Titan Medical, Teleflex ink collab robotic ligation dev deal
Titan Medical (NSDQ:TMDI) said today that it inked a collaborative development deal with Teleflex (NYSE:TFX) to integrate its polymer ligation technology into Titan’s Sport single-port robotic surgical platform.
Toronto-based Titan Medical said that Wayne, Penn.-based Teleflex’s polymer ligation system is intended for vessel sealing and includes an enhanced clip security feature that has been previously used in millions of cases.
“Our patented, multi-articulating instruments have been developed to facilitate the integration of advanced tools and technologies. This collaboration with Teleflex permits the...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Research & Development Robotics Surgical Teleflex Titan Medical Inc. Source Type: news
Zimmer Biomet wins FDA nod for robotic Rosa One Spine platform
Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its robotic Rosa One Spine System intended for use in robotically assisted minimally invasive complex spine procedures.
The Warsaw, Ind.-based company touted that the Rosa One Spine combines robotics and navigation alongside real-time patient dynamic tracking capabilities.
The system also features 3D intraoperative planning software and a suite of navigation technologies intended to improve implants, instrument placement accuracy and predictability, Zimmer Biomet said.
“Rosa One Spine functions as a dual robotics and navigation technology solut...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Featured Food & Drug Administration (FDA) Regulatory/Compliance Robotics Spinal Zimmer Biomet Source Type: news
DeviceTalks partners with MassMEDIC to highlight the Massachusetts medical device ecosystem at DeviceTalks Boston
For the second year, DeviceTalks and MassMEDIC have partnered to bring the MassMEDIC MedTech Showcase to DeviceTalks Boston on June 5-6.
Boston, MA and Cleveland, OH – DeviceTalks is proud to announce that it has partnered with MassMEDIC for the second year to bring the MassMEDIC MedTech Showcase to DeviceTalks Boston on June 5-6 at the Seaport World Trade Center.
DeviceTalks Boston brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market.
“We are thrilled to be working closely with MassMEDIC to bring Dev...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured DeviceTalks Boston MassMEDIC Source Type: news
Dutch regulators explain no-deal Brexit impact for medical device companies
By Ronald Boumans, Emergo Group
The United Kingdom (UK) may leave the European Union (EU) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the UK and the EU parliaments. The Netherlands and the EU are therefore still preparing for various scenarios. One of those scenarios is that no agreement is reached (a ‘no deal’ scenario). In case of a no deal Brexit, existing legislation concerning medical devices and in-vitro diagnostics will no longer be applicable to the UK as of the withdrawal date at which the UK leaves the EU. The EU legislation does not change, but companies that are based in the...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
Smiths Group unveils Smiths Medical spinout plan, search for new CEO
Smith Medical parent company Smiths Group (LON:SMIN) today announced plans to pursue a demerger with its Smiths Medical business, which will become separately listed in the UK.
Smiths Group said it believes the demerger will strengthen both companies and allow the newly separated medical business to better capitalize on its leading positions, product launches and other value-creating opportunities. The company said it expects to complete the demerger some time during the first half of next year.
“Pursuing a demerger of Smiths Medical will lead to two stronger companies each focusing on accelerating the execution of...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat Smiths Group plc Smiths Medical Source Type: news
Wound Management buys out remaining 50% stake in Cellerate
Wound Management Technologies (OTC:WNDM) said yesterday that it closed a deal to acquire the remaining 50% stake in the Cellerate joint venture it launched last September with The Catalyst Group.
Prior to the acquisition, Wound Management Technologies and The Catalyst Group’s CGI Cellerate RX affiliate had owned equal shares in the spun-out company.
The Cellerate JV maintains an exclusive sublicense to distribute the CellerateRX activated collagen adjuvant into wound care markets in the U.S., Canada and Mexico.
Fort Worth, Texas.-based Wound Management Tech said that Cellerate will now act as a wholly owned subsidia...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Wound Management Technologies Source Type: news
FDA panel: Neuronix Alzheimer ’ s therapy fails to prove efficacy
An FDA advisory panel has recommended against granting de novo clearance to Neuronix’s NeuroAD system intended to slow the progress of mild to moderate Alzheimer’s disease.
NeuroAD is approved for use in Europe, Australia and Israel, but the panel found that while it met FDA safety standards, clinical studies did not prove that it is effective.
NeuroAD uses focused transcranial magnetic stimulation (TMS) to stimulate target areas of the brain responsible for cognitive functions impaired by Alzheimer’s disease, according to the Yoqneam, Israel-based company. This stimulation is designed to induce long-term potentiatio...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Food & Drug Administration (FDA) Neurological Neuromodulation/Neurostimulation News Well neuronix Source Type: news
Senseonics touts patient access program for Eversense CGM
Senseonics (NYSE:SENS) said today that it launched the Eversense Bridge Program, which is designed to improve patient access to Senseonics’ Eversense continuous glucose monitoring system.
The company said that the program can help users confirm their insurance benefits and obtain pre-authorization before sensor placement. The Eversense Bridge Program is also meant to help healthcare providers and patients appeal to insurers regarding denied claims.
Get the full story at our sister site, Drug Delivery Business News.
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Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Diabetes Wall Street Beat Senseonics Source Type: news
Novartis plans Alcon spinout for early April
Novartis (NYSE:NVS) said today that it’s planning to list the shares of its Alcon vision care business April 9 in Switzerland and New York.
Terms for the spinout, announced last June, call for each Novartis shareholder to receive a single ALC share for every five NVS shares at the close of business April 8.
The Swiss SIX exchange and the New York Stock Exchange have each approved the listing, Novartis said.
“Alcon has secured debt financing of $3.5 billion through a group of banks. The Alcon credit rating will be investment-grade following the spin-off. Moody’s Investor Service and S&P Global Ratings ...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Vision Wall Street Beat Alcon Novartis Source Type: news
Varex Imaging to pay $85m for Direct Conversion
Varex Imaging (NSDQ:VREX) said yesterday it inked a deal to acquire linear array digital detector maker Direct Conversion for $84.6 million (EU €75 million).
In the deal, Salt Lake City, Utah-based Varex said that it agreed to acquire at least 90% of the outstanding shares of Stockholm-based Direct Conversion, and that the $84.6 million price tag was for 100% of the company’s outstanding shares.
Varex said that $11.3 million (EU €10 million) of the total offered in the deal will be paid in either Varex common stock or cash on the first anniversary of the closing. The company said it plans to fund the acquisitio...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Mergers & Acquisitions Varex Imaging Source Type: news
Artificial intelligence and medicine: Is it overhyped?
Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver?
[Original image from iStock]AI could possibly fuel the future of medtech, enabling such thrilling innovations as implanted devices that instantly react to minute changes, software that can identify the best treatment options for individuals facing life-threatening conditions and fully-functioning autonomous surgical systems.
But artificial intelligence’s potential also comes with an incredible level of hype.
“AI has the most transformative potential of anything I’ve seen in my life, and I grad...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Health Information Technology Research & Development Software / IT AI artificial intelligence HeartFlow IBM Watson Health idx Scripps Research Institute Source Type: news
Dyve Bioscience touts proof-of-concept study for transdermal painkiller
Dyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare.
The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the placebo group were given lotion without sodium bicarbonate or menthol. Investigators told the participants to report to the clinic within 36 hours of flare onset.
Get the full story at our sister site, Drug Delivery Business News.
The post Dyve Bioscience touts proof-of-concept stud...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Pain Management Pharmaceuticals dyvebioscience Source Type: news
Neovasc shares tumble on 2018 earnings release
Shares in Neovasc (NSDQ:NVCN) have fallen nearly 10% today after the medical device maker posted full year 2018 earnings that showed losses growing to more than triple what it reported in 2017.
The Vancouver-based company posted losses of $109.1 million, or $7.63 per share, on sales of $1.7 million, seeing losses grow 338.7% while sales shrunk 67.5% compared with the previous fiscal year.
“After achieving a steady flow of positive operational and development milestones throughout 2018, we have entered 2019 with significant momentum in the business which is driving increased awareness among cardiologists for both the...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat neovasc Source Type: news
Titan Medical closes $25m offering
Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said today it closed a $25 million public offering.
The Toronto-based company said that it floated approximately 7.4 million units in the offering at a price of $3.40 per unit. Each unit offered was comprised of a single common share of the company and a warrant for an additional common share at a price of $4, set to expire on March 20, 2024.
The offering included a fully-exercised over-allotment option through which the company floated an additional 1.1 million units for an additional approximate $3.8 million, Titan Medical said, bringing the total raised up ...
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat Titan Medical Inc. Source Type: news
Novartis launches COPD inhalers in China
Novartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease.
The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide.
Get the full story at our sister site, Drug Delivery Business News.
The post Novartis launches COPD inhalers in China appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat Novartis Source Type: news
