revealed last month, the trial will be double-blinded, randomized and feature a follow-up of at least one year, the company said.
New data, revealed in a posting on Clinical...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological LivaNova Source Type: news
