Zimmer Biomet reveals FDA warning letter
Zimmer Biomet (NYSE:ZBH) today revealed a warning letter it received in late may over non-conformities with good manufacturing practice requirements for its quality system regulation at its Montreal,...
View ArticleFDA clears Cereve sleep-aid device
Sleep-focused company Cereve said today it won FDA 510(k) clearance for its Cereve Sleep System device designed to reduce latency to stage 1 and stage 2 sleep for patients suffering from insomnia. The...
View ArticleESC adds St. Jude’s CardioMems to guidelines for directed HF therapy
The European Society of Cardiology has added St. Jude Medical‘s (NYSE:STJ) CardioMems heart failure system to its guidelines as a “directed therapy management and monitoring tool for heart failure...
View ArticleGW Plastics Wins Plastics News’ 2015 “Sustained Excellence” Award
GW Plastics is pleased to announce that it has been selected as Plastics News’ “Sustained Excellence” award winner for 2015. This prestigious award honoring continued excellence in well- rounded...
View ArticleCSS to attend MD&M East in New York
CSS, an international manufacturer of precision metal parts and assemblies for leaders in the medical, aerospace, firearms and defense, and transportation industries, is pleased to announce it will be...
View ArticleSunrise Labs welcomes Doug Browne and Dave Hibbard to the team
Sunrise Labs, an ISO-13485 certified medical device product development firm in Auburn, NH, is proud to announce the addition of two engineers in leadership roles; Doug Browne, Director of Mechanical...
View ArticleVertera Spine touts 1st procedures with Cohere spinal fusion device
Vertera Spine said today that the 1st procedures using its Cohere cervical interbody fusion system were performed recently, with a full market release of the device on the horizon. The Cohere device is...
View ArticleMilestone Scientific touts CompuFlo trial completion, plans FDA submission
Milestone Scientific‘s (OTC:MLSS) said today it completed the pivotal study of its CompuFlo epidural computer controlled system, investigating the safety and efficacy of the epidural space verification...
View ArticleMassDevice.com +5 | The top 5 medtech stories for June 6, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
View ArticleFirst Ray wins FDA nod for SpeedButton soft-tissue-to-bone attachment device
Startup surgical device developer First Ray said today it won FDA 510(k) clearance for its SpeedButton system designed to attach soft tissue to bone. The SpeedButton device attaches soft tissue to bone...
View ArticleStaying ontop of hydrocephalus shunt failure with ShuntCheck
Antonio Venus-Reeve, 14, had his first shunt surgery for hydrocephalus when he was 2½ months old. Born at 25 weeks’ gestation, weighing less than two pounds, he had a serious brain bleed seven days...
View ArticleNuVasive picks up neuro monitoring provider Biotronic NeuroNetwork for $98m
NuVasive Inc. (NSDQ:NUVA) said yesterday it bought intraoperative neurophysiological monitoring service provider Biotronic NeuroNetwork for $98 million in cash. Biotronic NeuroNetwork provides...
View ArticleAvita Medical signs Malaysian distro deal with Mintcare
Avita Medical (ASX:AVH) said today it inked a distribution deal with Asia-Pacific specialized wound care product distributor Mintcare. Through the deal, Mintcare will distribute Avita’s wound care...
View ArticleZimmer Biomet to drop $1B on spine-focused LDR Holding
Zimmer Biomet (NYSE:ZBH) said today it is buying spinal medical device company LDR Holding for approximately $1 billion. Boards from both companies approved the acquisition agreement, the company said,...
View ArticleB. Braun files IV cath patent infringement suit against Becton Dickinson
B. Braun Medical said today it, along with its subsidiaries filed a patent infringement lawsuit against Becton Dickinson & Co. (NYSE:BDX) over 10 U.S. patents related to IV catheter safety...
View ArticleMedtronic expects rev from surgical bot system by FY2019
On Monday, Medical device giant Medtronic (NYSE:MDT) unveiled plans that would see income from a robotic surgery unit by 2019, an entry into the orthopedic hip and knee replacement market in 2017 and...
View ArticleBiden announces U.S. project to promote cancer data sharing
(Reuters) – U.S. Vice President Joe Biden said on Monday the “moonshot” initiative he leads aimed at finding cures for cancer was “the only bipartisan thing left in America” and called for more...
View ArticleGuided Therapeutics inks Chinese Luviva licensing deal
Guided Therapeutics (OTC:GTHP) said today it inked a licensing deal with Shenghuo Medical to manufacture and market its LuViva advanced cervical scan system in China and several other Southeast Asian...
View ArticleDelcath raises $35m in private placement
Delcath (NSDQ:DCTH) said today it inked a securities purchase agreement with an investor for $35 million in senior convertible notes and stock purchase warrants, expecting to bring in $32.2 million to...
View ArticleNevro announces $125m funding round
Nevro Corp. (NYSE:NVRO) today revealed a $125 million round of financing through the sale of convertible senior notes, due 2021, to support repayment of a term loan agreement, general corporate...
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